Senior Scientist, Cell Culture Sciences, Biologics Drug Substance Commercialization

Overview

Join Our Team as a Biologics Cell Culture Senior Scientist!

Are you ready to take your career to the next level? We are seeking a strategic and technical scientist with expertise in cell culture development & commercialization to spearhead our late-stage biologics pipeline within the Biologics S&T portfolio.

Why You ll Love This Role:

As a Sr. Scientist in Biologics Cell Culture Commercialization, you ll provide strategic and tactical technical direction through cross-functional partnerships with key business units and customers. You ll 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. You ll help transform our late-stage pipeline into reality and bring lifesaving medicines to patients worldwide.

Global Impact:

Collaborate with colleagues across the US and internationally to elevate standards in biologics commercialization and manufacturing. Your work will shape the future of biologics on a global scale.

• Technical Strategy: Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth path to successful PPQs and BLAs for the pipeline.

• Technical knowledge: Fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products). Independently plan, execute, analyze, and document all stages of cell culture process commercialization. Include risk assessment, control strategies, process comparability reports, PPQ, and regulatory submissions.

• CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).

• Leadership: Support Cell Culture CMC teams and align resources to deliver on priorities. Mentor scientists in biologics commercialization; act as scientific/technical mentor for junior staff. Demonstrate action-oriented mindset, initiative, innovation, iteration, and problem-solving.

• Cross-Functional Collaboration: Unite diverse teams to achieve program goals. Champion compliance and safety; promote diversity, inclusion, and equity. Experience collaborating in internal and external matrixed teams.

• Problem Solving: Remove roadblocks, resolve conflicts, and escalate issues when needed.

• Communication: Foster collaboration, ensure transparency, and engage with governance bodies. Excellent interpersonal and communication skills.

• Project Management: Adaptability and agility to prioritize and deliver complex objectives on tight timelines in a rapidly changing environment.

• Recognition: Celebrate team achievements and foster a culture of appreciation.

• Innovation: Lead business improvement initiatives and leverage your network to drive change.

• Bachelor s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with six (6) years of relevant industry experience. OR

• Master 's degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with four (4) years of relevant industry experience. OR

• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or related field with 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

If you  passionate about biologics and ready to lead a high-impact team, apply now and be part of a transformative journey in DS commercialization and biomanufacturing.

Required Skills: Biological Engineering, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering,…