Sr. Scientist, Tech Transfer
Millipore Corporation

Job Info

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Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

This position is eligible for a $7,500 sign-on bonus for those that qualify!

Your Role:

The Carlsbad Gene Therapy Viral Vector Manufacturing facility in Carlsbad, CA is a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a Sr. Scientist, Tech Transfer who will be responsible for supporting process transfer from Development to cGMP Manufacturing as a member of the Tech Transfer team within Technical Operations. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work cross-functionally with the Manufacturing, Process Development, and Project Management teams to ensure successful and timely process transfer and scale-up for critical client-facing projects.

• Lead projects to transfer internal and client-facing processes from development into manufacturing, conduct operational readiness reviews with site management team, and provide manufacturing science and technology (MSAT) support to early-stage production campaigns
• Generate and update cGMP documentation (item specifications, batch records, SOPs, bills of material, production summaries, etc.) based on inputs from the development team and requirements/constraints provided by the manufacturing, quality, and operations teams
• Support the execution of engineering/pilot runs for viral production, purification, formulation and filling processes and train manufacturing staff as needed
• Collaborate with Supply Chain to identify, select, and source the materials required for completion of full-scale pilot runs, and define material, planning, and labor requirements for transferred manufacturing processes with a continuous focus on cost reduction opportunities
• Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose corrective actions and continuous improvement plans
• Perform other duties as indicated by business needs

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science discipline
• 15+ years of experience in process development, engineering, and/or manufacturing science and technology (MSAT)
• 5+ years of experience with upstream, downstream, and/or formulation and fill processes for large molecule biopharmaceutical production, with emphasis on large-scale single-use systems and aseptic processing
• 2+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment

OR

• Master's Degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science discipline
• 10+ years of experience in process development, engineering, and/or manufacturing science and technology (MSAT)
• 5+ years of experience with upstream, downstream, and/or formulation and fill processes for large molecule biopharmaceutical production, with emphasis on large-scale single-use systems and aseptic processing
• 2+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment

OR

• PhD in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related discipline

• 5+ years of experience in process development, engineering, and/or manufacturing science and technology (MSAT)
• 5+ years of experience with upstream, downstream, and/or formulation and fill processes for large molecule biopharmaceutical production, with emphasis on large-scale single-use systems and aseptic processing
• 2+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment

Preferred Qualifications

• CMO experience
• Subject matter expertise in large-scale upstream or downstream bioprocessing
• Solid track record of identifying and proposing solutions to improve the scalability and efficiency of both manufacturing and documentation processes
• Familiarity with cGMP document control systems and general procedures and a working knowledge of FDA and EMA regulatory requirements
• Excellent attention to detail, with superior documentation and organization skills
• Excellent technical writing skills and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience

Pay Range for this position - $49,500 - $148,900

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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