Senior Scientist, Analytical Testing

About the role

This position is part of the Analytical Regulated Testing GMP team at BMS New Jersey within Analytical Strategy & Operations. The scientist performs analytical method validation and cGMP activities and provides oversight and strategy to support clinical and commercial development for small molecule New Chemical entities and Investigational Medicinal Products.

Responsibilities

• Follow GMP/GLP guidelines in the acquisition and/or review of data related to method validation and/or testing of release, stability and development materials; may guide others in these activities.
• Apply a phase-appropriate approach to GMP in laboratory work and documentation.
• Coordinate method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
• Maintain the laboratory in an ‘audit ready’ status and participate in audits and inspections.
• Contribute to the establishment and implementation of corrective actions for findings.
• Prepare, and may approve, reports for methods, validation, and technology transfer.
• Prepare and/or review operational procedures, testing protocols/reports and training materials.
• Practice and assist in implementation of best practices associated with laboratory Quality Systems including training, procedures, instrumentation management, and data and records management.
• Prepare and/or approve plans and tools for continuous improvement of quality and compliance.
• Identify deviations to quality systems or limits/specifications and ensure timely resolution.
• Lead and participate in investigations, including preparation and implementation of corrective actions (CAPAs).
• Prepare responses to questions from regulatory agencies related to analytical data and procedures.
• Collaborate and communicate effectively with CMC sub teams to ensure API and drug product release testing, stability testing and filing requirements meet clinical timelines.

Qualifications & Experience

• Bachelor’s degree in analytical chemistry, organic chemistry, biochemistry, pharmacy or related field with 7+ years relevant industrial experience or equivalent, or
• Master’s degree and 4–6 years of experience, or
• PhD and 2–4 years of experience
• Demonstrated knowledge of IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
• Excellent interpersonal communication skills with capability of interfacing with and influencing multi-disciplinary teams.
• Experience with regulatory submissions and interaction with regulatory agency inspectors.
• Strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

Competencies

• Ability to prioritize project responsibilities to meet competing requirements.
• Adaptability to change and capacity to manage multiple projects effectively while meeting timelines.
• Skill in influencing teams and seeking opportunities to develop new and different ways to resolve project challenges.
• Proactive identification of opportunities and implementation of solutions to improve efficiency, productivity and quality/compliance.
• Strong verbal and written communication skills to effectively communicate with key partners both internally and externally.

Pay

New Brunswick, NJ, US: $109,270 – $132,407 (full-time). Additional discretionary incentive cash and stock opportunities may apply. Final compensation is guided by pay equity principles and applicable employment laws and may be adjusted over time.

Benefits

Subject to applicable plan terms, eligible employees may participate in comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO) with 11 paid company holidays; non-exempt employees, RayzeBio employees, and employees in Puerto Rico receive 160 hours of paid vacation annually plus 11 paid company holidays and 3 optional holidays. Additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement or military needs. Eligible employees also receive an annual Global Shutdown between Christmas Day and New Year’s Day.