Associate I, Manufacturing

About the role

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.

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)
• Execute transactions and process in all electronic systems and adhere to business continuity processes
• Prioritize safety of self and others
• Report safety events within 24 hours
• Immediately escalate 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 necessary technical skills and knowledge
• Train for proficiency in process systems and some supporting business systems
• Execute the daily unit operations schedule, that includes people, product, and material flow across multiple shifts
• Work within a control 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
• Continue to refine and improve manufacturing process technique to improve individual operational times
• Verify training completion prior to performing any GxP tasks
• Author Manufacturing operating procedures that are technically sound, promote effective and efficient operations and comply with cGMP requirements

Qualifications

• 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
• 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education
• Proven experience working on teams where 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 is critical to success
• Possess excellent 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 preferred

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 but 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)

Shifts available

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

Pay

• Bothell - WA - US: $30.61 - $37.09 per hour

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
• Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day

This response is AI-generated, for reference only.