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nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Director, Business Development (West Coast - SF Based - No Relocation) Open Avid Bioservices FULL_TIME USA Jul 19th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary: Under the general supervision of the Vice President, Business Operations, the Business Development Director will drive increased sales and business for Avid amongst biotechnology, biopharmaceutical and pharmaceutical companies, or other as deemed appropriate, and increasing Avid Bioservices' visibility in the marketplace, while creating mutually beneficial business partnerships. Essential Duties and Responsibilities include the following: Grow revenues and increase the company's market share and book of business within the biopharmaceutical/biotechnology CDMO industry by targeting and meeting with prospective clients to sell the advantages of partnering with Avid: Identify, create, qualify and close on new incremental business opportunities within the biopharmaceutical/biotechnology industry Develop and implement sales and marketing strategies and provide input on these to the VP of Business Operations as requested Maintain relationships with current clients to secure follow on business Submit updates on a monthly basis and activity report on the agreed timeframe to VP of Business Operations Solicit requests for proposals (RFPs), requests for information (RFIs), requests for quotations (RFQs), etc. from clients and potential clients. Own all processes and responses as needed to support client inquires: Communicate information needed to team proposal writer and collaborate together to agree on appropriate process and response to client inquiries As needed, support proposal writer and review customization, writing and assembly of documentation due to client and participate in the process from initiation through drafting of deliverables, addition of needed supplemental information, executive summaries, etc. reviewing and ensuring completion and issuance of responses for all forms of requests for information As necessary, by working with multiple departments to reflect and construct constant and accurate responses and ensure all meet legal requirements and are consistent with our brand positioning With the support of the proposal writer, develop technical, management and cost proposals based on client opportunities, customer needs and competitive offering Partner with proposal writer and other internal departments to draft scope of work, proposed timelines, etc. as well as working potential contracts into final production scheduling Processing price quotations and generating/producing publication-quality technical proposal material very quickly in conformance to clients specification, if provided Along with proposal writer, coordinate and optimize proposal process activities Utilize designated CRM to track and follow up on all client leads, query department productivity reports and build trend reports, i.e. volume of proposals, unique opportunities, configurations by product, others as requested Develop and present PowerPoint presentations demonstrating the company's expertise to potential clients, as well as other client marketing initiatives and collateral material Coordinate, manage, participate and attend industry trade shows, conferences and seminars. Document leads, follow up, opportunities, etc. in appropriate CRM Coordinate and manage client site visits and audits: Provide visibility to internal team by adding all client visits to corporate calendar, and to the calendars of individuals to participate in visits Prepare and provide meeting agenda two weeks in advance and schedule internal team preparation calls to ensure readiness for client visits Request in advance specific presentations from internal team and review presentation to be used during the preparation call Develop, update, maintain and evaluate competitive and industry analysis and intelligence information/database to formulate value proposition story based on client opportunities, competitor behaviors, marketplace dynamics and trends, pricing segmentation and practices, productions costs, competitive positions, and marketing programs Provide data analysis and analytics support for sales cycle related functions in proposal and presentation collateral As appropriate, collaborate with proposal writer to develop pricing models, structuring and negotiate manufacturing contracts, MSAs, CSAs and support project scope of work documentation Deliver strategic market insight for purposes of optimizing sales coverage and market segmentation Develop plans and models that support business requirements and strategic selling initiatives including: customer intelligence, market segmentation and analysis, cross-selling and up-selling campaigns, market based analysis, key performance indicators and metrics, market share Analyze existing customer sales data combined with understanding external market data to deliver the "outside-in" perspective to help further drive revenue and profitability Schedule travel as needed as far ahead as possible and submit expense reports in a timely manner Participate in mandatory team meetings and regularly standing internal calls  People Contact: To perform this job successfully, the Business Development Manager/Director must be able to customarily and regularly interact in a courteous and professional manner with interdepartmental staff and management personnel, vendors and contractors, clients and the general public, including scientific-related discussions.  Travel: Expected to travel domestically and/or internationally by land and/or air as required to secure clients for Avid. Education and/or Experience: Bachelor's degree (B.A or B.S.) in biology, chemistry or similar science disciplines from a four-year college or university and: Minimum five (5) to ten (10) years in CDMO sales positions demonstrating knowledge, capability and expertise in the biologics industry, with specific experience in drug substance manufacturing and development. This includes pharmaceutical, biotech and other accounts. Or equivalent combination of education and experience Demonstrate ability to establish and build professional relationships. Growing and expanding sales and customer base is required Demonstrated ability to work within a team environment, supporting fellow business operations, marketing, proposal writers and project management professionals Demonstrated experience with time in territories with high-volume industry accounts and access to biopharmaceutical accounts Ability to navigate internal teams to ensure the best support of client needs Proficient in Microsoft Word suite of software programs, and others a needed. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Biomanufacturing Associate/Technician (Downstream Purification) Open Avid Bioservices FULL_TIME CA USA Aug 20th, 2019 12:00AM Avid Bioservices, Inc. of Tustin, CA is looking to hire a full-time Biotech Purification Manufacturing Associate / Technician. Are you ready to use your life sciences degree to help people with cancer and other diseases? Do you want to work for a biopharmaceutical company that puts a top value on its workforce? If so, please read on! We offer both competitive base pay and annual merit reviews as well as an employee stock purchase program (ESPP) at the time of hire for each regular employee. This allows you to see your compensation increase as you and the company perform well. We also offer numerous exceptional benefits and perks, including medical, dental, vision, life, long-term disability, 15 days of paid time off (PTO) per year, 8 designated holiday, 4 floating holidays, a 401(k) plan, an employee assistance program (EAP), a pet savings program, appreciation breakfasts, quarterly company socials, free annual flu shots, and more! If this sounds like the right opportunity to put your life sciences degree to work for you and your family, apply today! ABOUT AVID BIOSERVICES, INC. We are a dedicated contract development and manufacturing organization (CDMO) focused on the development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell cultures. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch, and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing, and regulatory strategy, submission, and support. We also provide a variety of process development activities including cell line development and optimization, cell culture and feed optimization, analytical methods development, and product characterization. We are committed to improving the quality of life for people suffering from life-threatening diseases through the development of targeted therapeutics for the treatment of cancer and viral diseases. We want to attract and retain employees who can help us achieve this mission and also share our values of integrity, teamwork, innovation, adaptability, integrity, and passion. That's why we offer a positive and exciting working environment along with competitive salaries and benefits. A DAY IN THE LIFE AS A BIOTECH MANUFACTURING ASSOCIATE / TECHNICIAN As a Biotech Manufacturing Associate / Technician, you play an integral role in ensuring the on-time delivery of quality biopharmaceutical products. You get to participate in a variety of tasks including purification of biologics, keeping up-to-date GMP documentation, writing reports, ordering materials, and scheduling equipment services. You are conscientious about maintaining strict compliance with GMP manufacturing practices as you adhere to our standard operating procedures. With great vigilance, you maintain a cleanroom facility at all times. Before each production run, you ensure that all equipment and materials are in place and ready to go. You operate and maintain equipment such as a bioprocess chromatography skids. You pack, unpack, clean, and operate production scale chromatography columns. Your excellent organizational skills come in handy as you ensure correct consumables are staged and used. You filter biopharmaceutical products using sterile, ultrafiltration, and viral filtration techniques. Using affinity chromatography, size exclusion chromatography, ion-exchange chromatography, hydrophobic interaction, and tangential flow filtration (TFF), you purify antibodies and enzymes. You also do pH and conductivity meter calibration and testing. Finally, using slow, deliberate movement and aseptic techniques, you fill drug substances. Whether preparing media and buffer solutions, or manually cleaning small parts and equipment, you take great care in every step. QUALIFICATIONS FOR A BIOTECH MANUFACTURING ASSOCIATE / TECHNICIAN Bachelor's degree in a life science field such as biology, biotechnology, or chemical engineering; Associate's degree for the Technician level At least two years of relevant life sciences industry experience; 0-1 years for the Technician level At least two years of experience working with large scale liquid chromatography columns or similar equipment; 0-1 years for the Technician level Experience working in a GMP production environment with aseptic techniques Must wear a gown for a class 10,000 cleanroom environment Must be able to work under aseptic conditions in a class 100 environment Do you love the life sciences and the thought of using it to help people? Are you attentive to detail and accuracy? Do you take pride in your work? If so, you might just be perfect for this Biotech Manufacturing Associate / Senior Associate position! WORK SCHEDULE This role at our biopharmaceutical company is a full-time, non-exempt position. Shifts are typically 10 hours on Sunday - Wednesday or Wednesday - Saturday. Overtime is sometimes necessary. Due to manufacturing operations, this role requires flexible working hours. READY TO JOIN OUR BIOPHARMACEUTICAL MANUFACTURING TEAM? EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or protected veteran status. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Automation Technician/Sr. Technician Open Avid Bioservices FULL_TIME CA USA Sep 26th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary/Objective: Automation Technician/Sr. Automation Technician maintains control systems for manufacturing processes and utilities in a maximum state of reliability. Identifies problems and potential issues with control systems and automated processes. Participate in plans, installs, start-up, commissioning, document upgrades/installs of PLC, DDC, DCS, SCADA based control systems for Biopharmaceutical process equipment and Plant Utilities. Serve as a lead in all technical requirements for the facility equipment especially the bioreactors (100L 1000L stainless steel and disposable STR/SUB) in order to ensure that the technical operations are aligned with maximizing production effectiveness and optimizing performance to lower overall operating costs. Partner with operations, quality assurance and any vendors and suppliers in order to create positive relationships to strengthen this proactive role in the facility. Essential Duties and Responsibilities include the following; other duties may be assigned: Troubleshoot different controller software and hardware components. Maintain existing control systems in reliable condition, propose improvements, and train/support manufacturing and maintenance personnel. Perform predictive, preventative and corrective maintenance efforts required to ensure efficient, reliable and uninterrupted plant operations. Also supports the specification, acquisition and installation of equipment especially bioreactors (100L 1000L stainless steel and disposable STR/SUB). Conduct timely/competent root cause analyses. Recommend/implement innovative, efficient and effective corrective actions resulting in stable and capable processes. Track and evaluate critical process data to recommend continuous process improvement. Participate in equipment troubleshooting in order to correct/maintain quality production. Recommend and implement measures to improve production methods, equipment performance, and quality of product. Develop and maintain electrical and P&ID drawings. Support validation and manufacturing projects. Maintain current knowledge of regulatory and industry standards. Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility. Strict adherence to procedures and practices according to FDA regulations. Strong emphasis on documentation according to FDA standards. Adhere to departmental corporate safety policies. Education and Experience Associate or Bachelor Degree in Electrical Engineering, Automation Technology or closely related technical discipline or comprehensive work experience. Automation Technology Certification preferred. Minimum of 3 - 5 years related hands on experience maintaining automated manufacturing systems and equipment, ideally in an FDA / cGMP regulated environment. Experience with DDC, DCS, PLCs, industrial networks, drives, motor controls, sensors, automation components, control instrumentation, proportional valves, servo controls, SCADA, HMI troubleshooting is strongly preferred. Knowledge and familiarity with Wonderware, RSView, panel builder, RS logix 500, Delta system, DeltaV and Rees scientific strongly preferred. Familiar with Air Handler HVAC (Heating, Ventilation & Air-Conditioning) systems. Proven ability to independently learn and troubleshoot systems and devices from manuals, P&IDs, Electrical and Electronic schematics, catalogs and equipment cut-sheets. Proven ability in the use of measurement and test equipment including volt, current, impedance, rpm, conductivity, as well as signal analyzer, network tester, mA source, etc. Familiar with common codes and standards including NEC, IEEE, UL, NEMA, and OSHA. Familiar with electrical circuits including 3 phase 480Vac, 120Vac, and 24Vdc power distribution. Good Technical writing skills. Must have strong attention to detail. Work Schedule and Hours This role is a full-time position. Days of work are Monday through Friday, unless otherwise stated by Supervisor. The employee must also have the ability to be on-call on a rotation schedule and travel less than 5% of the time. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Director, Business Development (East Coast - Boston Based - No Relocation) Open Avid Bioservices FULL_TIME Boston MA USA Sep 26th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary: Under the general supervision of the Vice President, Business Operations, the Business Development Director will drive increased sales and business for Avid amongst biotechnology, biopharmaceutical and pharmaceutical companies, or other as deemed appropriate, and increasing Avid Bioservices' visibility in the marketplace, while creating mutually beneficial business partnerships. Essential Duties and Responsibilities include the following: Grow revenues and increase the company's market share and book of business within the biopharmaceutical/biotechnology CDMO industry by targeting and meeting with prospective clients to sell the advantages of partnering with Avid: Identify, create, qualify and close on new incremental business opportunities within the biopharmaceutical/biotechnology industry Develop and implement sales and marketing strategies and provide input on these to the VP of Business Operations as requested Maintain relationships with current clients to secure follow on business Submit updates on a monthly basis and activity report on the agreed timeframe to VP of Business Operations Solicit requests for proposals (RFPs), requests for information (RFIs), requests for quotations (RFQs), etc. from clients and potential clients. Own all processes and responses as needed to support client inquires: Communicate information needed to team proposal writer and collaborate together to agree on appropriate process and response to client inquiries As needed, support proposal writer and review customization, writing and assembly of documentation due to client and participate in the process from initiation through drafting of deliverables, addition of needed supplemental information, executive summaries, etc. reviewing and ensuring completion and issuance of responses for all forms of requests for information As necessary, by working with multiple departments to reflect and construct constant and accurate responses and ensure all meet legal requirements and are consistent with our brand positioning With the support of the proposal writer, develop technical, management and cost proposals based on client opportunities, customer needs and competitive offering Partner with proposal writer and other internal departments to draft scope of work, proposed timelines, etc. as well as working potential contracts into final production scheduling Processing price quotations and generating/producing publication-quality technical proposal material very quickly in conformance to clients specification, if provided Along with proposal writer, coordinate and optimize proposal process activities Utilize designated CRM to track and follow up on all client leads, query department productivity reports and build trend reports, i.e. volume of proposals, unique opportunities, configurations by product, others as requested Develop and present PowerPoint presentations demonstrating the company's expertise to potential clients, as well as other client marketing initiatives and collateral material Coordinate, manage, participate and attend industry trade shows, conferences and seminars. Document leads, follow up, opportunities, etc. in appropriate CRM Coordinate and manage client site visits and audits: Provide visibility to internal team by adding all client visits to corporate calendar, and to the calendars of individuals to participate in visits Prepare and provide meeting agenda two weeks in advance and schedule internal team preparation calls to ensure readiness for client visits Request in advance specific presentations from internal team and review presentation to be used during the preparation call Develop, update, maintain and evaluate competitive and industry analysis and intelligence information/database to formulate value proposition story based on client opportunities, competitor behaviors, marketplace dynamics and trends, pricing segmentation and practices, productions costs, competitive positions, and marketing programs Provide data analysis and analytics support for sales cycle related functions in proposal and presentation collateral As appropriate, collaborate with proposal writer to develop pricing models, structuring and negotiate manufacturing contracts, MSAs, CSAs and support project scope of work documentation Deliver strategic market insight for purposes of optimizing sales coverage and market segmentation Develop plans and models that support business requirements and strategic selling initiatives including: customer intelligence, market segmentation and analysis, cross-selling and up-selling campaigns, market based analysis, key performance indicators and metrics, market share Analyze existing customer sales data combined with understanding external market data to deliver the "outside-in" perspective to help further drive revenue and profitability Schedule travel as needed as far ahead as possible and submit expense reports in a timely manner Participate in mandatory team meetings and regularly standing internal calls  People Contact: To perform this job successfully, the Business Development Manager/Director must be able to customarily and regularly interact in a courteous and professional manner with interdepartmental staff and management personnel, vendors and contractors, clients and the general public, including scientific-related discussions.  Travel: Expected to travel domestically and/or internationally by land and/or air as required to secure clients for Avid. Education and/or Experience: Bachelor's degree (B.A or B.S.) in biology, chemistry or similar science disciplines from a four-year college or university and: Minimum five (5) to ten (10) years in CDMO sales positions demonstrating knowledge, capability and expertise in the biologics industry, with specific experience in drug substance manufacturing and development. This includes pharmaceutical, biotech and other accounts. Or equivalent combination of education and experience Demonstrate ability to establish and build professional relationships. Growing and expanding sales and customer base is required Demonstrated ability to work within a team environment, supporting fellow business operations, marketing, proposal writers and project management professionals Demonstrated experience with time in territories with high-volume industry accounts and access to biopharmaceutical accounts Ability to navigate internal teams to ensure the best support of client needs Proficient in Microsoft Word suite of software programs, and others a needed. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Calibration Technician (GMP) Open Avid Bioservices FULL_TIME CA USA Oct 28th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary/Objective: Performs calibrations and completes associated documentation across a wide variety of equipment that requires a variety of standards. Essential Duties and Responsibilities include the following; other duties may be assigned: Calibrations - performing calibrations on a scheduled and non-scheduled basis, on a wide variety of equipment. Including but not limited to Pipettes, balances, gauges, and chart recorders. Calibration scheduling Maintaining a schedule/calendar for all necessary calibrations, both equipment and standards. Software - Experience with calibration software, Blue Mountain or equivalent Vendors Maintain all vendor information and documentation relevant to both, the continued vendor qualifications and the calibration, maintenance and repair of company standards. Record keeping maintenance of thorough and complete record for all calibrated items, both equipment and standards, that can be utilized for both a complete device history and traceability back to the NIST standards. Maintenance Ability to perform repair maintenance on equipment as required, completing and maintaining the calibrations. Standards the understanding of and ability to use all types of calibration standards, basic mechanical, pneumatic, electronic and electrical, and sophisticated test equipment. Facilitate Provide knowledge and assistance in ensuring company compliance with current regulations, cGMP requirements, customer requirements, and company objectives. Training - Maintaining current memberships in appropriate organizations or associations, or receiving training either via conference or internet, in order to maintain current understanding of regulations, standards and industry trends in order to provide continuous improvement to the calibration systems. Documentation Prepare calibration instructions and procedures that utilize the principles of measurement science, technical analysis, accuracy and precision specifications. Technical advisor Provide technical expertise and assistance in, quality investigations, root cause analysis, corrective and preventative actions, and calibration requirements in new projects or procedures. Inspections Represent the calibration system and are prepared to explain qualifications, systems, methods and results during audits and inspections. Continuous Improvement - Analyze, assess and continuously improve Calibration practices, procedures and results Education and Experience Bachelor's Degree or equivalent experience/training required. Technical degree preferred. 5 years' experience as an instrumentation technician in a cGMP environment. Experience with calibration software, Blue Mountain or equivalent. Demonstrated ability to determine the appropriate calibration methods for various types of systems, instruments, and loops. Experience with operating and implementing calibration management systems (Cal-Man, Blue Mountain, ect.) a plus. Ability to maintain a GMP compliant record keeping system. Experience in a cGMP and ISO controlled environment. Work Schedule and Hours This role is a full-time position. Days of work are Monday through Friday, unless otherwise stated by Supervisor. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM GMP Lead Quality Control Analyst (In-Process) Open Avid Bioservices FULL_TIME CA USA Oct 28th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary/Objective: The Lead Quality Control Analyst will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment for the QC In-Process team. Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Perform advanced compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results Formulate buffers and reagents for the purpose of performing test methods Write and revise test methods and procedures Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry and endotoxin by LAL and HPLC Perform water testing and raw material sampling and testing Perform QC testing for lot release, stability, development/validation projects, and investigations Other functions include writing study protocols and reports Work with other departments in developing, revising and implementing QC procedures and policies Stay abreast of company cGMPs as well as industry regulations that apply to all job functions Perform sample pick up and sample locating without supervision and with strict adherence to written protocols Perform basic troubleshooting with adherence to SOP and TM Perform other duties as assigned Position Type/Expected Hours of Work: This role is an exempt, full-time position. Due to manufacturing operations, this role requires flexible working hours. Shift work: Wed - Sat 4 days x 10 hours Required Qualifications:  BS degree in Biochemistry, Chemistry, Biology or a related field and 5+ years of biotech industry experience working in a QC or analytical lab. Must have experience with analytical testing, writing reports, GMPs, and regulatory audits. Candidate should also have experience with most if not all of the methodologies listed above. Experience with basic maintenance and troubleshooting of analytical instrumentation is highly desirable. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or protected veteran status. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Internal Auditor, Quality Assurance Open Avid Bioservices FULL_TIME CA USA Oct 29th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary/Objective: As a member of the QA Compliance department, performs a variety of activities to ensure compliance with applicable quality and regulatory requirements. Activities include conducting internal audits, review and compilation of data, tracking of audit commitments and timelines. This position focuses on regulatory compliance, strict adherence to the company's quality policy, in addition to improving and implementing cGMP practices. Essential Functions include but are not limited to the following: Follow company policies and procedures. Establish work priorities to meet targets and timelines. Conduct Internal Audits and provide general support to Quality and Compliance Functions. Maintain QA Compliance systems and audit schedule. Ensure audit timelines are met within established limits and expectations. Update department on QA Compliance metrics and reporting. Review, identify and mitigate gaps within the Quality systems. Assist in audit activities. Review data, records and documents to evaluate compliance. Perform audit agenda and audit report writing, response follow up, review of corrective actions. Revise controlled documents. Data collection and review to assess the effectiveness of audit corrective actions. Perform data analysis and report compliance performance metrics. Prepare compliance related presentations or training materials. Provide logistics support for regulatory agency (FDA and Foreign) inspections and client audits. Technical Duties/Responsibilities: Participate in discrepancy investigations. Ensure discrepancies are thoroughly identified, defined and properly assessed. Participate in company audit readiness activities. Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval. Provide guidance to internal and external customers on best practices for maintaining a quality program. Ensure that the proper policies and procedures are in place. Position Type/Expected Hours of Work: This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8 a.m. to 5 p.m. Qualifications: B.A. or B.S. degree (preferably in Life Science) and at least 2 - 5 years of experience in the pharmaceutical, biopharmaceutical or related industry, or an equivalent combination of education and experience Sound knowledge of cGMPs or equivalent regulations Ability to interpret and relate Quality standards for implementation and review Ability to make sound decisions about scheduling, allocation of resources, and managing priorities Ability to communicate clearly and professionally both in writing and verbally Skillful in problem solving and analytical thinking. Flexibility in work hours to meet business objectives Audit skill and/or certification is preferred. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices, Inc. does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Sr. Specialist, Quality Systems Open Avid Bioservices FULL_TIME CA USA Oct 30th, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary/Objective: The Sr. Quality Systems Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards. This role performs assigned tasks and works to achieve company goals and department objectives by following policies and procedures. Essential Functions include but are not limited to the following: Author, review, edit, and approve discrepancy reports including, but not limited to, reports for deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment. Author, review, edit, and approve corrective and preventive action (CAPA) records; ensure CAPA records meet procedural and regulatory requirements. Author, review, edit, and approve controlled documents including, but not limited to, standard operating procedures (SOPs) and forms. Review testing documentation from the microbiology and chemistry groups. Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams. Maintain a state of inspection readiness; participate in inspection preparation activities; and provide back-room support during client audits and regulatory inspections. Generate departmental performance metrics for review by management. Identify and recommend solutions to potential procedure, process, and system gaps. Independently manage competing priorities with limited instruction. Provide assistance to internal and external customers in support of departmental functions. Follow company policies and procedures. Perform other duties as assigned. Technical Duties/Responsibilities: Excellent technical writing and editing skills Experience in use of quality systems software (quality management systems and/or electronic document management systems) Position Type/Expected Hours of Work: This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8 a.m. to 5 p.m. Qualifications: B.A. or B.S. degree (preferably in Life Science). Minimum of 5 years of experience in the biopharmaceutical industry at the Associate level. Knowledge of cGMPs or equivalent regulations. Ability to interpret Quality standards for implementation. Skills to independently evaluate situations and propose potential solutions. Able to interpret Quality standards for implementation. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices, Inc. does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Biomanufacturing Associate/Technician (Upstream/Buffer/Media Support) Open Avid Bioservices FULL_TIME CA USA Oct 31st, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary/Objective: The Manufacturing Associate/Technician performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including, but not limited to: production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate/Technician will play an integral role in ensuring the production and on-time release of quality products. Essential Duties and Responsibilities include the following; other duties may be assigned: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) Operate and maintain cell culture bioreactors (100L - 2000L stainless steel and disposable STR/SUB) in batch, fed-batch, and perfusion modes Perform equipment cleaning and sterilization manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP) Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a BSC) Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, and CIP skid Harvest operations - pod filtration and TFF system Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department Operate Sartocheck filter integrity testers Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms using cGMP Documentation Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling Identify, escalate, and report deviations (IRs/DRs/CAPAs) Set up critical new manufacturing processes and equipment. Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Technical Operations (MTO), Manufacturing Quality Sciences (MQS) and Validation (VAL) departments. Ensure that equipment and material are available as required for each production run. Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed. Assist in the transfer of technology from PD to cGMP Manufacturing. Assist with periodic technical and compliance investigations, inspections, and audits. Operate and maintain Getinge Autoclave and Gruenberg Oven. Prepare glassware and equipment, media and buffer and perform aseptic filling and daily monitoring of equipment for production. Education and Experience: Science-Related Bachelor's degree (i.e. Biology, Biotechnology, Chemical Engineering) for the Associate level and science-related Associate's degree for the Technician level. Biotech industry experience is required to include a minimum of two to four years cGMP mammalian and/or fermentation cell culture experience at the Associate level and zero to one years at the Technician level. Professional experience working for a contract manufacturing organization (CMO) in the life sciences field is preferred. Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics. Ability to handle and prioritize multiple tasks and projects simultaneously. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.       Ability to write routine reports and correspondence.       Ability to speak effectively before groups of customers or employees of organization. Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment (BSC and LAF). Work Schedule and Hours This role is a full-time, non-exempt position. Due to manufacturing operations, this role requires flexible working hours. Work overtime and weekends as necessary Perform shift work Sun - Wed or Wed - Sat (4 days x 10 hours) EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM
nasdaq:cdmo avidbio.applicantpro.com avidbio.applicantpro.com Nov 15th, 2019 12:00AM Associate Specialist/Specialist, Quality Assurance (GMP) Open Avid Bioservices FULL_TIME CA USA Nov 1st, 2019 12:00AM Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture.  We provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries.  With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, our services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support.  We also provide a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. We are dedicated to the improvement of global patient outcomes by delivering world-class services. Our expertise enables us to partner with our customers to advance their products from clinical development to commercial launch. Do you possess the skills and expertise below to improve patient lives and support patient innovative therapies? If so, apply today! Summary: The Quality Assurance Associate Specialist/Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards. Essential Duties and Responsibilities: Assist in the release of API batches and lots. Release of Manufacturing Buffers and Formulations Review of Manufacturing Batch Production Records - Must have at least 6 months to 1 year or more experience. Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs. Review of testing documentation from Microbiology and Chemistry groups. Assist in compilation and client copying of Batch history records Issue, verify and file documents relating to processes, equipment, facilities and utilities in the manufacture of product. Qualifications: B.S. degree in a Science discipline. Require a minimum 0 - 3 years (3 - 6 years for Specialist) of experience in the biopharmaceutical/biotech industry. Industry experience working for a Contract Development and Manufacturing Organization (CDMO) is highly desirable. Knowledge of cGMPs or equivalent regulations preferred. The ability to interpret Quality standards for implementation is required. Skills to independently evaluate situations and propose potential solutions are essential. Must be able to interpret Quality standards for implementation. Require the ability to communicate clearly and professionally both in writing and verbally. Must have flexibility in problem solving and work hours to meet business objectives. EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER Avid Bioservices, Inc. does not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, age, marital status, genetic information, disability or because the employee or applicant is a protected veteran. Nov 14th, 2019 11:53PM Nov 14th, 2019 11:53PM

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