Sr. Clinical Manufacturing Associate

Bristol Myers Squibb • Devens, MA

1d • $34 - $41 • Onsite

About The Position

The Senior Clinical Manufacturing Associate brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The Senior Associate must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. The Senior Associate must be enthusiastic, and innovative individuals with a good understanding of good manufacturing practices to support Clinical Manufacturing Start Up activities, and direct manufacturing operations for Clinical Cell Therapy.

Requirements

• Driven and motivated individual to learn and execute Cell Therapy Manufacturing operations.
• 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 working with human blood components.
• Must be able to be in close proximity to strong magnets.
• High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience
• GMP Compliance experience, knowledge of Data Integrity and ALCOA+ principles, and direct application of them.

Nice To Haves

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.
• Must be able to travel to train and develop at other BMS Sites. Travel durations typically a week or less.
• Bachelors in relevant science or engineering discipline is strongly preferred
• Experience in cell therapy manufacturing, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment.
• Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is preferred.

Responsibilities

• Performing Clinical patient process unit operations and supporting operations described in standard operating procedures and batch records.
• Demonstrating strong practical and theoretical knowledge of work
• Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solving simple problems; taking new perspectives using existing solutions
• Identifying innovative solutions
• Performing tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Completing training assignments to ensure the necessary technical skills and knowledge.
• Working in a cleanroom environment and performing aseptic processing; maintaining 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.
• Referencing Batch Records, Standard Operating Procedures and Work Instructions to successfully complete manufacturing operations.
• Assisting in setting up manufacturing areas and equipment/fixtures.
• Perform facility and equipment commissioning activities.
• Supporting development of manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Supporting production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Supporting quality event investigations
• Any related tasks as required to contribute to a new startup facility.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED