Senior Bioprocess Associate I

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

POSITION SUMMARY:

The primary role of the Senior Bioprocess Associate I is following detailed procedures and batch records ensuring compliance with cGMP and safety requirements. The Senior Bioprocess Associate I 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 I is a senior member of a team and will be leveraged to ensure compliance with cGMP requirements, safety, and production schedule of junior staff.

Duties/Responsibilities:


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.


QUALIFICATIONS

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.


Education/Experience/ Licenses/Certifications:

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 3 years process operations experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations.

Physical Demands:

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.

Work Environment:

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.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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