Job Seekers, Please send resumes to resumes@hireitpeople.com
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
