Scientist, QC Compliance, Cell Therapy

At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

Position Summary

Subject matter expert leading and authoring QC deviations laboratory investigations CAPAs and change control. May support authoring of APQR sections for QC.

Duties/Responsibilities

• Subject matter expert leading and authoring QC deviations laboratory investigations CAPAs and change control.
• Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations deviations CAPAs and change controls.
• Generate and report KPIs. Highlight and escalate at risk items. Analyze and report CAPA effectiveness.
• Own document revision project CAPA and deviation/investigation change management and/or continuous improvement efforts.
• Train and mentor others on deviation investigation CAPA and change control process/procedures.
• Represent department in internal/ external inspections.
• May support authoring of APQR sections.
• Communicate effectively with management and cross functional teams (e.g. present investigation findings at governance forums).

Qualifications

Specific Knowledge/Skills/Abilities:

• Ability to accurately and completely understand follow interpret and apply Global Regulatory and cGMP requirements.
• Advance problem-solving ability/mentality critical thinking technically adept and logical.
• Advance ability to communicate effectively with peers department management and cross-functional peers about task status roadblocks and needs.
• Ability to work in a fast-paced team environment action oriented highly organized to meet deadlines and prioritize work.
• Strong mentoring coaching influencing negotiating and personnel interaction skills.

Education/Experience/Licenses/Certifications:

• Bachelors degree in science engineering or related discipline.
• 6 years of experience in biopharmaceutical or QC lab operations with 2 years of prior investigation experience required. An equivalent combination of education and experience may substitute.
• Knowledge of cell therapy analytical and microbiological testing preferred.
• Demonstrated experience with Quality management systems.
• Demonstrated strong technical writing skills.
• Demonstrated experience in laboratory or biomanufacturing. investigations and root cause analysis techniques preferred.

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

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 Years Day.

U.S.-based job seekers can explore full benefit offerings at We Work

Where 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 People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

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