Associate III Manufacturing, Cell Therapy

• Execute operations as outlined in Standard Operating Procedures (SOPs) and batch records
• Executes transactions and process in all electronic systems
• Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Complete training assignments to ensure the necessary technical skills and knowledge
• Train for proficiency in process systems and some supporting business systems
• Work within a controlled cleanroom environment and perform aseptic processing (as assigned; 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
• Able to train new operators
• Role models and leaders for the culture of compliance
• Controlled document & Deviation authoring, change impact assessment and action owner
• Demonstrate a strong practical and theoretical knowledge in their work
• Can represent department in cross-functional department collaborations
• May before Team Lead duties as needed / delegated
• Complete documentation required by governing controlled documents and batch records
• Solve complex technical problems; takes new perspectives using existing solutions
• Train others on SOPs, Work Instructions to successfully complete manufacturing operations

• Associate or bachelor's degree in related field is preferred.
• A minimum high school diploma and/or equivalent combination of education and experience is required.
• MBO 3 of 4 in science related field and/or equivalent
• Experience:
• 3+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• Extensive knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired
• Demonstrated aptitude for engineering principles and manufacturing systems
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications
• Demonstrated good interpersonal skills, is attentive and approachable
• Maintain a professional and productive relationship with area management and co-workers

Preferred Experience:

• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Cell expansion using incubators and single use bioreactors

We will be recruiting 10people for this role.

LI-Onsite

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.