The Quality Director will oversee development and implementation of early-phase GMP manufacturing of novel cytotoxic and antibody drug conjugate (ADC) compounds for client's Phase 1-2 clinical trials. Practical knowledge in all aspects of Quality for product development from investigational phase to commercial launch including QC and Process method development, tech transfer, phase appropriate process and Analytical validation, specification determination and CMC submissions is required. Experience working in GMP regulated environment is essential.
This position is deputy to the Vice President of Quality Assurance for Abzena, and will be responsible for the management of Quality Assurance and Quality Control programs at our Bristol, PA site as well as supervising the employees performing this work.
- Oversee GMP compliant manufacturing and QC testing activities with respect to procedures as well as FDA, EU, ICH, and other regulatory expectations and requirements
- Provide Quality support to manufacturing department to make sure phase-appropriate requirements for product development are met
- Lead the technical transfer of test methods to QC lab for release of raw materials, in-process materials, intermediates, APIs and finished products
- Manage the implementation, qualification, validation (when applicable) and transfer of client's product specific methods. Assist in timely writing, editing and review of documents such as Standard Test Methods, Technical Reports and QC SOPs
- Works closely with manufacturing team to ensure proper preparation and submission of comprehensive manufacturing documentation to the clients
- Work closely with Director of Manufacturing to coordinate GMP related activities to make sure that client's time lines are met
- Facilitate coordination between Quality, GMP Production and QC testing groups to help set and meet timelines while maintaining GMP compliance
- Provide support, when needed, to review executed manufacturing batch records and analytical method validation reports for compliance; assure Drug Substance lots were processed per current manufacturing instructions and conform to Quality standards and regulatory guidances
- Lead and manage GMP investigations of product specific deviations, OOS, OOT and corrective actions to ensure compliance and completion within a specified time frame
- Perform problem solving for issues pertaining to GMP production of Phase 1 - 2 Clinical Products
· Carry out batch review to determine disposition of Drug Substance lots for Phase 1 - 2 human clinical trials
· Establish and monitor client's product stability programs
- Review and provide inputs for CMC sections of client's IND and IMPD submissions for Drug Substance, Drug Products and stability studies
- Provide Quality input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the GMP facility and equipment
- Review and approve client specific production batch records and analytical method validation protocols
- Coordinate the writing of client-specific Drug Substance product specifications
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus
- Bachelor's degree in a relevant discipline (e.g., chemistry, biological sciences, pharmacy, etc.)
- Broad knowledge of drug development
- Minimum 10 years of experience in the pharmaceutical industry
- At least six (6) years of Quality -related experience in a current Good Manufacturing Practices (cGMP) environment
- Knowledge of and proficient in FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations
- Ability to manage manufacturing investigations
- Strong leadership and motivational capabilities
- Demonstrated ability to supervise and manage employees
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
- Problem solver who not only identifies issues but leads efforts to resolve them
- Experience of working within both biologics and small-molecule manufacturing Quality environments
- Experience of working with bioconjugates
- Skill in aseptic processing experience with respect to drug product formulation would be an advantage
Abzena is a life sciences group with its headquarters in the UK and two sites in the US. Abzena offers a range of complementary services and technologies for the selection, development and manufacture of biopharmaceuticals, products based on antibodies or other proteins.
Working with companies and academic groups all over the world, including most of the top 20 biopharmaceutical companies, Abzena supports the development and manufacture of better treatments for patients. Eleven antibodies which have been created using Abzena's technologies (ABZENA inside products) are currently being progressed through clinical development by our licensees. More information on our ABZENA inside products is available here.
Abzena was created through the incorporation of Antitope, PacificGMP, PolyTherics, The Chemistry Research Solution (TCRS) and Warwick Effect Polymers, all of which now trade as Abzena.
Role: Director of Quality (QA/QC)
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