Executive / senior industry position
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.
- 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 of SOPs, Item Specification, Batch Records and reports governing applicable production process.
- 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 Degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field, with 7+ years of experience in pharmaceutical process development, engineering and/or manufacturing.
- Master’s Degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field, with 5+ years of experience in pharmaceutical process development, engineering and/or manufacturing.
- 3+ years of experience with cGMP manufacturing and Quality Systems within a FDA regulated manufacturing environment.
- 3+ years of Experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems is required.
- PhD in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field.
- 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 experience under cGMP.
- Innovative approach to problem-solving and integrated view of business/scientific issues.
- Work independently or as part of a team and manage multiple projects simultaneously.
- Detail oriented and organized.
- Possess a positive, friendly and professional demeanor.
- Excellent computer, verbal, and written communication skills.