Principal Scientist, Late Stage Analytical Program Lead

Job Description

Principal Scientist, Late Stage Analytical Program Lead

About the role

You will join our Large Molecule Analytical Validation team to serve as an Analytical Program  Lead. The lead must take charge in overseeing and guiding analytical strategies, driving the technical execution of large molecule (biologics and vaccine) programs as they progress from development to commercialization as part of the Development and Commercialization Team. The incumbent should apply stage appropriate scientific rigor, ensure adherence to timelines across all workstreams, and proactively mitigate challenges that may arise. The lead will maintain program schedules diligently while escalating any identified risks to ensure smooth progress and successful outcomes.   In this role, you will work closely with cross functional teams within Biologics and Vaccines AR&D, Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory, Quality, and Commercial-facing Partner Groups to support commercialization of our products.

Responsibilities:

• Working with external partners to manage, oversee, take ownership and accountability of all analytical deliverables, including method development, testing, validation, transfer, stability, extended characterization, and formulation workstreams.

• Serve as the primary point of contact for key stakeholders for all Analytical Research and Development (AR&D).

• Develop and implement the analytical strategies for large molecule (biologics and vaccines) programs in a matrix team environment to enable delivery on time.

• Provides multi-disciplinary leadership to the team and is able to foresee emerging issues, drive recommendations through to implementation with an enterprise mindset, and influence others in a matrix organization.

• Drive disciplined decisions in rapidly evolving, complex or ambiguous situations and effectively represent these decisions across functional areas and governances.

• Provides guidance and support to the team in troubleshooting analytical issues and resolving conflicts.

• Coordinate and facilitate the development, optimization, and validation lifecycle activities of analytical methods.

• Support Quality by Design (QbD) activities and lead discussions on process and analytical risk assessment.

• Proactively initiate technical reviews within AR&D and serve as the Analytical representative on governance interactions and stage-gate reviews.

• Develop and maintain a central repository for knowledge and life-cycle management of the program to support regulatory filings.

Required Experience and Skills:

• Extensive experience in analysis of biologics and vaccines encompassing all types of analytical methods.

• Strong background in analytical and integrated control strategy development and execution with a sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications

• Experience in establishing phase appropriate specifications, justifying specifications as governance, and authoring source documents to support filings

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Actively develops high performing teams

• Ability to design, execute and/or direct the development, validation and transfer of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development

• Proficient in the development of comparability strategies to enable agency acceptance

• Experience in the design of stability studies to maximize product shelf life claim including combination products

Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or a related field with at least 14 years of relevant experience. Alternatively, a Master's degree with 10 years of relevant experience or a Ph.D. with 8 years of relevant experience.

• Possess a deep technical expertise within analytical on biochemical, biophysical, and biological activity-based assays for large molecules with demonstrated ability to support new product development and commercialization.

• Understands connectivity between cross functional partners to support pipeline progression

• Strong knowledge of large molecule CMC requirements and experience in supporting health authority filings.

• Effective communication and leadership skills in a dynamic environment.

• Project management experience, including tracking, supporti