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 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 Manufacturing Senior Specialist position is responsible for leading the preparation and the execution of the manufacture of a cGMP pharmaceutical product for client projects. This position may/may not have direct supervisory responsibility of employees, but does have overall responsibility for the Projects they are assigned to. The Senior Specialist will be responsible for developing custom Master Batch Records, communicating with internal and external clients, and leading cGMP manufacturing operations. Senior Specialists are expected to uphold strict compliance to cGMP manufacturing and quality policies, ensure their team is properly prepared and trained, and to demonstrate good documentation practices in accordance with cGMP standards. Senior Specialists are expected to operate in a manner that promotes the safety and well-being for both the employees performing the work, as well as the Product being manufactured.
Who You Are:
- Bachelor of Science degree and 4+ years of experience OR HS Diploma or GED and 8+ years’ work experience in a cGMP clean room environment performing aseptic manufacturing operations.
- 4+ years’ experience understanding of cGMP/GDP concepts
- 4+ years’ experience with sterile cell culture and aseptic operations in a BSC/LFH (bio safety cabinet, laminar flow hood)
- 4+ years knowledge of biology and chemistry
- 4+ years’ experience troubleshooting equipment and process failures
- 4+ years’ experience working knowledge of desktop computers and technical equipment (MS Office)
- 2+ years’ leadership experience while executing cGMP documentation and providing technical training to junior employees
- 2+ years’ experience working with multi-department functional teams
- 2+ years’ experience drafting and revising cGMP procedures and Master Batch Records
- 2+ years’ experience communicating with internal and external customers
- Experience with Project Planning and Scheduling
- Experience with filtration, TFF (UF/DF), column chromatography, sterile final filtration, media and buffer preparation operations highly preferred
- Disposable bioreactors (25 to 100L, Wave, SUB), viral vector manufacturing experience preferred
- Experience with Bulk Drug Formulation and Dilution preferred
- Experience Tangential flow filtration (UF/DF) with hollow fiber membranes preferred
- Experience with sterile fill filtration of media, buffers, and drug products preferred
- Experience with GE AKTA Purification Skid operation / column chromatography / column packing preferred
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.