Director, Drug Substance Working Group Leader

Job Description

Lead the Future of Biologics Drug Substance Commercialization!

Are you a bold strategic thinker with a passion for biologics Were looking for a dynamic and visionaryDirector Drug Substance Leaderto drive innovation and excellence across our Biologics Science & Technology (S&T) portfolio. In this high-impact role youll lead the Drug Substance Working Group (DSWG) mentor scientific talent and partner cross-functionally to bring transformative therapies to patients worldwide.

What Youll Do:

• Establish and lead Drug Substance working groups (DSWG) across the Biologics Commercialization portfolio
• Support CMC teams and align resources to deliver on program priorities
• Mentor and develop a team of scientists focused on biologics commercialization
• Foster a culture of initiative creativity and problem-solving
• Deliver robust DS process and analytical strategies to enable successful commercialization
• Provide technical oversight for DS process development characterization and regulatory filings
• Ensure smooth execution of PPQs and BLAs for pipeline assets
• Bring deep expertise in biologics DS processing (large molecule products)
• Lead planning execution analysis and documentation of cell culture process commercialization
• Drive risk assessments control strategies comparability reports PPQ and regulatory submissions
• Support and contribute to regulatory filings (IND MAA BLA)
• Prepare for and support inspections with global health authorities (FDA EMA JNDA TGA)
• Unite diverse internal and external teams to deliver as One Team
• Champion compliance safety and a culture of diversity equity and inclusion
• Foster transparency and collaboration across stakeholders and governance bodies
• Communicate effectively across all levels of the organization
• Drive project schedules set clear priorities and monitor performance metrics
• Recognize team achievements and promote a culture of appreciation
• Lead business improvement initiatives and leverage networks to drive change
• Enhance data monitoring capabilities and manufacturing robustness
• Collaborate with colleagues across the U.S. and internationally to elevate standards in cell banking manufacturing testing and storage. Your leadership will shape the future of biologics on a global scale.

Minimum Education Required & Experience:

• Bachelors Degree in Chemical Engineering Bioengineering Biological Engineering or related field with sixteen (16) years of relevant experience. OR
• Masters Degree in Chemical Engineering Bioengineering Biological Engineering or related field with twelve (12) years of relevant experience. OR
• Ph.D. in Chemical Engineering Bioengineering Biological Engineering or related field witheight (8) yearsof relevant industry experience

What You Bring:

• Proven leadership of cross-functional teams in biologics development & commercialization
• Deep expertise in DS manufacturing operations (cell culture and purification)
• Strong understanding of regulatory requirements and inspection readiness
• Ability to lead without authority build trust and inspire accountability
• Ethical resilient and committed to scientific and operational 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 this is your moment. Join us and be part of a transformative journey in DS commercialization and biomanufacturing.

Current Employees apply HERE

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U.S. Hybrid Work Model

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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Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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