Principal Scientist – Large Molecule Commercialization Stability

Job Description

Large Molecule Analytical Validation group within Analytical Research & Development, our company's Research Labs, is seeking a motivated Principal Scientist with technical expertise in developing large molecule commercialization stability strategies. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define stability strategy and to lead a team of scientists in solving complex analytical problems at the interface of manufacturing, analytical, regulatory and quality disciplines to enable commercialization. More specifically, the ideal candidate will be a recognized expert in developing stability strategies. The successful candidate is expected to provide scientific expertise, and creative solutions to complex situations across the portfolio. They will be accountable to inspire and cultivate scientific rigor through implementation of innovative technologies and approaches to enable speed to market.

The ideal candidate will provide technical and scientific oversight to a group of 3-5 individuals, to support the robust large molecule pipeline. In addition, the Principal Scientist will lead authoring/ revisions of Standard Operating Procedures, Stability Guidelines, Templates etc.

Responsibilities include representing the group on product development teams and defining and implementing stability strategy for the large molecule portfolio, liasing with internal and external stakeholders. The candidate will be expected to effectively communicate with collaborating partners, management and governance teams across the organization.

Education Requirements:

• Ph.D. in biological science, biochemistry, molecular biology, cell biology, virology with a minimum of 8 years of relevant biopharmaceutical industry experience OR M.S. with a minimum of 10 years of relevant experience

Required Skills and Experience:

• In-depth knowledge and understanding of molecular attributes and their relevance in stability testing and shelf life determination of biologics, vaccine and/ or device/combination products.

• Strong leadership skills and a passion for mentoring, team spirit with effective organizational and multi-tasking skills.

• Background in Analytical Methodologies with sound scientific understanding of QbD principles and control strategy via stability testing and specifications. Understanding of program changes and stability impact to support comparative stability studies.

• Investigates out of specification stability results, and actively participates on cross-functional investigation teams to determine root cause and corrective actions

• Demonstrated ability to interpret complex experimental designs and detailed data analysis related to establishing stability, including predictive approaches to determine shelf life.

• Experience with digital platforms for stability studies including data management, trending, visualization and consistent documentation.

• Deep working knowledge of regulatory guidance (ICHQ1, ICHQ5, ICHQ6 etc.) and quality standards, with experience authoring and reviewing regulatory submissions …