|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 18th, 2019 12:00AM
|
Analytical Research Associate/Sr. Research Associate, Process Development
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 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 and Qualifications
The Process Development Analytical team is seeking an experienced Analytical Research Associate/Sr. Associate (RA/Sr. RA) who is interested in pursuing a career in developing protein biologics. The primary focus of the RA/Sr. RA will be to develop HPLC, LC-MS, Cell-based and/or ELISA methods. The RA/Sr. RA will work under the guidance of analytical scientists and with process development scientists to identify and characterize protein biologics. This position may also interface with the Quality Control as methods are transferred into that group for cGMP testing.
Essential Duties and Responsibilities include the following; other duties may be assigned:
Perform laboratory tasks to support the development, optimization, validation and routine testing of protein therapeutics via physical (HPLC, LC-MS) and functional (Cell-based, ELISA) protein characterization techniques.
Experience with analytical method development using bioanalytical techniques including spectroscopy, binding affinity, SDS-PAGE, chromatography, ELISA, cell-based, HPLC and/or mass spectrometry.
Demonstrated proficiency in one or more of the following: HPLC, Mass Spectrometry, ELISA, Cell-Based Assays, Binding Kinetics (i.e. Biacore/ForteBio).
Document method development and validation activities according to current practices.
Train analysts on new methods.
Transfer methods to cGMP Quality Control lab, as necessary.
Ability to work in a high paced team environment, meeting deadlines, and prioritizing work under general supervision.
Write development and qualification reports documenting data generated.
Maintain good laboratory notebook and follow cGMP documentation practices.
Provide regular updates to Process Development department.
Education and Experience
Requires a Bachelor's degree in the Biological or Physical Sciences with a minimum of 2-3 years of relevant experience as a Research Associate or minimum of 4-6 years of relevant experience for a Sr. Research Associate, and demonstrated working knowledge of scientific principles.
Work Schedule and Hours
Any scientific staff member can expect to work overtime, including during the weekends. Off-site seminars and conferences, as well as, off-site meetings with clients and regulatory agencies, are a usual occurrence. Occasional overnight travel by land and/or air may be required.
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.
|
|
|
|
|
Jan 17th, 2019 10:13PM
|
Jan 17th, 2019 10:13PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 18th, 2019 12:00AM
|
Maintenance Coordinator/Sr. Coordinator, BM RAM
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 14th, 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
Maintenance Coordinator/Sr. Coordinator will work closely with the Maintenance Management to ensure Facility maintenance activities, projects, are scheduled and running accordingly. This position is responsible for supporting the day to day activities within the Facilities Department. Additionally, position requires problem solving and logical skills to assist in planning, gathering accurate information and improving current maintenance activities.
Essential Functions and Duties include the following; other duties may be assigned:
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Develop daily schedule for maintenance and adjust when necessary.
Establish or adjust work procedures to meet manufacturing and /or work order requests.
Ensure all equipment in the facility is in BM RAM with all necessary PMs in place.
Set up any new equipment PMs into the BM RAM.
Review and analyze reports, records, directives, and confers with management to obtain data required for planning activities, providing status of work, and any problems encountered.
Performs data management of the electronic maintenance records, including scanning/attaching pdf files to asset records in BM RAM.
Filing, storing, organizing, retrieving and developing new files.
Track maintenance activities and communicate effectively to all stakeholders.
Work closely with maintenance technicians to ensure work is completed on time.
Adheres to company policies, procedures, GMPs, and SOPs.
Train maintenance staff to effectively utilize the BM RAM.
Generate reports to analyze the productivity of the department.
Plan and schedule 3rd party maintenance and ensure activities are accurately reflected in BM RAM.
Update Facilities Management, Manufacturing Management, and Quality Engineering on the status of maintenance activities.
Maintain vendor database and vendor pricing/agreement repository for department.
Process requisition orders and purchase orders for supplies, services and equipment.
QualificationsTo perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
Associates degree in Computer Science desired.
4+ years in administrative task in Biological, Pharmaceutical, Dietary, or related industry.
Working knowledge of GMPs and FDA regulations as it pertains to document control.
Familiar with Maintenance software such as CMMS, AMMS, MMS, SAP, BM RAM etc.
Proficiency in computers, databases, word processing and spreadsheets is required.
Highly organized individual is a must.
Certificates and Licenses
Technical or Vocational Certification (Maintenance Planner/Scheduler, Certified Maintenance Coordinator, Maintenance Management Software) a plus.
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.
|
|
|
|
|
Jan 17th, 2019 10:13PM
|
Jan 17th, 2019 10:13PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 18th, 2019 12:00AM
|
Quality Control Analyst (In-Process)
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 17th, 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 Quality Control Analysts 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 basic 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.
Perform the following testing: visual inspection, pH, conductivity, osmolality, spectrophotometry, 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
Should be aware 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
Position Type/Expected Hours of Work:
This role is a full-time, non-exempt position. Flexible schedule due to operations/scheduling.
Shift work: Sun-Wed or Wed-Sat
4 days x 10 hours
Required Qualifications:
BS degree in Biochemistry, Chemistry, Biology or a related field and 2-4 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.
|
|
|
|
|
Jan 17th, 2019 10:13PM
|
Jan 17th, 2019 10:13PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
Quality Specialist for Upstream and Downstream Manufacturing Operations
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 1st, 2019 12:00AM
|
|
Are you a Subject Matter Expert for both Upstream and Downstream operations? If so, we have an opportunity for you to improve patient lives through our manufacturing operations for clinical trial products!
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 Specialist, Manufacturing Quality Sciences will assist in the technical transfer of process from client (s) and/or Process Sciences to Manufacturing scale. Responsible for continuous process improvement in manufactured products.
Where issues or improvements are identified, this role will propose viable solutions including a final product impact assessment. Will identify elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need a complete revision.
Review discrepancies, assist investigation activities and prepare a CAPA as appropriate. Propose innovative methods/procedures for gap analysis and reduction of deviations.
Will prepare written reports and presentations for meetings as assigned.
Review 'Engineering Run' Batch Records prior to final QA review and approval.
Technical Duties/Responsibilities & Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Function as SME on the production floor for both Upstream and Downstream operations
Actively assist in the technology transfer from Process Science (PS) to cGMP Manufacturing.
Assist in the design and execution of studies to support MFG production.
Perform gap analyses on tech transfers.
Write technical risk assessments.
Identify and implement efficiencies for manufacturing processes.
Ability to quickly identify process issues and resolve them expeditiously
Ability to perform sound root cause investigations and identify correct CAPAs
Review batch production records for engineering runs
Supervision Received:
General supervision: routine duties are performed with minimal supervision; standard practices or procedures allow analyst to proceed alone at routine work; work is reviewed upon completion.
Position Type/Expected Hours of Work:
This role is a full-time position with flexible scheduling due to operations/scheduling. General days and hours of work are Monday through Friday 8:00am to 5:00pm, unless otherwise stated by Supervisor. The incumbent may be required to work weekends as necessary.
Education and/or Experience:
A Bachelor's degree in life sciences or engineering or higher is required.
Biopharmaceutical experience is required - the incumbent may possess 2 to 3 years in technical experience in industry or in graduate level studies, or equivalent combination of education and experience.
Minimum of 2 - 3 years' experience working with biologics purification.
Ability to think creatively to address complex problems.
Ability to understand basic cell culture, bioreactor, chromatography theory, viral filtration, and ultrafiltration and be able to apply it to real-time scenarios.
Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write technical reports and correspondence.
Ability to speak effectively before groups of customers or employees of organization.
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
Calibration Technician
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 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
Performs calibrations and completes associated documentation across a wide variety of equipment that requires a variety of standards.
Essential Functions and Duties include the following; other duties may be assigned:
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
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 PM and 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.
Routine Duties & Responsibilities
Confers with vendors, contractors, and other departments.
Complies with all safety policies, practices and procedures.
Participates in proactive team efforts to achieve departmental and company goals.
May determine methods and procedures on new assignments and may provide guidance to other nonexempt personnel.
Relies on experience and judgment to plan and accomplish goals.
Performs a variety of complicated tasks and other duties as assigned.
QualificationsTo perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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 and intervals for various types of systems, instruments, and loops.
Experience with operating and implementing calibration management systems (Cal-Man, Blue Mountain, ect.) a plus.
Instrument supervisor experience a plus.
Ability to establish and maintain a GMP compliant record keeping system.
Experience in a cGMP and ISO controlled environment.
Understanding of, and Experience in the Gravimetric methodology used for pipette calibration.
Certificates and Licenses
Calibration technician certification from ASQ a plus.
NCSLI membership a plus.
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
Analytical Research Associate/Sr. Research Associate, Process Development
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 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 and Qualifications
The Process Development Analytical team is seeking an experienced Analytical Research Associate/Sr. Associate (RA/Sr. RA) who is interested in pursuing a career in developing protein biologics. The primary focus of the RA/Sr. RA will be to develop HPLC, LC-MS, Cell-based and/or ELISA methods. The RA/Sr. RA will work under the guidance of analytical scientists and with process development scientists to identify and characterize protein biologics. This position may also interface with the Quality Control as methods are transferred into that group for cGMP testing.
Essential Duties and Responsibilities include the following; other duties may be assigned:
Perform laboratory tasks to support the development, optimization, validation and routine testing of protein therapeutics via physical (HPLC, LC-MS) and functional (Cell-based, ELISA) protein characterization techniques.
Experience with analytical method development using bioanalytical techniques including spectroscopy, binding affinity, SDS-PAGE, chromatography, ELISA, cell-based, HPLC and/or mass spectrometry.
Demonstrated proficiency in one or more of the following: HPLC, Mass Spectrometry, ELISA, Cell-Based Assays, Binding Kinetics (i.e. Biacore/ForteBio).
Document method development and validation activities according to current practices.
Train analysts on new methods.
Transfer methods to cGMP Quality Control lab, as necessary.
Ability to work in a high paced team environment, meeting deadlines, and prioritizing work under general supervision.
Write development and qualification reports documenting data generated.
Maintain good laboratory notebook and follow cGMP documentation practices.
Provide regular updates to Process Development department.
Education and Experience
Requires a Bachelor's degree in the Biological or Physical Sciences with a minimum of 2-3 years of relevant experience as a Research Associate or minimum of 4-6 years of relevant experience for a Sr. Research Associate, and demonstrated working knowledge of scientific principles.
Work Schedule and Hours
Any scientific staff member can expect to work overtime, including during the weekends. Off-site seminars and conferences, as well as, off-site meetings with clients and regulatory agencies, are a usual occurrence. Occasional overnight travel by land and/or air may be required.
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
Manufacturing Associate/Sr. Associate (Downstream)
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 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/Objective:
The Manufacturing Associate/Sr. Associate performs Product Manufacturing tasks or provides Manufacturing Support in strict compliance with cGMP, under Standard Operating Procedures 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 will play an integral role in ensuring the production and on-time release of quality products.
Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Ensure equipment and materials are in place as required for each production run
Plan and prepare needs for processes and activities
Operate and maintain BioProcess chromatography skid
Pack, unpack, and clean production scale chromatography columns
Antibody and enzyme purification via Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction and Tangential Flow Filtration (TFF)
pH and conductivity meter calibration and testing
Product filtration (sterile filtration, ultrafiltration, viral filtration)
Aseptic technique utilizing excellent hand skills with slow, deliberate movement
Product filling (aseptic processing including media fill qualifications)
Maintain and clean cleanroom facility and equipment
Control and track raw material inventory
GMP documentation
Revise and initiate Batch Production Records, Standard Operation Procedures, study protocols and reports
Lead independent projects as assigned
Other Duties:
Prepare media and buffer solutions
Manually clean small parts and equipment
Filter integrity testing utilizing Sartocheck 3/4 Filter Integrity Tester
Operate and maintain ARS Frontier Autoclave
Operate and maintain Gruenberg Oven
Perform daily monitoring of equipment
Prepare glassware and equipment for production
Position Type/Expected Hours of Work:
This role is a full-time, non-exempt position. Flexible schedule due to operations/scheduling.
Work overtime and weekends as necessary
Shift work: Sun-Wed or Wed-Sat
4 days x 10 hours
Required Qualifications:
Associate's degree (A.A.) or high school diploma required
A minimum of one to two years (three to four years for Sr. level) related life sciences industry experience
Need two years of experience working with large scale liquid chromatography columns or similar equipment
Require experience working in a GMP production environment with aseptic technique
Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
Downstream Research Associate/Sr. Associate, Process Development
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 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/Objective:
The Research Associate provides laboratory support for Process Development and performs a range of activities (while the Sr. position performs at a senior level). The employee may be assigned various tasks within the department to complete.
Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
The Research Associate/Sr. Associate will assist in downstream process development and routine purification of antibodies and proteins using knowledge of AKTA, Unicorn, or other relevant purification platform technologies.
The employee will also assist in performing in-process and/or routine analytical assays to support downstream development effort. Assays will include protein concentration by A280, SDS-PAGE, Blue Native Page, IEF Gels, HPLC and/or ELISA assays.
The Research Associate/Sr. Associate will also assist in scale up and process/tech transfer, and in buffer preparation (including low endotoxin buffers), formulation and/or product stability studies.
The employee will lastly compile, analyze data, and write reports, which will be presented in Process Science Group Meetings.
Required Qualifications:
The Research Associate position requires a BS degree and a minimum of 0-2 years of related experience (3-4 years of related experience for the Sr. level)
Intermediate to advanced knowledge of Microsoft Excel, Microsoft Word, Microsoft Outlook and PowerPoint
Ability to read, analyze, and interpret the most complex documents
Ability to maintain recordkeeping systems
Ability to calculate molarity and normality
Understanding of ion exchange, affinity interaction, size exclusion, and hydrophobic interaction chromatography
Chemical or biological lab experience is highly desired.
Competencies:
To perform the job successfully, an individual should demonstrate the following competencies:
Demonstrates attention to detail. Responds promptly to internal customer needs; responds to requests for services and assistance; meets commitments. Edits work for spelling and grammar; able to read and interpret written information. Exhibits objectivity and openness to others' views; uses time efficiently. Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality. Adapts to changes in the work environment; able to deal with frequent change, delays or unexpected events. Commits long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
Manufacturing Specialist - Operational Documentation Review
|
Open
|
Avid Bioservices
|
FULL_TIME
|
|
|
CA
|
USA
|
Jan 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/Objective:
The Specialist, Manufacturing supports the manufacturing operations team as a resource for reviewing completed formulation and operational batch production records for submission to Quality Assurance. The incumbent will have excellent time management skills to work in a fast-paced and dynamic work environment. The incumbent will be required to ensure formulation and operation GMP documentation are reviewed for good documentation practices and adhere to established quality standards and regulatory guidelines. In addition, the incumbent is responsible for improving manufacturing formulation and operational document submission processes to improve efficiencies for lot disposition and release, reduce cost, and increase customer satisfaction.
Technical Duties/Responsibilities & Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Collaborate with internal and external customers to prioritize GMP document review schedule
Coordinate scheduling of formulation in-process sample testing with cross-functional organizations to ensure timely receipt of results for formulation release
Facilitate submission of reviewed formulation BPRs with Quality Assurance and coordinate release of formulations for production use
Facilitate and coordinate submission of reviewed operation BPRs with Quality Assurance to ensure lot disposition and release timelines are maintained
Perform real-time review of in-progress formulation and operation BPRs within the GMP production suites
Must be able to fully gown into ISO 8 (Class 100K) and ISO 7 (Class 10K) GMP production suites to perform real-time review of BPRs
Supervision Received:
The Manufacturing Specialist receives minimal supervision from the Sr. Manufacturing Manager and/or area supervisor/manager and may perform routine duties with minimal supervision.
Position Type/Expected Hours of Work:
This role is a full-time exempt position with flexible scheduling due to operations/scheduling. The incumbent may be required to work weekends as necessary.
Education and/or Experience:
A Bachelor's degree in life sciences or engineering is required.
Biopharmaceutical experience is required - the incumbent may possess 3 to 5 years technical experience in industry or in graduate level studies. 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 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.
The successful incumbent is meticulous and detail oriented.
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|
|
nasdaq:cdmo
|
avidbio.applicantpro.com
|
avidbio.applicantpro.com
|
Jan 19th, 2019 12:00AM
|
**General Avid Application**
|
Open
|
Avid Bioservices
|
OTHER
|
|
|
CA
|
USA
|
Jan 1st, 2019 12:00AM
|
|
Want to be part of the Avid Bioservices, Inc. team, but don't see a current job posting that you are qualified for or interested in? Feel free to upload your resume using our General Application and state which department(s) you are interested in joining! We will keep your application in order to reach out to you should a new position open in the future that aligns with your background, experience and future career path.
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.
|
|
|
|
|
Jan 18th, 2019 10:21PM
|
Jan 18th, 2019 10:21PM
|
Avid Bioservices
|
|
|