Scientific Director of Development and Validation
NewLink Genetics - Ames, IA

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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