Principal Scientist, Engineering

Biologics Drug Substance Commercialization Leader

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

As a Biologics Drug Substance commercialization Leader, you’ll be at the forefront of scientific advancement, providing strategic and tactical technical direction through cross‑functional partnerships with key business units and customers. Your leadership will be instrumental in supporting 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 lead the charge in transforming our late‑stage pipeline into reality, bringing lifesaving medicines to our patients worldwide.

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 and provide technical oversight of cell culture process development, process characterization, and regulatory filing activities to ensure a smooth path to successful PPQs and BLAs.
• Technical Leadership:
  Apply deep knowledge of mammalian cell culture processing, including recent advances and field challenges; independently conduct and direct planning, execution, analysis, and documentation of all stages of cell culture process commercialization.
• CMC RA:
  Support or write regulatory filings (IND, MAA, BLA) and inspections with FDA, EMA, JNDA, TGA.
• Leadership:
  Establish, manage, and support CMC teams, align resources to deliver on priorities, mentor scientists, and foster a culture of creativity and initiative.
• Cross‑Functional
  
  Collaboration:
  
  Unite diverse teams to achieve program goals as One Team and champion compliance, safety, diversity, inclusion, and equity.
• Problem Solving:
  Remove roadblocks, resolve conflicts, and elevate issues when needed.
• Communication:
  Foster collaboration, ensure transparency, and engage governance bodies with excellent interpersonal skills.
• Project Management:
  Drive project schedules, set priorities, and monitor performance metrics, adapting to tight timelines and rapid change.
• 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 a related field with sixteen (16) years of relevant industry experience.
• Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with twelve (12) years of relevant industry experience.
• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a minimum of eight (8) years of relevant industry experience.

• Proven leadership of cross‑functional teams in biologics development & commercialization.
• Deep expertise in cell culture commercialization and manufacturing operations.
• Strong 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.

• Cell Cultures, Chemical Engineering, Clinical Manufacturing, Commercialization, Communication, Creativity, Cross‑Functional Collaboration, Cross‑Functional Teamwork, Decision Making, Driving Continuous Improvement, Mammalian Cell, Mammalian Cell Culture, Manufacturing Scale‑Up, Mentorship, Process Characterization, Process Control, Process Design, Process Optimization, Regulatory Submissions, Risk Management,…