Senior Bioprocess Associate II - Purification Green Team
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The primary role of the Senior Bioprocess Associate II is following detailed procedures and batch records ensuring compliance with cGMP and safety requirements. The Senior Bioprocess Associate II works on assignments that are moderately complex in nature, where judgment is required in resolving problems and making routine recommendations. Work is performed in a team environment within a medium-scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). Additional gowning through the processing areas and maintaining clean hygiene is a requirement to control established environmental specifications. The Senior Bioprocess Associate II is a senior member of a team and will be leveraged to ensure compliance with cGMP requirements, safety, and production schedule of junior staff. When required, the Senior Bioprocess Associate II will serve as temporary Shift Supervisor.
• Operates control systems and processes supporting biologics process manufacturing.
• Operates all production equipment within the assigned functional area (i.e. media formulation equipment, glass washers, bioreactors, harvest equipment, buffer equipment, chromatography skids, membrane operations, column packing skids, aseptic handling of mammalian cell culture, aseptic filling of final drug substance, conducting scale-up operations, etc.)
• Maintains files, records data, logs activities, and monitors processes.
• Prepares process buffers, media and reagents.
• Cleans and Steam sterilizes equipment and maintains area in a clean and orderly fashion to support the manufacturing schedule.
• Recognizes and reports safety, maintenance and quality events to area management.
• Communicates status of operations to area management in a timely manner.
• Achieves and maintains proficiency through training.
• Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative.
• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
• Champions areas specific initiatives associated with work safety
• Serve as designee for Shift Supervisor as required (duties including but not limited to: daily task assignment, investigational support, project schedule and maintenance coordination)
Specific Knowledge, Skills, Abilities, etc:
• Prior job related experience required along with demonstrated mechanical aptitude and high level of attention to detail.
• Prior process operations experience in a biotechnology manufacturing facility or related industry subject to current Good Manufacturing Practices (cGMP) regulations.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
• Practical knowledge of regulations such as cGMP and Standard Operating Procedures (SOP).
• Familiarity with general chemistry, mathematics, microbiology and cGMP operations is desirable.
• Work/study experience where attention to detail, adherence to written instruction, and personal accountability were critical to success
• Demonstrated abilities for problem solving, successful participation on work teams where combined contribution, collaboration, and results were expected
• Demonstrates good interpersonal skills, is attentive and approachable with the ability to embrace a team based culture.
• Demonstrated ability to communicate expectations and results to the operating staff and management as needed to maintain production timelines and organizational goals.
• Demonstrated ability to lead a positive, collaborative, inclusive environment to achieve team goals.
The successful candidate will have a high school diploma. Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline or its equivalent is desired. Experience in aseptic technique and mammalian cell culture is desired A minimum of 4 years process operations experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations.
This position is located a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). This role will require contact with hazardous materials such as caustic, acids and steam. Frequent bending, twisting, squatting, kneeling, climbing and reaching is required. Role also requires infrequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hand/wrists, grasping is also required. This position is a team based position that requires shift work, weekends, holidays and overtime.
The work environment involves activities in a medium scale manufacturing facility, lab space and office space. The environment includes limited exposure to noise ( > 85 dBA), hazardous chemicals and equipment temperature extremes.
• This position requires up to _0_% of travel
In the absence of a shift supervisor this role may require temporary assignment of some supervisory duties such as task assignment, real time review, and direct interaction with EHS, Quality and Maintenance.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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