Director, Cell Banking Leader

Job Description

Join Our Team as a Biologics Drug Substance & Cell Banking Leader!

Are you ready to take your career to the next level We are seeking a dynamic and visionaryBiologics Drug Substance & Cell Banking Leaderto spearhead our cutting-edge cell banking and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader you will lead the Cell Banking working groups and drive innovation in biologics DS & cell bank manufacturing and commercialization projects.

Why Youll Love This Role:

As the Biologics Drug Substance & Cell Banking Leader youll 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 & cell bank commercialization tech transfer manufacturing qualifications licensure and the launch of new DS & cell bank manufacturing sites. Youll build the foundation for long-term robust manufacturing enhance data monitoring capabilities and drive excellence in safety compliance supply and productivity.

Global Impact:

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

Key Responsibilities:

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

• Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products) recent advances and challenges in the field. Expertise in independently conducting and directing the planning execution analysis and documentation of all stages of cell culture process commercialization. Risk assessment control strategies process comparability reports Process performance qualification and/or regulatory submissions.

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

• Leadership:Establish and manage Cell Banking working groups support CMC teams and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization serving as the scientific/technical mentor for junior staff. Action-oriented mindset for creativity; ability to take initiative innovate iterate and problem-solve.

• Cross-Functional Collaboration:Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity inclusion and equity. Experience and aptitude to lead work and collaborate in internal and external cross-functional 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:Drive project schedules set clear priorities and monitor performance metrics. Adaptability and agility to prioritize and deliver complex objectives often 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.

Education & Experience:

• Bachelors degree in Chemical Engineering Bioengineering Biological Engineering or a related field with sixteen (16) years of relevant industry experience. OR

• Masters degree in Chemical Engineering Bioengineering Biological Engineering or a related field with twelve (12) years of relevant industry experience. OR

• Ph.D. in Chemical Engineering Bioengineering Biological Engineering or a related field with minimum eight (8) years or relevant industry experience.

What You Bring:

• Proven leadership of cross-functional teams in biologics development & commercialization

• Deep expertise in cell culture and cell bank (master cell bank and working cell bank) 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

Be a Catalyst for Innovation!

If youre passionate about biologics and ready to lead a high-impact team apply now and be part of a transformative journey in the world of cell banking and biomanufacturing!

Current Employees apply HERE

Current Contingent Workers apply HERE

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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