Assoc Prin. Scientist, Engineering

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We are seeking a strategic and technical leader with expertise in cell culture development & commercialization to spearhead our ever‑growing late‑stage biologics pipeline within the expansive Biologics S&T portfolio.

As a Biologics Cell Culture 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 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. Your work will shape the future of biologics on a global scale.

• Technical Strategy:
  Deliver robust DS strategies for commercialization and oversee cell culture process development, characterization, and regulatory filing activities.
• Technical Leadership:
  Provide expertise in mammalian cell culture processing, oversee planning, execution, analysis, and documentation of all stages of cell culture process commercialization.
• CMC RA:
  Support/writing regulatory filings (IND, MAA, BLA) and inspections with agencies (FDA, EMA, JNDA, TGA).
• Leadership:
  Establish, manage, and mentor a team of scientists.
• Cross‑Functional
  
  Collaboration:
  
  Unite diverse teams to achieve program goals and promote a culture of diversity, inclusion, and equity.
• Problem Solving:
  Remove roadblocks, resolve conflicts, and escalate issues.
• Communication:
  Foster collaboration, ensure transparency, and engage with governance bodies.
• Project Management:
  Drive project schedules, set priorities, and monitor performance metrics.
• Recognition:
  Celebrate team achievements and foster a culture of appreciation.
• Innovation:
  Lead business improvement initiatives.

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with 8 years of relevant industry experience.
• Master’s degree in same fields with 6 years of relevant industry experience.
• Ph.D. in same fields with minimum 3 years of relevant industry experience.

• Proven leadership of 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.

Accountability, Adaptability, Bioprocessing, Cell Cultures, Chemical Engineering, Cross‑Functional Teamwork, Data Analysis, Decision Making, Detail‑Oriented, Innovation, Mammalian Cell Culture, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale‑Up, Mentorship, Process Improvements, Project Management, Regulatory Submissions, Risk Management, Stakeholder Engagement, Technical Leadership, Technical Writing, Technology Transfer.

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities.

Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid schedule: three on‑site days per week and one remote day. This model does not apply to field‑based or manufacturing‑based positions and others specified.

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We offer a comprehensive package of benefits: medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate and sick days. Detailed benefits information is available at

You can apply for this role through  or via the Workday Jobs Hub if you are a current employee. The Final date to receive applications is stated on this posting.