A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a Life Cycle Specialist II who will be responsible for supporting client-facing projects as a member of the Life Cycle Management 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 Quality teams to implement changes to bioprocesses in cGMP production.
- Collaborate cross-functionally with both internal and external stakeholders to implement changes which enable continuous improvement, scale-up, and sustaining of existing cGMP manufacturing processes.
- Support the execution of process risk assessments, qualification protocols and reports, and other operational activities that increase safety, reduce operation costs, and maintain cGMP compliance.
- Coordinate and drive change orders and related efforts to update manufacturing documentation including batch records, item specifications, forms, SOPs, and bills of material for existing processes.
- Assist with internal projects to develop and optimize process and product Life Cycle Management and ensure robustness, repeatability, and scalability of cGMP operations.
- Engage internal teams to resolve Corrective Action/Preventive Action (CAPA) relating to existing cGMP manufacturing and documentation in a timely manner.
- Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose solutions.
- Provide technical support during client and regulatory site audits as needed.
Who You Are:
- Bachelor Degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field and 3+ years of experience process development, engineering and/or manufacturing OR Master Degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field and 1+ years of experience process development, engineering and/or manufacturing.
- 1+ years of experience with cGMP manufacturing and Quality Systems within a regulated environment.
- Experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems.
- CMO experience.
- Proficiency in reading, understanding, and improving manufacturing-facing and/or client-facing process documentation.
- Ability to identify and propose solutions to improve the scalability and efficiency of both manufacturing and documentation procedures.
- Familiarity with cGMP document control systems and general procedures.
- Ability to work independently and as part of a team on multiple projects simultaneously.
- Excellent attention to detail, with superior documentation and organization skills.
- Excellent computer, verbal, and written communication skills, including strong technical writing ability.
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
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