Who we are:
A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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 Sr. Scientist/Scientist for the Carlsbad Viral Vector Manufacturing Facility to serve as 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, prepare reports, streamline processes, interact with clients, train manufacturing operators, and execute upstream and downstream unit operations under cGMP.
- Work with the process development team throughout development (early development, consistency runs, and scale-up) to define production process.
- Compile/generate data to provide documentation for the technology transfer package.
- Provide process development oversight and upstream and downstream technical support/troubleshooting for Engineering and cGMP runs.
- Generate SOPs, item specifications, batch records, and reports governing applicable production processes.
- Manage the Tech Transfer process: planning, bill of materials, scale-up on upstream and downstream process parameters, testing methods, specifications, method and equipment validations, etc.
- Provide the Engineering run technical evaluation and approve parameter changes and support the documentation required to justify the changes in cGMP.
- Collaborate in cross-functional work and training on the Tech Transfer team.
- Serve as point of contact with clients during production campaigns.
- Execute 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.
- Provide technical support during client and regulatory agencies site audits.
- 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:
- BS or MS in Chemical Engineering, Chemistry or Life Science related
- Experience with large molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (attached and suspension), and single use systems.
- 6+ years pharmaceutical process development, engineering and/or manufacturing experience required.
- Innovative approach to problem-solving and integrated view of business/scientific issues.
- 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 a FDA regulated manufacturing environment.
- Professional interaction with other teams and clients.
- Excellent computer, verbal, and written communication skills.
What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfill 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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.