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 Director will be responsible to provide expedited method validation and process validation support during the preparation of Biologics License Applications for a family of oncology therapies with products now in late Phase clinical testing. The Director will report directly to the Clinical and Regulatory Compliance Officerand directly communicate with executive management.
Supervise and allocate staff as needed to address projects in method development and qualification/validation and process development/validation
Designs method development, qualification, and validation protocols for characterization of mammalian cells including viability, growth kinetics, FACS, and ELISA assays.
Provides scientific, technical, and cGMP oversight of biologic processes and methods
Writes and reviews documents for regulatory submissions
Drafts, edits, reviews and approves applicable SOPs and protocols.
Must have scientific and technical expertise in characterization of mammalian cells
Must have pharmaceutical or biotech industry experience in method development, qualification and validation
Excellent communication and organizational skills
Highly self motivated
Education and Experience:
PhD in cell biology or other related science field
At least 5 years of experience within regulated industry
Prior experience in supporting successful BLA submissions is a major advantage