Principal Scientist, Chemistry

Job Description

The Global Vaccines and Biologics Commercialization (GVBC) team within our Company Manufacturing Division is dedicated to the late-stage process development, technology transfer, and ongoing support of large molecule products, including vaccines and biologic therapeutics. Our mission is to ensure a compliant and cost-effective supply of our top-tier inventions to patients through technical excellence. We support manufacturing sites by commercializing our pipeline and offering technical assistance in the production, testing, and release of our products.

As a member of the Process Attribute Sciences (PAS) team, you will join a dynamic and inclusive group of expert scientists and engineers. Under the general scientific and administrative direction of the Director in ComPAS, this individual will lead and oversee the advancement of Process Analytical Technology (PAT) in GVBC. We are seeking a highly skilled and innovative Principal Scientist to be responsible for development, optimization, and implementation of new in-line, on-line and at-line analytical technology to support biologics and vaccine process understanding in the our Company Manufacturing Division. The ideal candidate will possess experience in people management and cross-functional collaboration. The individual will manage a team of PAS scientists and will ensure that GVBC delivers an outstanding level of rigor in our scientific work and commercialization support activities.

You will have the opportunity to collaborate with GVBC teams, Large Molecule Technical Operations (LMTO), and Research Division partners to implement PAT platforms that enhance manufacturing capabilities in our commercialization and in-line product manufacturing facilities. You will also be responsible for developing regulatory strategies to secure global acceptance of innovative control strategies that will be filed with our portfolio of large molecule products. Your contributions will include the development and implementation of advanced real-time technologies to support new product development and process control applications in manufacturing, helping our Company achieve its World Class Supply objectives.

Job role expectations:

• Leadership in PAT deployment: Lead the systematic assessment and deployment of in-line, on-line, and at-line PAT methods across upstream cell culture, fermentation, purification, and drug product operations for our large molecule pipeline and in-line programs.

• Lead a team of 3-5 scientists/engineers in execution of PAT projects across the large molecule commercialization and in-line product portfolio.

• Design and develop standard analytical platforms aimed at enabling PAT, including but not limited to in-line/on-line monitoring and rapid shop floor analytics

• Lead the effort to develop innovative PAT solutions for new product modalities including antibody drug conjugates (ADC’s), peptides, and multi-specific antibody therapeutics

• Manage PAT scale-up and technology transfer to large scale manufacturing.

• Create and implement integrated control strategies based on PAT platforms to facilitate both batch and continuous manufacturing

• Collaborate with new facility capital project teams to design and establish integrated PAT infrastructure, ensuring alignment with the strategic vision of next-generation manufacturing platforms.

• Drive division wide PAT initiatives that will enable our Company’s vaccine/biologics manufacturing strategic goals.

• Mentor and support the professional development of direct reports

• Foster a culture of innovation and technical excellence within the team.

Education Guideline:

• M.S. or higher in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with 12+ years of relevant industry experience.

• Ph. D with 8 years’ experience

Required Experience and Skills:

• PAT experience

• A record of relevant publications

Preferred Experience and Skills:

• Regulatory filing experience regarding PAT

• Strong experience in managing cross-functional teams and projects, with excellent interpersonal and people management skills.

• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.

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