This individual will lead the development of manufacturing processes for new products from benchtop scale to commercial scale using Quality by Design approach (ICH Q8). They will lead the manufacturing of development batches, facilitate project communication and issue resolution with internal and external customers, and provide technical manufacturing process expertise as required. They will transfer benchtop scale manufacturing processes from customer site to Lifecore;serve as a technical resource for process development, evaluation, and validation projects related to fermentation, downstream processing, and/or aseptic manufacturing; lead manufacture of pre-GMP and GMP development batches; perform critical analysis of data, interpret results, and draw scientific conclusions; present data at group meetings; write development reports as required.
Requirements: BS/BA in chemistry, biochemistry, chemical engineering, or related science with5-8 years of biotechnology or pharmaceutical related process development experience. Experience with processes or methods used in the pharmaceutical or biotechnology industry;FDA regulated industry experience. Experience with biopolymers preferred.
Job Posted by ApplicantPro
Lifecore Biomedical, Inc. is a wholly owned subsidiary of Landec Corporation (Nasdaq: LNDC). We remain fully committed to the quality and service that ensures our products meet the highest standards set by the United States Food and Drug Administration, the European Community and other international agencies.
We operate two facilities that are ISO 13485 and GMP certified, international symbols of quality system assurance and compliance.
Lifecore Biomedical LLC