Sr. Scientist, Biologics Analytical Development Full-time

Sr. Scientist, Biologics Analytical Development

Therapeutics, Development, and Supply (TDS), Proteins Analytical Development (AD) group is seeking a Sr. Scientist to support our dynamic Analytical Development (AD) Separation Sciences team. The experienced and motivated Senior 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. You will work and grow in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.

You will be responsible for:

• Developing, validating, and transferring biochemical methods (e.g., capillary electrophoresis and HPLC) for the characterization and quality control of biopharmaceutical products
• Serving as the analytical subject matter expert during method development, investigations, and regulatory inspections
• Identifying, evaluating, and implementing innovative technologies and approaches to address emerging analytical challenges for new modalities
• Leading one or more analytical projects, collaborating with analytical integrator and cross-functional partners (e.g., process development scientists, QC scientists) to support programs from early clinical development through commercialization
• Providing analytical expertise to support programs across early- and late-stage clinical development and commercial manufacturing
• Leading continuous improvement initiatives to enhance analytical methods, processes, and laboratory practices
• Analyzing complex data sets and communicating findings clearly and concisely to technical and non-technical stakeholders
• Authoring, reviewing, and approving analytical methods, validation and transfer protocols, technical reports, and standard operating procedures, and presenting data to peers and functional leadership
• Authoring and reviewing sections of regulatory submissions (e.g., INDs, IMPDs, BLAs) and responding to health authority inquiries
• Contributing to laboratory operations improvements to enhance efficiency and ensure compliance with Good Manufacturing Practices (GMP)

Qualifications/Requirements:

Education:

• Ph. D. in Biochemistry or a related scientific field with 0-4 years of Pharma/biotech industry or post-doctoral experience OR a Master's degree with a minimum 5 years of Pharma/biotech industry experience OR Bachelor's degree with a minimum of 12 years of relevant work experience.

Experience and Skills:

Required:

• Strong foundation in biochemistry is required.
• Strong analytical problem-solving skills for developing creative, innovative solutions, and meeting project objectives is required.
• Proven scientific expertise with extensive hands-on experience in protein isolation and separation techniques, including electrophoresis and chromatography is required.
• Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters is required.
• Excellent organization, communication, presentation skills and scientific/technical writing skills is required.
• Excellent leadership, interpersonal, and negotiation skills with the ability to operate effectively in a dynamic work environment and collaborate with cross-functional teams is required.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.