Scientist, QC Microbiology, Cell Therapy
Devens, MA - USA
Job Summary
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 supporting method transfer/validation and routine testing of in-process final product and stability samples. Perform data review/verification complex troubleshooting and method training. Own project document revisions deviations/investigations/CAPA and continuous improvement efforts
Key Responsibilities
Subject matter expert supporting method transfer/verification/ validation and routine testing of in-process final product and stability samples.
Perform review of testing data (e.g. data packets final lot file COA review).
Anticipate and perform complex troubleshooting and problem solving independently.
Perform data verification data review and review of GMP documentation for multiple methods (general and complex) and/or products.
Own project CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
May represent the department in regulatory inspections (internal and external audits).
Train and mentor others on multiple QC test methods processes and procedures.
Cross trained on multiple complex microbiology methods and/or multiple products.
Author and review/ revise technical documents such as test methods SOPs specifications trend reports and/or sample plans as appropriate.
Perform other tasks as assigned.
Qualifications & Experience
Bachelors degree or equivalent required preferably in science. Advanced degree preferred.
6 years of relevant microbiological testing or QC experience or equivalent combination of education and experience preferably in a regulated environment.
Demonstrated experience with microbiological techniques.
Ability to accurately and completely understand follow interpret and apply Global Regulatory and cGMP requirements.
Demonstrated technical writing skills.
High problem-solving ability/mentality technically adept and logical.
Ability to communicate effectively with peers department management and cross-functional peers about task status roadblocks and needs.
Advanced ability to work in a fast-paced team environment meet deadlines and prioritize work from multiple projects.
Advanced knowledge of LIMS ELN and laboratory data analysis systems preferred.
Strong mentoring coaching influencing negotiating and personnel interaction skills.
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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.
Compensation Overview:
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
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R: Scientist QC Microbiology Cell Therapy
Required Experience:
IC
About Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more