Senior Scientist in Biologics Cell Culture Commercialization leading late-stage biologics pipeline. Collaborating with global teams to elevate standards in biologics commercialization and manufacturing.
Responsibilities
Deliver robust DS strategies for successful commercialization
Provide technical oversight of cell culture process development, process characterization and regulatory filing activities
Support DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing sites, process validation, second generation process development and health authority licensure
Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing
Champion compliance and safety; promote a culture of diversity, inclusion, and equity
Mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff
Requirements
Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience
OR Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of relevant industry experience
OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge
Expertise in cell culture commercialization and manufacturing operations
Understanding of regulatory requirements
Ability to lead without authority, build trust, and inspire accountability
Ethical, resilient, and committed to excellence
Skilled in risk management, team facilitation, and strategic planning
Experience in commercial manufacturing and CMC development
Exceptional communication and stakeholder engagement skills
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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