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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in biologic production processes, particularly in polysaccharides and glycoconjugate vaccines, while effectively leading cross-functional teams to ensure successful commercialization and regulatory compliance. Strong capabilities in strategic planning, problem-solving, and communication are essential for driving technical milestones and optimizing operations.
Highest-signal resume keywords
Biologic Production ProcessesPolysaccharidesGlycoconjugate VaccinesLeadership in MSATRegulatory Filings
About the role
Key responsibilities & impact- Lead assigned commercialization workstreams and facilitate launch readiness and commercial supply of polysaccharides used in glycoconjugate vaccines
- Lead technical launch planning and execution for regulatory filings, facility readiness, and launch supplies
- Coordinate cross-functional efforts across Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering
- Translate commercialization strategy into execution plans and ensure key technical milestones are completed
- Develop technical capabilities and support resource and staffing recommendations
- Improve process understanding and robustness by monitoring, trending, and optimizing operations
- Identify, communicate, and escalate technical and supply risks
- Provide technical oversight for technology transfers, new technologies, internal and external manufacturing sites, and CMOs
- Lead process validation and comparability activities
- Review and author regulatory filings and respond to health-authority questions
- Communicate process performance and the scientific and commercial rationale for polysaccharide processes to internal and external stakeholders
- Lead assigned polysaccharide commercialization programs and technical workstreams
- Report to the Senior Director, Global Polysaccharide Commercialization Lead
- Travel 10-30%
Requirements
What you’ll need- Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A., or 16+ years for B.S./B.A.
- Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales
- Experience with polysaccharides and glycoconjugate vaccines highly preferred
- Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles
- Deep technical knowledge applied collaboratively to establish strategic plans and achieve collective goals
- Excellent organization, problem solving and strategic planning skills
- Highly skilled in verbal and written communication, with ability to interact effectively with people of diverse backgrounds and perspectives
- Ability to recognize needs and challenges and implement effective solutions
- Ability to seek and analyze data from varied sources to support decisions and align others with organizational strategy
- Entrepreneurial and creative approach to developing innovative ideas
- 10-30% travel required
Benefits
Comp & perks- Comprehensive benefits
- Equity component
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Bacterial FermentationRecovery and PurificationProcess ValidationTechnical OversightData Analysis
Soft Skills
Excellent OrganizationProblem SolvingStrategic PlanningVerbal CommunicationWritten Communication
Industry Keywords
Commercialization StrategyCross-Functional CoordinationTechnical Launch PlanningSupply Chain ManagementProcess Engineering