Astellas Pharma Associate Director, Analytical Development, Cell Therapy in Westborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.
Astellas is announcing an Associate Director, Analytical Development, Cell Therapy opportunity at their affiliate Astellas Institute of Regenerative Medicine (AIRM) in Westborough, MA.
We are looking for a highly motivated and technically proficient individual to join our team and contribute to and advance the development of cell therapy products. This individual will coordinate analytical quality control strategy for pipeline programs, including leading analytical development/testing throughout the product life cycle. This position will collaborate closely within the team and across functional groups (R&D/CMC TO/GMP TO) to advance multiple internal and external programs.
Essential Job Responsibilities:
- Develop analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies and release/stability criteria for various scenarios including accelerated product development
- Support all CMC filing activities for various pre-INDs, INDs, IMPDs, and BLAs and track analytical development /QC commitments
- Actively participate in CMC regulatory writing activities for analytical development function, assist in review of regulatory filings in INDs/IMPDs, and BLAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements
- Lead tech transfer of methods to QC testing facility and to CRO/CMO's. Manage and oversee analytical activities performed at CROs/CDMOs associated with method development and characterization for drug substance, drug product and reference standards
- Develop and establish the strategies for product characterization with a focus on CQA assessment, comparability and lead characterization activities
- Collaborate with upstream and downstream process and formulation functions to ensure strong cross functional collaborations and integrated process and product development and characterization
- Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.)
- Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards
- Establish and implement processes to enable effective collaboration with CRO/CMO business partners to ensure efficiency and high quality of results
- PhD. in chemistry, biology, biochemistry, molecular biology or related technical discipline with a minimum of 8-10 years of biopharmaceutical analytical experience or Masters in a similar discipline with 12-15 years of the previously mentioned experience
- Significant and established experience in the biopharmaceutical industry with relevant experience in product and process characterization for cell/gene-based therapies
- Demonstrated experience and knowledge in tech transfer of methods and life cycle management
- Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization including cell culture techniques, HPLC based separation methods, Immuno-histochemistry, Flow cytometry, gene expression assays, Bioassays, in vitro potency and other physicochemical technologies
- Provide leadership in developing assays for various process streams, evaluating matrix effects and material storage
- Conduct testing, train analysts, analyze data, and review results
- Keep current with advances in analytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing process and product understanding
- Willing to work and assist/train other staff at the bench level
- Collaborate with QC to transfer and/or qualify key in-process methods or release methods
- Operate under Good Documentation Practice for efficient data management and retrieval
- Generate technical documentation, including assay development reports and testing plans
- Support investigations and CAPAs as required
- Interact closely with multiple interdisciplinary groups (MFG, QA, QC, IT, Process Science Technology, Process Development, Facilities, etc.)
- Strong communication skills: ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience
- Proven ability to work with at a high level of integrity, accuracy, and attention to detail
- Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions
- Support tech transfer activities if required
- Resourceful, enthusiastic, and results-oriented
- Advanced degree/education
- Strong experience/proficiency in ocular, immunomodulatory, or other disease states.
- Background in iPSC and hESC cell line derivation, in particular hematopoietic cells
- Experience with assay qualification/validation and/or cell therapy products
- Knowledge of GMP, ICH, USP, JP, EU and global compendial regulations
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Manufacturing & Operations