NIGHT SHIFT Specialist, Lead Manufacturing Associate
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.
At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.
BMS Cell Therapy Manufacturing seeks a Specialist Lead Manufacturing Associate Cell Therapy that brings enthusiasm intellectual curiosity scientific rigor and a desire to help drive novel programs. The candidate must be goal-oriented flexible and able to work efficiently with safety and quality in mind. We are searching for enthusiastic and innovative individuals with a good understanding of good manufacturing practices to support routine manufacturing operations for Cell Therapy.
Shifts Available:
Night Shift (6pm 6am)
Rotational schedule including holidays and weekends onsite
Responsibilities:
- Execute operations described in standard operating procedures and batch records.
- Demonstrates strong practical and theoretical knowledge in their work.
- Completes documentation required by process transfer protocols validation protocols standard operating procedures and batch records.
- Solves complex problems; takes new perspectives using existing solutions.
- Performs tasks in a manner consistent with the safety policies quality systems and GMP requirements. Completing training assignments to ensure the necessary technical skills and knowledge.
- Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
- Collaborates with support groups on recommendations and solving technical problems.
- Help to ensure the shift works effectively in a team based cross-functional environment to complete all production tasks required by shift schedule.
- Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status.
- Supports investigations.
- Identifies innovative solutions.
- Supports writing manufacturing operating procedures that are technically sound promote effective and efficient operations and comply with cGMP requirements.
- Training others on SOPs Work Instructions to successfully complete manufacturing operations.
- Working with production planning with leadership to execute daily unit operations schedule that includes people product and material flow across multiple shifts.
- Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
Knowledge and Skills:
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Must have the ability to work assigned shift (Day Night Weekends and/or Holidays).
- Must be able to work in a cleanroom environment and perform aseptic processing
- Must be comfortable being exposed to human blood components.
- Must be able to be in close proximity to strong magnets.
- Experience in cell therapy manufacturing including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
- Experience in the following preferred: Aseptic processing in ISO 5 biosafety cabinets universal precautions for handling human derived materials in BSL-2 containment areas.
- Cell expansion using incubators and single use bioreactors
Basic Requirements:
- 4 years of experience in cGMP bioprocessing manufacturing cell therapy manufacturing or relevant experience
- Bachelors in relevant science or engineering discipline or equivalent in work experience.
Working Conditions:
- Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time throughout the day.
- Carrying weight Pushing Pulling Lifting - Required to carry lift push and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
- Climb - Required to climb (use of stepladders in production areas or stairwells) several times a day.
- Bend and Kneel - Required to bend or kneel several times a day.
- Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day throughout the day.
- Moving Head and Neck Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day throughout the day.
- Twisting - Required movement of twisting waist while setting up equipment several times a day throughout the day.
- Repetitive Use - Required repetitive use of arms/wrists/hands while setting up equipment and processing several times a day throughout the day.
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include but not limited to: safety shoes safety glasses aprons face shields lab coats full body gowns hairnets gloves and hearing protection.
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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
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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R: NIGHT SHIFT: Specialist Lead Manufacturing Associate
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