Senior Associate Scientist-Downstream API

Description

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.

Qualifications

Education

A minimum of a Bachelor's degree in Chemical Engineering, Biological Sciences, or related scientific field with at least 6 years of proven experience is required.

Experience and Skills

Knowledge of and hands-on experience performing large molecule drug substance (API) downstream manufacturing process development is required. Highly organized and capable of managing/ pursuing multiple projects with some supervision is required. Good written and verbal communication skills are required. Excellent interpersonal skills with adaptability to rapid changes in project priorities and requirements is required. Acute attention to detail is required. Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required. Skills to report data, present findings to management is required. Occasional weekend work is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.