Janssen Research & Development, LLC ., a division of Johnson & Johnson’s Family of Companies is recruiting for anSenior Scientist, located inMalvern, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visithttp://www.janssenrnd.com/for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. The successful candidate will work in the large molecule/biologics Drug Product Development (DPD) department. The incumbent will independently develop, design and perform material evaluation and characterization in support of formulation, process and fill-finish activities. Additional duties and responsibilities to include:
- Design and execute experiments in support of formulation development of biologic drug candidates and study the molecular interactions of the drug product to materials (ancillaries) associated with dosage preparation and delivery to the patient. Added scope will include freeze-thaw and heat transfer, mixing, filtration, pumping, filling and lyophilization; and how the drug product interacts with the product contact material surfaces during fill/finish manufacturing.
- Perform physical and chemical testing on raw materials, in-process and finished product samples. This includes research, preparation, and review of technical documents, including but not limited to SOP’s, drug master files, vendor qualification, technical packages, compendia, protocols, raw material and intermediate specifications, test methods, certificates of analysis, method validation reports which conform to company and regulatory standards.
- Prepare documents for regulatory filings (ANDA, NDA, ANDS) and internal company use. Design experiments and provide relevant data to support responses for FDA minor deficiency letters.
- Participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations.
- MS with at least 10 years industry experiencein Material Sciences, Chemical Engineering orPharmaceutical Sciences or related Scientific disciplineOR a PhD with at least 3 years industry experience in Material Sciences, Chemical Engineering orPharmaceutical Sciences or related Scientific discipline is required
- Demonstrated proficiency in a variety of analytical instruments and software utilized for physical and chemical analysis is required
- Knowledgeable in evaluation of product contact material extractable and leachable compounds, including analytical characterization and toxicology assessments (such as ICP-MS, etc.) is required
- Familiarity with a variety of compendial references including United States Pharmacopeia is required
- Experience maintaining high quality documentation, analyze and properly interpret data, and prepare reports, SOPs or other technical reports is required
- Technical writing and data analysis skills is preferred
- Knowledge and experience of biopharmaceutical formulation and process designand fill/finish operations is preferred
- Competency at trouble-shooting process issues based on scale-down/scale-up experience is preferred
- A strong understanding and experience in the application of various GXP and QbD concepts is preferred
- Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, and particle methods) is preferred
- Familiarity with biophysical techniques such as DSC, rheometry (including viscometry), light scattering (SLS and DLS), and interfacial tension is preferred
- Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices and how proteins/biologically derived substances interact with the closure surface is preferred
- Knowledge of surface analysis (chemical and physical) is preferred
Primary LocationNorth America-United States-Pennsylvania-MalvernOrganizationJanssen Research & Development, LLC. (6084)Job FunctionR&D
Internal ID: 0401170915
Location/Region: Malvern, PA (US)