Job Description

Sr Manager, Quality Control

The Opportunity:

Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP). The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

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  Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to method validation and method transfer
  
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  Author and/or review QC related documents, including methods, protocols, reports and memos
  
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  Perform data review in support of GMP activities for release, in-process, and stability testing as well as method validation and transfer
  

Required Skills, Experience and Education:

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  BS or MS in Chemistry, Pharmaceutical Science or related discipline
  
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  6+ years of relevant industrial experience in analytical development/QC with Commercial QC experience is preferred
  
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  Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, sampling and testing, stability study, method validation and transfer, etc.
  
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  Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills
  
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  Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
  
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  Ability to multi-task and thrive in a fast-paced innovative environment
  

Preferred Skills:

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  Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills
  
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  Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
  
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  Ability to multi-task and thrive in a fast-paced innovative environment
  

Job Tags

Contract work,

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