SENIOR ASSOCIATE SCIENTIST, ANALYTICAL DEVELOPMENT – SEPARATION SCIENCES

Johnson & Johnson Innovative Medicine Research & Development is recruiting for a Senior Associate Scientist, Analytical Development – Separation Sciences, supporting Therapeutics Development and Supply, Biologics Development (TDS Biologics - AD) group 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.
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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 Therapeutics Development and Supply, Biologics - Analytical Development (AD) group is seeking a Senior Associate Scientist to support our dynamic Analytical Development Separation Sciences team.
The experienced and motivated Senior Associate Scientist will be responsible for providing leadership and support for analytical laboratory instrumentation and support the development, validation, and transfer of separation assays for gene therapy products and other protein biotherapeutics 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.
Supports TDS-Biologics AD Separation Sciences organization with Functional Support for Analytical Laboratory Instrumentation.
Work in a team environment as well as contributing individually to meet project timeline and objectives.
Manage laboratory instruments to assure preventive maintenance, calibration, qualification, and repairs are documented and completed in a timely manner.
Collaborate with multiple vendors who provide instrumentation support activities.
Audit vendor instrumentation documentation to ensure in time and accuracy of documentation.
Provide documentation support including data entry, verification and documentation process follow up.
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 Seek and implement innovative separation technology to meet increasing analytical challenges for new modalities.
Contribute to improvement in laboratory operations to increase efficiency and GMP compliance.
Qualifications Bachelor’s degree in Biology, Chemistry, Pharmacology or related subject area with at least 5 years of relevant industry experience or Master’s degree with at least 4 years of relevant work experience is required.
Degree in Biochemistry or related scientific field preferred.
Experience and Skills.
Required.
Experience in analytical or relevant industry laboratories with a solid understanding of GMP regulations is required.
Knowledge of a wide variety of laboratory instrumentation required Must possess understanding of change control process and experience in handling change controls.
Excellent leadership, communication, interpersonal, and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams Must be meticulous, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality results.
Ability to work with limited guidance to plan, execute, and follow through with work assignments and drive completion of activities in a timely manner is expected.
This position is to be based in Malvern, PA and may require up to 10% travel.
Preferred.
Large molecule Analytical Development experience with focus on Separation methods such as HPLC and capillary electrophoresis techniques.
Strong analytical problem-solving skills for developing creative, innovative solutions, and meeting project objectives Experience in supporting information systems like SAP, Maximo, and Document Management Systems Excellent presentation skills and scientific/technical writing skills 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.