NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutic products to improve cancer treatment options for patients and physicians. Our portfolio includes biologic and small-molecule product candidates intended to treat a wide range of oncology indications.
The Manager will be responsible for working with Quality Assurance to develop and maintain cGMP compliant procedures in support of Biologics License Application (BLA) for a cell based oncology immunotherapy currently in late phase clinical testing. Additionally the Manager will be responsible for working with Process Development, Manufacturing, and Quality Assurance to develop new product introduction protocols and requirements for products in early phase clinical testing.
- Hire and supervise staff as needed to address projects in process characterization/qualification, process development, and manufacturing scale-up
- Direct and motivate direct reports to achieve corporate objectives
- Work with QA to develop and maintain cGMP compliant processes to ensure manufacturing compliance in; deviation resolution, change control, corrective and preventative actions, and training.
- Work with MFG, QA, QC, and PD to ensure new product introduction requirements are met for new manufacturing products
- Write and review documents for regulatory submissions
- Draft, edit, review and approve applicable SOPs and protocols
Education and Experience:
- Must have scientific and technical expertise in culturing mammalian cells
- Must have pharmaceutical or biotech industry experience in cell culture manufacturing production
- cGMP experience in manufacturing clinical and/or commercial biologics
- Excellent communication and organizational skills
- Highly self motivated
We offer a diverse workforce with a competitive salary and benefit package.
- 5 years of cell culture process development experience strongly preferred
- At least 2 years of experience within regulated industry preferred
- At least 2 years of experience management experience very helpful
- Prior experience in supporting successful BLA submissions is a major advantage