Staff Scientist, Tech Transfer
MilliporeSigma

Job Info

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A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

The Carlsbad Gene Therapy Viral Vector Manufacturing facility is a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a Staff Scientist, Technology 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 of major scope, to transfer internal and client-facing processes from development to manufacturing by collaborating cross-functionally with both internal and external stakeholders, providing guidance to meet timelines and resolve complex technical/operational issues
• Supervise Tech Transfer team members and actively manage performance and development
• Generate 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 and purification processes and train manufacturing staff as needed
• Source materials internally/externally for the completion of full-scale pilot runs and define final material and labor requirements for manufacturing
• Develop solutions and execution strategies in scientifically complex and novel situations; identify, evaluate, and implement new methodologies
• Apply expert knowledge of FDA and EMA guidance to procedures and processes, and provide technical support during client and regulatory site audits as needed
• Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose solutions

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field with 20+ years experience in process development, engineering and/or manufacturing experience
• 8+ years direct experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), or single-use systems
• 3+ years supervisory experience in leading technical/operations or development teams, providing mentorship and coaching to junior staff

OR

• Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field with 15+ years experience in process development, engineering, and/or manufacturing experience
• 8+ years direct experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), or single-use systems
• 3+ years supervisory experience in leading technical/operations or development teams, providing mentorship and coaching to junior staff

OR

• PhD in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or other Life Science related field with 8+ years' experience in process development, engineering and/or manufacturing
• 8+ years direct experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), or single-use systems
• 3+ years supervisory experience in leading technical/operations or development teams, providing mentorship and coaching to junior staff

Preferred Qualifications:

• Experience with cGMP manufacturing and Quality Systems within a regulated environment
• CMO experience
• Subject matter expertise in large scale suspension (≥200 L) viral vector process development (e.g., lentivirus, adeno-associated virus) and mammalian cell culture process optimization
• Strong statistical analysis (JMP) skillset and familiarity with design of experiments (DOE) studies
• 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
• Excellent attention to detail, with superior documentation and organization skills
• Excellent computer, verbal, and written communication skills, including strong technical writing ability and a demonstrated ability to communicate scientific ideas to a broader cross-functional (technical/non-technical) audience

RSRMS

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 229498

Location: Carlsbad

Career Level: E - Professional (10+ years)

Working time model: full-time

This job has expired.