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 Biopharmaceutical Microbiologist will be working in a cGMP environment and will work under the direction and will support the Director of Quality in the implementation of a microbiology program. The individual will also be supporting other departments who may require microbiology test support or microbiological advice.
Knowledge in microbiology science must be complemented by understanding of microbiology applied to the pharmaceutical manufacturing environment and knowledge of FDA regulatory requirements for sterile manufacturing.
The individual will be responsible for coordinating microbiology related activities, including the implementation and maintenance of an environmental monitoring program, as well as a microbial control in-process and raw material testing program.

Responsibilities:

• Works under the direction and supervision of the Director of Quality

Supports the Director of Quality in the implementation of microbiology related activities including, but not limited to:

• Implementation and maintenance an environmental monitoring program
• Implementation and maintenance a microbial in-process and raw material testing program
• Draft and revision of applicable SOPs
• Participation in the generation and approvals of investigations, CAPAs, and change controls related to microbial issues
• Participation in training of other employees on microbiology related topics
• Performs other duties, as required

Qualifications:

• Must have a microbiology degree
• Must have experience/exposure within FDA regulated industry, preferably in parenteral drugs or biologics
• Strong computer user skills required especially with Microsoft Office
• Strong attention to details
• Highly self-motivated

Education and Experience:

• B.S in Microbiology with extensive experience in an FDA regulated environment, or a Master or PhD degree in Microbiology with experience in an FDA regulated industry

We offer a diverse workforce with a competitive salary and benefit package.
Please apply using the linked Application Form