AddressDescription
Employer: Janssen Research & Development, LLC
Job Title: Scientist, Large Molecule Drug Product Development
Job Code : A011.3786
Job Location : Malvern, PA
Job Type: Full-Time
Job Duties: Lead process development studies to determine and characterize process parameters associated with preparation of biologic Drug Products. Lead, design, and perform formulation and process development in support of development activities related to Large Molecules (e.g. monoclonal antibodies, fusion proteins, bi-specifics, gene therapies, cell therapies, RNA/lipid nanoparticles etc.). Studies include, but are not limited to: Process development, freeze-thaw, mixing, filtration, pumping, filling, biophysical characterization, stability, composition robustness, lyophilization, spray drying, spray-freeze drying and other high concentration technologies. Formulation development including accelerate and real-time stability, excipient screening and selection, and freeze/thaw stability. Lead, facilitate, and participate in technical discussions to successfully resolve problems with suppliers, methods, project issues and deviations. Supervise, guide, and mentor junior scientists within Drug Product Development and Device. Participate in the overall strategic design, development and deployment of Large Molecule therapeutics to ensure competitiveness and organizational excellence. Deliver an improved focus on the engineering concepts, ensuring consistent scientific excellence and scientific quality standards are met.
Qualifications
Requirements: Master's degree in Pharmaceutical Engineering, Biomedical Engineering, Chemical Engineering or related field and 5 years of experience in the job offered or in a Scientist, Large Molecule Drug Product Development-related occupation. Position requires experience with:
1. Biologics Drug Product and device development (mAbs, RNA/LNP, gene therapies, and/or cell therapies) within the pharmaceutical industry;
2. Large and small molecule parenteral suspensions including process and formulation development and characterization of said suspensions;
3. Development and implementation of novel pharmaceutical methodologies;
4. Multiple aspects of drug development including technical, regulatory, and project management;
5. Design controls for drug development, engineering and process controls equipment installation;
6. Conducting experiments to characterize drug substance, product, and related materials;
7. Evaluations of new drug delivery technologies; and
8. Performing technical due diligence and vendor selection.
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 .]
