Senior Associate Scientist-Downstream API

Johnson & Johnson Innovative Medicine, a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Associate Scientist, Downstream Process Development, to be located in Malvern, PA.

At J&J Innovative Medicine, we never stop working toward a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com.

The Senior Associate Scientist will support early and late phase downstream process development, including chromatography, harvest clarification, virus removal and inactivation, ultrafiltration/diafiltration and any other required downstream process steps developed at the Malvern, PA site. The Senior Associate Scientist may also be responsible for supporting Technical Transfer, Manufacturing investigations, and Regulatory filings related to downstream process stages.

Key Responsibilities:

• Participate in design of experiments for chromatography, harvest clarification, virus removal filtration, UF/DF, and any other required downstream process steps.

• Perform study execution.

• Document experimental execution.

• Record and analyze data.

• Maintain accurate laboratory documentation and author technical reports.

• Participate in tech transfer, facility fit, and process scale up/ scale down.

• Support/Lead early Technical Transfer activities through generation of protocols/reports, technical writing, and execution of laboratory scale studies.

• Support/Lead "process fit to plant" during early stages of development to provide guidance to both development and manufacturing teams.

• Support/Lead "person in plant" by providing support during manufacturing campaigns for new product introduction (NPI) campaigns.

• Provide expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.

• Participate in scientific investigations and trouble-shoot process issues that arise during development, technology transfer, or scale-up.

• Contribute to regulatory filings.

• Effectively work in a team environment as well as contributing individually to meet project objectives and timelines.

• Other duties will be assigned, as necessary.