Sr. Specialist Manufacturing
Company: Millipore Corporation
Location: Carlsbad
Posted on: January 15, 2021
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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
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