Specialist, Lead Clinical Manufacturing Associate, Cell Therapy in Devens, MA

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profile Job Location:

Devens, MA - USA

profile Monthly Salary: Not Disclosed
Posted on: 4 days ago
Vacancies: 1 Vacancy

Job Summary

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: 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 is seeking a Specialist Lead Clinical Manufacturing Associate Cell Therapy that bring 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 start up activities and routine manufacturing operations for Cell Therapy. This role is key to start up of Clinical Trials at Devens in a multi-product Cell Therapy Facility.

Shifts Available:

TBD

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 Skills Abilities:

  • 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.

Preferred Qualifications:

  • 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.

Physical Demands:

  • 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.

BMSCART

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Devens - MA - US: $91190 - $110498

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.


Required Experience:

IC

Working with UsChallenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthrou...
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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

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