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 whiledemonstratingsafety, quality, and GMP complianceat all times.

BMS Values

• Our values move us toward our mission to discover, developand 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 (includingbut not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms)

• Demonstrate strong practical and theoretical knowledge

• Executes transactions andprocessin all electronic systems and adheres tobusiness continuity processes

• Prioritizes safety of self and others

• Reportssafety events within 24 hours

• Immediatelyescalatesany/all issues that mayimpactcompliance or safety ofself and/orothers.

• Complete documentation required by Source Governing Documentscontemporaneously

• Perform alltasks in a mannerconsistent with the safety policies, SOPs, quality systems, and GMP requirements including ALCOA+

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

• Trains forproficiencyin process systems and some supporting businesssystems, andmaintainstrainer qualifications

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

• Train others on Source Governing Documents to successfully completemanufacturing operations

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

• Work within a controlled cleanroom environment and execute asepticprocessing procedures (as assigned). Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels percontrolled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements

• Continues to refine and improve manufacturing processtechniquetoimprove individual operational times.

• Verifies training completion prior to performing anyGxPtasks

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 isrequired

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

•Proficiencyin common computer tools such as word processing, spreadsheetand web-based applications

• Meticulous attention to detail and personal accountabilityarecritical to success

•Demonstratedgood interpersonal skills, is attentive and approachable

•Maintaina 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 isrequired

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/orlift upto 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, Weekendsand/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 notstateor 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 willbe requiredto 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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