Cryogenic Process Specialist

Bristol Myers Squibb • Devens, MA

5d • Onsite

About The Position

The Cryogenic Process Specialist assists in the execution of drug substance freezing, drug substance shipments, QC sample shipments and cell bank activities according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs). This role consists of performing operational and warehousing activities in the Devens site Cryogenic facility. Activities include the freeze –thaw processing steps and packaging- shipping of bulk drug substances or cold chain samples in accordance with the defined process parameters and the business requirements of the Devens site.

Requirements

• Associate's degree is required.
• A minimum of 4+ years operations experience in a facility subject to Good Manufacturing Practices (GMP) regulations.
• Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP).
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
• Previous work experience where attention to detail and personal accountability were critical to success.
• Demonstrates good interpersonal skills, is attentive and approachable.
• Maintains a professional and productive relationship with area management and co-workers.

Nice To Haves

• Bachelor's degree preferred.
• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, is a plus.

Responsibilities

• Performing operational and warehousing activities in Devens site Cryogenic facility.
• Executing freeze –thaw processing steps and packaging- shipping of bulk drug substances or cold chain samples.
• Adhering to Good Manufacturing Practices and standard operating procedures.
• Working in a safe manner, following all safety processes, procedures and guidelines.
• Maintaining housekeeping and audit readiness at all times.
• Supporting and/or leading deviations and safety investigations related to Cryogenics Process operation.
• Effectively using and possessing mastery for process automation systems (i.e. Delta V, OSI/Pi Historian, and MES Syncade) and supporting business systems (i.e. SAP. Infinity, Maximo etc.).
• Ensuring less experienced personnel comply with Standard Operating Procedures (SOPs) and work instructions and that training is completed on time.
• Revising and creating process documents with no instructions, supporting routine process investigations independently.
• Reviewing batch records for each manufacturing lot in conjunction with Quality representative and resolving issues.
• Championing areas specific initiatives associated with work safety.
• Engaging in and supporting culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
• Advising supervisor on improvements which may optimize work processes.

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.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree