Position Summary:The successful candidate will be 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.
Role & 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. May be assigned to guide others in these activities.
- 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 an 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.
- Demonstrate a 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.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:New Brunswick - NJ - US: $109,270 - $132,407
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our 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), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including 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 enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
