The Senior Director of Biologics Analytical Technologies (BAT) leads groups of scientists engaged in GxP (QC Biochemistry, Stability, Analytical Outsourcing) and non-GxP (Analytical Development) activities supporting the development, optimization, and characterization of analytical methods used for release and stability of biologic materials for use in Preclinical through Phase III clinical development at the Biologics Pilot Plant as well as through Phase III/licensure by management of technology transfer to external CMOs/CROs/CLOs and partners. The Senior Director ensures phase-appropriate assay development requirements as programs progress through the stages of biologics drug development with a line of site towards development of assays which will be robust, reproducible and capable of being qualified and validated for GMP use, for commercial products.The Sr. Director utilizes internal and external networks, and leverages extensive prior relevant experience to create an effective and efficient organization that is recognized for successfully bringing outstanding analytical science to bear on advancing Company's biopharmaceutical programs. The Sr. Director additionally contributes as part of a broader leadership team (BPD, PST), assisting with Biopharmaceutical Development program review and assessment, as well as helping to set and achieve site objectives that cross organizational lines. The Sr. Director takes a leadership role in setting strategic directions, assessing, and ensuring that technical capabilities remain focused and current. The Sr. Director collaborates across domains, functions, and PST.The Sr. Director sets strategic directions and project priorities, providing scientific leadership and oversight, and managing individual performance and cost center budgets. The individual recruits staff as necessary, and mentors, coaches, and develops staff to maximize individual potential, and to grow and retain scientific talent.Essential FunctionsProvide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. (25%) Works through and with others in the global organization, including IPTs, CMC teams, global scientific leads, and other program contributors across Company sites to share expertise, ensure optimum decision making, facilitate smooth information exchange, and help drive progress in biopharmaceutical programs. Interact similarly with external partners and collaborators, as appropriate. (20%) Responsible for comparability and structure activity relationship studies. Oversight of other areas within the organization may be added at the company's discretion. (15%) Establish scientific objectives, review progress, suggest avenues of pursuit, design studies, analyze and report significant results. (10%) Lead and provide day-to-day management of Biologics Analytical Technologies group. Recruit, coach, mentor, develop and retain scientific staff, setting goals and managing performance. (10%) Provide strategic vision, sets priorities, develops annual and biennial objectives, creates and maintains annual operating and capital budgets, and creates organizational structures and associated staffing plans. (10%) Understand and contribute to biopharmaceutical regulatory strategy. Author scientific regulatory submission documents and review sections of regulatory documents written by others. Interact with regulatory agencies directly or through correspondence; author responses to Agency comments. (5%) Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines. (5%) Requirements
- PhD with 15 yrs or MS with 20 yrs experience in scientific leadership positions, including significant work experience in protein biochemical analysis, cGMP Quality Control, and analytical development in an FDA-regulated industry.
- Demonstrated ability to build effective scientific organizations, establish trust with scientific professionals, and build cohesive teams.
- Experience in managing staff.
- Experience in technologies utilized in biopharmaceutical analysis, including HPLC, capillary electrophoresis, ELISA, gel-based assays and other relevant assay technologies used with recombinant proteins; demonstrated expertise in specialized techniques, such as peptide mapping with LCMS or cell-based assays.
- Exhibits a complete understanding of principles, concepts, and practices in analytical development, QC testing, and characterization of biopharmaceuticals, including a thorough understanding of industry best practices and emerging trends.
- Extensive experience, knowledge, and expertise in cGMP/ICH/FDA/EMA regulations and guidelines.
- Strong communication and interpersonal skills. Able to write technical and non-technical documents and to summarize and persuasively present technical materials.