Job Information
Janssen Research & Development, LLC Scientist Large Molecule Drug Product Development in Malvern, Pennsylvania
Employer: Janssen Research & Development, LLC Job Title: Scientist Large Molecule Drug Product Development Job Code : A011.4183 Job Location: Malvern, PA Job Type: Full-Time
Job Duties: Develop and optimize manufacturing processes for protein-based pharmaceutical products including novel drug delivery technology such as long-acting injectable and lipid nanoparticle. Design, execute, and lead formulation and process development experiments for monoclonal antibodies and other protein candidates. Studies include, but not limited to, formulation development, process development, stability, robustness, and the development of fill/finish processes. Lead, facilitate, and participate in technical discussions to successfully resolve problems with suppliers, methods, pipeline program issues, and deviations. Work independently and in conjunction with appropriate teams to define scientific strategy and to support program/project needs. Independently lead, design, and perform development and characterization in support of formulation, process, and fill-finish activities for large molecules including mAbs, fusion proteins, bi-specifics, etc. Author and review documents for regulatory filings (IND, IMPD, BLA, MAA) and internal company use. Design experiments and provide relevant data to support responses for regulatory agencies minor deficiency letters. Provide matrix leadership and support people development. Promote scientific advancement through knowledge of current landscape, external engagement, and industry direction.
Requirements: Employer will accept a Ph.D. degree in Chemical, Biomedical, Mechanical, Bioengineering, or related engineering field and 3 months of experience in the job offered or in a Scientist Large Molecule Drug Product Development-related occupation.
CONTACT: To apply, please send resume to jkim6240@its.jnj.com. Please refer to Job #A011.4183.