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Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Salary Salary Currency Salary Description Coordinates Date Added Date Updated Company Name Sector Industry
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 6th, 2018 12:00AM Scientist - Biologics Manufacturing Open Manufacturing Cleveland OH USA Conducts GMP manufacturing for clinical and/or commercial purposes in diverse biological areas and for a variety of products. Skilled in GMP operations, principles and practices. Relies on extensive experience and judgment to plan, execute and accomplish goals.  Responsibilities: Initiates, plans, and executes all aspects of GMP operations for a process (or process in qualification or validation) Identifies and evaluates new scientific approaches or methods to improve the products/processes of Abeona Serves as an internal manufacturing consultant, advises management on manufacturing issuesInterfaces with others on multidisciplinary teams for planning, implementation, analyses and problem solving  Represents the company at external manufacturing/scientific conferences Qualifications: Bachelors degree in science and 8 or more years relevant experience, or Masters degree in science and 5 or more years relevant experience, or PhD in science with 2 to 5 years relevant experience Demonstrates ability to lead and teach Senior Manufacturing Associates and lower level employees as appropriate. Jul 6th, 2018 04:48PM Jul 6th, 2018 05:07PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 6th, 2018 12:00AM Director of Quality Control - Biologics Open Quality Assurance Cleveland OH USA Position Overview The Director Quality Control (QC) will lead QC activities associated with the GMP production. Such products include Adeno-associated Viral Vectors (AAV) and Retroviral Cell Therapy Vectors. This position will oversee the operation of the QC Biochemistry, Stability, Bioassay, Microbiology, and Raw Material functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring and overall support for clinical and commercial product manufacturing. The successful candidate will be responsible for also overseeing QC activities at the Abeona’s designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). Responsibilities Implement and manage a GMP compliant laboratory control program in adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods, validation and stability Planning and execution of QC testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete Responsibility for release testing of raw materials, process intermediates, packaging components, and drug products Maintain and trend environmental monitoring and personnel monitoring programs to ensure compliance to regulatory requirements Support CMO production activities by coordinating testing activities with appropriate external and in-house departments Support in-house production by co-ordination of in-process QC testing, environmental monitoring, and release/characterization testing with appropriate departments/CTOs Prepare specifications and Certificates of Analysis (COA) for QA review Establish and execute stability programs for raw materials, cell and viral banks, drug substances and drug products Coordinate with the Analytical Methods Development group the phase appropriate qualification/ validation of analytical procedures, the transfer of such procedures into QC, and the setting of appropriate acceptance criteria Manage the development, validation, and approval of all microbiology, and raw materials test methods used in production operations as well as Assay Transfer with external customers or CMO/CTOs Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs Draft and review of SOPs, records/forms and protocols for in-house QC testing and overall QC operations Assist in the preparation of CMC regulatory submissions Interact with the FDA and other worldwide regulatory agencies, per product filings (IND, BLA MAA etc.), regarding any questions relating to microbiology, biochemistry, chemistry and stability testing Conduct investigations into atypical and out-of-specification test results internally and externally Requirements A minimum of Bachelor’s in Biological Sciences, Bioengineering or Chemistry Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on analytical QC for biologic products Minimum of 5 years demonstrated track record of leadership and management of QC groups with people development and performance management skills In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic product testing and method validation Experience managing CMO/CTO relationships preferred Deep knowledge of FDA, ICH and USP/European Pharmacopeia requirements Excellent interpersonal, organizational, and written/oral communication skills Jul 6th, 2018 04:48PM Jul 6th, 2018 05:07PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 6th, 2018 12:00AM Biostatistician - Clinical Trials Design Open Executive Cleveland OH USA Position Overview The Biostatistician brings statistical expertise to the design, conduct, analysis and reporting of clinical studies. The Biostatistician works as a member of a cross-functional clinical / regulatory team and continuously strives to ensure timely delivery and scientific validity of results Responsibilities Provide statistical input to study protocols for design and analysis of clinical and laboratory trials, randomizations, sample size calculations to determine power, and statistical analyses. Prepares statistical analysis plans (SAPs), designs shells for tables, listings and figures and performs statistical analysis. Contributes to the preparation and completion of clinical trial study documents including, but not limited to, study protocols, project specification plans, data management plans and clinical study reports. Assists with the preparation of manuscripts and writes reports describing results of statistical analysis. Represents the Biostatistics function in project team meetings. Consults with Product Development Team, Clinical Operations, and Quality/Manufacturing on laboratory and clinical trial or statistical issues, to bring rigorous statistical analysis to bear in making technical and business decisions. Provides consultation as needed on statistical method, questionnaire construction, and data gathering techniques. Interfaces with project management, functional team members and investigators to ensure a timely, precise and accurate laboratory/clinical data reporting process. Conducts all job duties within context of Good Clinical Practice (GCP) and according to company SOPs and applicable ICH/EMEA guidelines. Support project teams in study design and statistical analysis as well as communicate and interact with project team members and clients Provide statistical input on clinical electronic data capture (EDC) design and edit checks Provide statistical input for the design, writing and review of study protocols, including the design of studies and sample size/power estimations and the development and review of statistical analysis plans (SAPs) Utilize SAS for programming for validation, analysis, and reporting of clinical data (proficiency in other statistical or programming languages e.g. R, Python is welcome) Analyze data for, and prepare and review interim study reports, manuscripts, abstracts, and grants Effectively communicate statistical issues to project team members Requirements Master’s or Ph.D. degree in biostatistics or related field Minimum of 5+ years of experience in the analysis of data for clinical trials Proficient in SAS programming for statistical analysis and data manipulations is essential; Ability to understand and interpret complex mathematical/statistical problems. Strong understanding of the product development process from design and inception to data acquisition to data reporting. Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact and communicate with staff and management alike. Proficient with Microsoft Outlook, Word, and Excel. Impeccable attention to detail Excellent analytical, organizational, and communication skills Demonstrated leadership ability Ability to work successfully with minimal supervision Jul 6th, 2018 04:48PM Jul 6th, 2018 05:07PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 6th, 2018 12:00AM Quality Assurance Specialist - Supplier / Material Management Open Quality Assurance Cleveland OH USA The Quality Assurance Specialist / Manager performs routine activities associated with the Supplier and Material Management programs in support of a cGMP Operation.  Requirements: Leads and conducts supplier and service provider audits. This includes providers for clinical and operational activities. Includes risk assessments, scheduling, preparing documents prior to the audit, and managing audits. Leads supplier qualification activities and monitors supplier/service provider performance. Collaborates and approves raw material and packaging component specifications. Reviews and approves supplier change requests. Initiates Supplier Corrective Action request. Supports Supplier Quality Management initiatives. Coordinates and responds to Supplier Audit Responses. Leads discussions on observations with management on audit corrective actions and responses.  Leads audit teams in resolving supplier qualification and/or disqualification actions. Prepares and maintains Vendor or Supplier Audit Plan. Works with purchasing to address Supplier Notifications of Change(s). Reviews, tracks and approves supplier change requests. Manages the quality agreement program and life cycle. Leads and/or performs internal QA Compliance audits Trains site personnel on auditing and audit readiness. Writes and maintains supplier management SOPs as needed. Works with R&D on new product or technology transfer product audits. Provides oversight for the medical device QMS and CMO quality relationship for MuGard®. Supports Regulatory Authority Compliance audits Performs other related job duties as required. Qualifications: Five (5) or more years related experience in a pHarmaceutical GMP regulated manufacturing environment. Two (2) or emore years experience performing audits (internal or external). Strong ability to interpret technical procedures, SOPs, and regulatory regulations Quality or compliance certification (ASQ CQA or CQE) preferred. Strong ability to compose clear and concise communications with an astute attention to detail. Must possess professionalism and ability to effectively interact and communicate with internal staff and management as well as with external service providers and suppliers. Able to learn new computer systems / programs quickly Excellent organizational skills and attention to detail Bachelor’s of Science degree or equivalent. Travel up to 25% of the time. Jul 6th, 2018 04:48PM Jul 6th, 2018 05:07PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 6th, 2018 12:00AM Quality Control Associate - Bioassay Testing Open Quality Control Cleveland OH USA The Quality Control Associate performs routine laboratory activities in support of GMP testing for Quality Control. Testing includes raw material, packaging components, in-process and finished product. Interacts with analysts internal and external to Quality Control. Requirements Works on QC tasks of more diverse scope, requiring regular analysis and evaluation of data. Demonstrated strong understanding of QC principles and GMPs. Technical understanding of assays (bio, molecular, and/or analytical) and performs testing in support of raw materials, in-process samples and finished product analysis. Consistently performs and troubleshoots own assays or procedures. Perform validation/qualification of methods transferred into the QC laboratory. Provides input to improving QC systems and procedures to improve GMP. Complies with company documentation practices (GDP). Provide technical expertise in Quality Control for release and stability testing of clinical and commercial products. Reviews specifications for raw material, packaging components, drug products, and reference standards. Review of analytical methods, SOPs, test records, and CofAs Authors/reviews the batch analysis, stability and reference standard sections of regulatory submissions (CTA/ IND or NDA/BLA). Supports laboratory investigations related to test failures, discrepancies and deviations. Supports release testing at external service providers. Supports maintaining laboratory in inspection readiness state. Requirements BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with up to 4 years of relevant experience. Experience in Western Blot, ELISA, cell culture and cell based potency assays preferred. Experience performing USP testing. Strong understanding of basic scientific concepts in one or more areas. Experience with relevant analytical lab equipment and computers. Ability to understand analytical/technical data. Good mathematical skills. Good organizational skills and attention to detail Ability to interact constructively with co-workers Jul 6th, 2018 04:48PM Jul 6th, 2018 05:07PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 6th, 2018 12:00AM QC Associate - Biologics Open Quality Control Cleveland OH USA This position is responsible for QC Lab GLP Assay execution in support of clinical product development and /or commercial product manufacture. This includes in process and lot release assays and qualifications and validations of said assays. Also performs internal facility environmental assays to confirm the facility is under control and within specifications. Coordinate all metrology testing whether performed in house or by a third party. Responsibilities: Performs GLP assays for which they documented training Writes detailed reports making detailed observations, analyses, data interpretations and conclusions Helps to develop qualification and/or validation protocols Cross-trains others on scientific techniques, validation methods, etc. Maintains ongoing training/education by attending internal training sessions, workshops, external meetings ​Qualifications: Bachelor’s degree in biology, chemistry, engineering or related field. 2 or 4 or more years relevant experience. Demonstrates ability to plan / execute assays or experiments to address technical problems or to  advance a project Jul 6th, 2018 04:48PM Jul 6th, 2018 05:07PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 8th, 2018 12:00AM Quality Control Associate - Bioassay Testing Open Quality Control Cleveland OH USA The Quality Control Associate performs routine laboratory activities in support of GMP testing for Quality Control. Testing includes raw material, packaging components, in-process and finished product. Interacts with analysts internal and external to Quality Control. Requirements Works on QC tasks of more diverse scope, requiring regular analysis and evaluation of data. Demonstrated strong understanding of QC principles and GMPs. Technical understanding of assays (bio, molecular, and/or analytical) and performs testing in support of raw materials, in-process samples and finished product analysis. Consistently performs and troubleshoots own assays or procedures. Perform validation/qualification of methods transferred into the QC laboratory. Provides input to improving QC systems and procedures to improve GMP. Complies with company documentation practices (GDP). Provide technical expertise in Quality Control for release and stability testing of clinical and commercial products. Reviews specifications for raw material, packaging components, drug products, and reference standards. Review of analytical methods, SOPs, test records, and CofAs Authors/reviews the batch analysis, stability and reference standard sections of regulatory submissions (CTA/ IND or NDA/BLA). Supports laboratory investigations related to test failures, discrepancies and deviations. Supports release testing at external service providers. Supports maintaining laboratory in inspection readiness state. Requirements BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with up to 4 years of relevant experience. Experience in Western Blot, ELISA, cell culture and cell based potency assays preferred. Experience performing USP testing. Strong understanding of basic scientific concepts in one or more areas. Experience with relevant analytical lab equipment and computers. Ability to understand analytical/technical data. Good mathematical skills. Good organizational skills and attention to detail Ability to interact constructively with co-workers Jul 7th, 2018 10:04PM Jul 7th, 2018 10:04PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 8th, 2018 12:00AM Assay Development - Biologics - Protein Characterization / Immunology Open Quality Control Cleveland OH USA This position is a key part of our growing QC Team and will be primarily responsible for Environmental Monitoring in support of clinical product development and / or commercial product manufacturing.  You will perform in-process and product release assays in a GMP/GLP QC environment. Responsibilities: Help develop, optimize, and qualify or validate analytical methods for routine and non-routine Quality Control analysis of finished formulations, in-process samples, and raw materials in compliance with FDA/GMP/GLP regulations and all operational procedures. Assist with implementing new methodologies and instrumentation, writing SOPs, drafting and executing qualification or validation protocols, and technical transfer of assays in the QC laboratory. Follow good documentation practices in all aspects and phases of the work. Provide data, results, summaries, and reports for review in a timely manner Work with other lab personnel on projects and participate in OOS and failure investigations. Help maintain the equipment, safety, and orderliness of the lab. ​Qualifications: BS or BA in Microbiology or Biological sciences and a minimum of 3-5 years of basic laboratory experience  Experienced and knowledgeable in the pharmaceutical and/or biotech industry with techniques including ELISA, Western Blots, SDS-PAGE, IEF, various protein chromatography and immunocytochemistry Must be able to perform identity, potency, and safety assays for in-process and release of commercial and clinical grade products Experienced in both GLP and GMP working environments and their regulations Must be familiar with basic aseptic techniques and requirements  Must be able to lift a minimum of 30 pounds  LIMS (Laboratory Information Management System) experience is preferred, but not required. Jul 7th, 2018 10:04PM Jul 7th, 2018 10:04PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 9th, 2018 12:00AM Director of Quality Control - Biologics Open Quality Assurance Cleveland OH USA Position Overview The Director Quality Control (QC) will lead QC activities associated with the GMP production. Such products include Adeno-associated Viral Vectors (AAV) and Retroviral Cell Therapy Vectors. This position will oversee the operation of the QC Biochemistry, Stability, Bioassay, Microbiology, and Raw Material functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring and overall support for clinical and commercial product manufacturing. The successful candidate will be responsible for also overseeing QC activities at the Abeona’s designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). Responsibilities Implement and manage a GMP compliant laboratory control program in adherence to current FDA Guidelines, ICH, and foreign regulations in the areas of microbiology, biochemistry, chemistry, methods, validation and stability Planning and execution of QC testing to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete Responsibility for release testing of raw materials, process intermediates, packaging components, and drug products Maintain and trend environmental monitoring and personnel monitoring programs to ensure compliance to regulatory requirements Support CMO production activities by coordinating testing activities with appropriate external and in-house departments Support in-house production by co-ordination of in-process QC testing, environmental monitoring, and release/characterization testing with appropriate departments/CTOs Prepare specifications and Certificates of Analysis (COA) for QA review Establish and execute stability programs for raw materials, cell and viral banks, drug substances and drug products Coordinate with the Analytical Methods Development group the phase appropriate qualification/ validation of analytical procedures, the transfer of such procedures into QC, and the setting of appropriate acceptance criteria Manage the development, validation, and approval of all microbiology, and raw materials test methods used in production operations as well as Assay Transfer with external customers or CMO/CTOs Oversee QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs Draft and review of SOPs, records/forms and protocols for in-house QC testing and overall QC operations Assist in the preparation of CMC regulatory submissions Interact with the FDA and other worldwide regulatory agencies, per product filings (IND, BLA MAA etc.), regarding any questions relating to microbiology, biochemistry, chemistry and stability testing Conduct investigations into atypical and out-of-specification test results internally and externally Requirements A minimum of Bachelor’s in Biological Sciences, Bioengineering or Chemistry Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on analytical QC for biologic products Minimum of 5 years demonstrated track record of leadership and management of QC groups with people development and performance management skills In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic product testing and method validation Experience managing CMO/CTO relationships preferred Deep knowledge of FDA, ICH and USP/European Pharmacopeia requirements Excellent interpersonal, organizational, and written/oral communication skills Jul 8th, 2018 10:04PM Jul 8th, 2018 10:04PM Abeona Therapeutics
nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Jul 9th, 2018 12:00AM QC Associate - Biologics Open Quality Control Cleveland OH USA This position is responsible for QC Lab GLP Assay execution in support of clinical product development and /or commercial product manufacture. This includes in process and lot release assays and qualifications and validations of said assays. Also performs internal facility environmental assays to confirm the facility is under control and within specifications. Coordinate all metrology testing whether performed in house or by a third party. Responsibilities: Performs GLP assays for which they documented training Writes detailed reports making detailed observations, analyses, data interpretations and conclusions Helps to develop qualification and/or validation protocols Cross-trains others on scientific techniques, validation methods, etc. Maintains ongoing training/education by attending internal training sessions, workshops, external meetings ​Qualifications: Bachelor’s degree in biology, chemistry, engineering or related field. 2 or 4 or more years relevant experience. Demonstrates ability to plan / execute assays or experiments to address technical problems or to  advance a project Jul 8th, 2018 10:04PM Jul 8th, 2018 10:04PM Abeona Therapeutics

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