Manufacturing Associate II

Position Summary 

Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.  

BMS Values  

• Our values move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.  

• Candidates must exemplify the BMS values of Passion, Integrity, Inclusion, Accountability, Innovation, and Urgency.

Duties/Responsibilities  

• Learn and execute Cell Therapy Manufacturing operations compliantly  

• Execute operations as outlined in Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)  

• Demonstrate strong practical and theoretical knowledge  

• Executes transactions and process in all electronic systems and adheres to business continuity processes  

• Prioritizes safety of self and others  

• Reports safety events within 24 hours  

• Immediately escalates any/all issues that may impact compliance or safety of self and/or others.  

• Complete documentation required by Source Governing Documents contemporaneously  

• Perform all tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+  

• Complete training assignments prior to assigned due date to ensure the necessary technical skills and knowledge  

• Trains for proficiency in process systems and some supporting business systems, and maintains trainer qualifications  

• Collaborate with support groups on recommendations and solving technical and operational problems  

• Train others on Source Governing Documents to successfully complete manufacturing operations  

• Execute daily unit operations schedule, that includes people, product, and material flow across multiple shifts  

• Work within a controlled cleanroom environment and execute aseptic processing procedures (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  

• Continues to refine and improve manufacturing process technique to improve individual operational times.  

• Verifies training completion prior to performing any GxP tasks 

Reporting Relationship 

• Reports to Manager, Manufacturing Operations 

Qualifications 

Education:  

U.S.  

• 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  

Netherlands  

• MBO, 3 of 4 in science related field and/or equivalent  

Experience:  

• 1+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education  

• Proven experience working on teams where combined contribution, collaboration, and results were expected  

• Proficiency in common computer tools such as word processing, spreadsheet and web-based applications  

• Meticulous attention to detail and personal accountability are critical to success  

• Demonstrated good interpersonal skills, is attentive and approachable  

• Maintain a professional and productive relationship with area management and co-workers  

• Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is required  

Preferred Experience:  

• Experience in cell therapy manufacturing, including Cell washing, Cell Expansion processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.  

Working Conditions:  

• Must be able to stand/walk for extended periods of time  

• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets (as assigned), which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.  

• Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials  

• Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials  

• Work in areas that may have strong magnets 

• Must be able to work in a BSL2 / ML1 work environment handling human blood components Work in areas with exposure to vapor phase liquid nitrogen  

• Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)  

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.  

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. 

Shifts available:

Days – Sun – Tue (alt. Wed) 0500 – 1730

Days – Thu – Sat (alt. Wed) 0500 – 1730

Swing – Sun – Tue (alt. Wed) 1100 – 2330

Swing – Thu – Sat (alt. Wed) 1100 - 2330

BMSCART

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