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Job Responsibilities:

Participate CMC related projects such as APS, batch record finalization, process performance qualification, stability studies  Review batch records with internal process engineers and finalize them for commercialization  Write APS related documents (SOPs, FRMs)  Write stability studies documents (SOP, BOP, FRM and protocols) for materials and final product  Lead material stability execution and coordinate internal and external testing  Write summary reports for stability studies  Provide in process sub-teams related to CMC work and provide input  Finalize process flows for manufacturing process and develop controls through procedural controls where required  Assist in other tasks on process sub team as process engineering resource 

Detailed Job Description: 

Undergraduate degree in Life Sciences or 8 years direct, relevant experience in Bio/Pharmaceutical product manufacturing to provide a comparable background  Minimum of 8 years' experience within the biopharmaceutical or healthcare industry  Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing  Proficient knowledge of Microsoft Office software, and other general office equipment.  Project management experience or experience as part of a project team or project team leader.  Understanding of risk management principles  Process validation and continuous process monitoring experience preferred  Control strategy, SOP and batch record documentation experience and skills  Must be familiar with biologics products

Experience required: 8 Years