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

• Follows GMP/GLP guidelines in the acquisition and/or review of data related to method validation and/or testing of release, stability and development materials.
• Applies a phase appropriate approach to GMP in laboratory work and documentation.
• May be responsible for coordination of method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
• Operates within and maintains the laboratory in an ‘audit ready’ status.
• Participates in audits and inspections.
• May contribute to the establishment and implementation of proper corrective actions for findings.
• Prepares, and may approve, reports for methods, validation, and technology transfer.
• Prepares and/or reviews 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.
• May prepare and/or approves plans and tools for continuous improvement of quality and compliance.
• Identify deviations to quality systems or limits/specifications, and ensures they are addressed in a timely manner.
• Lead and participates in investigations, including the preparation and implementation of corrective actions (CAPAs).
• May prepare responses to questions from regulatory agencies related to analytical data and procedures.
• Effective collaboration and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated 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 the 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.
• Demonstrated strong knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.

Competencies

• Demonstrates ability to prioritize project responsibilities to meet competing requirements.
• Ability to adapt to change, manage multiple projects effectively meeting timelines.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.
• Able to identify opportunities and implement 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 employee). Additional discretionary incentive cash and stock opportunities may apply. Final compensation is guided by pay equity principles and applicable employment laws.

Benefits

Subject to applicable plans, eligible employees may participate in comprehensive benefits including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees receive Flexible Time Off (FTO) with 11 paid company holidays; non-exempt employees, RayzeBio employees, and Puerto Rico employees 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, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year’s Day.