A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
MilliporeSigma is seeking a Technology Transfer Scientist for the Carlsbad Viral Vector Manufacturing Facility to serve as an SME for transferring bioprocesses to cGMP production. This individual will work within a team ensuring readiness for cGMP viral vector production. This includes but is not limited to scale-up unit operations, ordering materials, creating Batch Records, Item Specifications, and SOPs, preparing reports, streamlining processes, interacting with clients, train manufacturing operators on new processes, and support the execution of upstream and downstream unit operations under cGMP.
- Work with the process development team as required to define and scale-up production process unit operations that are robust, repeatable, and cGMP compliant.
- Provide process oversight and upstream and downstream technical support/troubleshooting for Engineering and cGMP runs.
- Compile/generate data and background information to provide documentation for the technology transfer package including the generation SOPs, Item Specifications, Batch Records, and reports governing applicable production processes.
- Support the Tech Transfer process including but not limited to planning, bill of materials, scale-up on upstream and downstream process parameters, testing methods, specifications, method and equipment validations, raw material sourcing support etc.
- Provide Engineering run technical evaluation and approve parameter changes and support the documentation required to justify changes for cGMP campaigns.
- Collaborate cross-functionally on various projects, including executing process risk assessments that support Process Development and Tech Transfer; develop, prioritize, and drive continuous improvements and other operational activities that increase safety, reduce operational costs, and accelerate timelines across all production aspects.
- Serve as the Tech Transfer point of contact with clients for various projects.
- Provide technical support during client and regulatory agencies site audits as needed.
- Proactively identify process gaps, perform root cause analysis, and propose solutions.
- Execute hands-on and train manufacturing staff in upstream and downstream unit operations in a cGMP environment.
Who You Are:
- Bachelor's in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field with 7+ years of pharmaceutical process development, engineering and/or manufacturing experience
- Master’s Degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field with 5+ years of pharmaceutical process development, engineering and/or manufacturing experience
- PhD in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field
- 2+ years of experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems.
- Innovative approach to problem-solving and integrated view of business/scientific issues.
- Strive to support and implement best-in-class systems and processes/procedures that comply with increasing regulatory standards.
- Work independently as part of a team and manage multiple projects simultaneously.
- Strategic planning/design, tracking, time and priorities management.
- Detail oriented and organized.
- Experience with cGMP manufacturing and Quality Systems within an FDA regulated manufacturing environment.
- Possess a positive, friendly and professional demeanor.
- Excellent computer, verbal, and written communication skills.
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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