Associate Scientist, Downstream Process Development - 2306145743W

　　Description

　　Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for an Associate Scientist, Downstream Process Development, to be located in Malvern, PA.

　　At Janssen, 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 Associate Scientist will support downstream process development projects and clinical manufacturing operations at the Malvern, PA site and may be responsible for leading Process Development, Technical Transfer, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.

　　Key Responsibilities:

　　Participate in design of experiments.

　　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, execution of laboratory scale studies and participation in manufacturing operations and NPI initiatives.

　　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 4 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 and 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 .

　　Primary Location NA-US-Pennsylvania-Malvern

　　Organization Janssen Research & Development, LLC (6084)

　　Job Function Biotherapeutics R&D

　　Req ID: 2306145743W