Sr. Specialist Manufacturing

Company: Millipore Corporation
Location: Carlsbad
Posted on: January 15, 2021

Job Description:

Your Role: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 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.Basic Qualifications:* 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' 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 customersPreferred Qualifications:* Experience with Project Planning and Scheduling* Experience with filtration, TFF (UF/DF), column chromatography, sterile final filtration, media and buffer preparation operations* Disposable bioreactors (25 to 100L, Wave, SUB), viral vector manufacturing * Experience with Bulk Drug Formulation and Dilution* Experience Tangential flow filtration (UF/DF) with hollow fiber membranes* Experience with sterile fill filtration of media, buffers, and drug products * Experience with GE AKTA Purification Skid operation / column chromatography / column packing RSRMSSDL2017

Keywords: Millipore Corporation, San Diego , Sr. Specialist Manufacturing, Other , Carlsbad, California