AddressDescription
Johnson & Johnson Innovative Medicine Research & Development is recruiting for a Scientist, Analytical Development- Separation Sciences, in the Therapeutics Development and Supply, Biologics Development (TDS Biologics - AD) group, located in Malvern, PA.
At Johnson & Johnson Innovative Medicine, 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.
Johnson & Johnson Innovative Medicine R&D discovers and develops innovative medical solutions to address important unmet medical needs in the areas of Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.
We are Johnson and Johnson Innovative Medicine. 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 Discovery, Product Development, and Supply (DPDS), Analytical Development (AD) group is seeking a Scientist to support our dynamic Analytical DevelopmentSeparation Sciences team. The experienced and motivated Scientist will be responsible for development, validation, and transfer of separation assays for protein biotherapeutics including but not limited to monoclonal antibodies, bi- and tri-specific antibodies and antibody drug conjugates to be used in support of clinical and commercial development. Are you interested in joining a diverse and dynamic team that is helping improve patient care and drive innovation? You will work and grow in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.
Key Responsibilities:
- Develop, validate, and transfer biochemical methods such as capillary electrophoresis (CE) and HPLC methods for characterization and quality control of biopharmaceutical products
- Serve as the analytical technical expert during method development, investigations, and regulatory inspections
- The scientist will seek and implement innovative separation technology to meet increasing analytical challenges for new modalities.
- Lead one or more analytical projects and partner with process development scientists, analytical integrator, QC scientists to support programs ranging from early phase through late phase clinical development and commercial manufacturing.
- Write, review, and approve methods, validation/transfer protocols, technical reports, SOPs and present data to peers and functional management.
- Author/review relevant sections of regulatory filings including but not limited to INDs, IMPDs and BLAs and answer questions from the health authorities.
- Contribute to improvement in laboratory operations to increase efficiency and GMP compliance
Qualifications
Education:
- Ph. D. with a minimum 0-4 years of Pharma/biotech industry /post-doctoral experience, a Master's degree with a minimum 5 years of Pharma/biotech industry experience, OR a Bachelor's degree with a minimum 12 years of Pharma/biotech industry industry experience.
- Degree in Biochemistry or related scientific field preferred.
Required:
- Strong Biochemistry background
- Strong analytical problem-solving skills for developing creative, innovative solutions, and meeting project objectives
- Excellent organization, communication, presentation skills and scientific/technical writing skills
- Excellent leadership, interpersonal, and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams
- This position is to be based in Malvern, PA and may require up to 10% travel.
Preferred:
- Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters
- In-depth large molecule Analytical Development experience with focus on Separation methods such as HPLC and capillary electrophoresis techniques.
- Experience with commercialization of therapeutic proteins, antibodies and antibody drug conjugates
- Must be meticulous, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality data.
- Ability to make timely decisions and operate efficiently in times of ambiguity
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
