Manager I, Manufacturing Operations

Biopharma Careers; Bothell (WA); On-site; USD 114,000 - 138,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

11 holidays

Job summary

Bristol Myers Squibb is seeking a Manager I, Manufacturing Operations in Bothell, WA to lead cell therapy manufacturing operations within a GMP environment. You will oversee documentation, change controls, training, and continuous improvement initiatives to ensure compliance and performance.

The role requires strong leadership, 5+ years in cGMP cell therapy manufacturing, and experience with aseptic processing.

Qualifications

• Bachelor's degree in a science or engineering discipline.
• 5+ years of experience in cGMP cell therapy manufacturing with leadership responsibilities.
• Experience with cell therapy manufacturing is highly preferred.
• Aseptic processing in ISO 5 biosafety cabinets and handling human materials in controlled areas.

Responsibilities

• Manage creation, implementation and compliance of Source Governing Documents for cell therapy operations.
• Oversee operations within validated manufacturing systems.
• Plan, assign resources and oversee daily activities while controlling costs.
• Maintain compliant, safe and inspection-ready facilities and processes.
• Drive continuous improvement in cost, quality, safety, culture and delivery.
• Lead training and development to ensure staff competency in curricula and GxP requirements.

Skills

Leadership

Compliance awareness

GxP knowledge

Education

Bachelors in relevant science or engineering

Tools

MRB processes

Job description

Position Summary

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”, a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Duties/Responsibilities

• Manages the creation, implementation and compliance of all Source Governing Documents (including but not limited to: Standard Operating Procedures, Work Instructions, Batch Records, Forms) related to cell therapy operations for self and others
• Oversee operations within the requirements of a validated manufacturing system(s)
• Plan, assign resources and oversee daily operational activities associated with assigned areas of responsibility while controlling costs
• Maintain operating and storage areas to ensure that they are compliant, efficient, effective, safe and always inspection ready
• Drives right-first-time initiatives and holds team accountable for compliance performance. Generates solutions for compliance issues.
• Prepares, gains alignment and implements Change Controls
• Completes MRB slides and presents at MRB meetings as needed
• Initiates change controls, notice of events, deviations and investigations and drives actions to closure as assigned
• Evaluates team performance and drives continuous improvement of cost, quality, safety, culture and delivery.
• Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations
• Verify manufacturing associates and team leads are fully trained on respective curricula to maintain compliance prior to performance any GxP task.
• Create an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment, including psychological safety, and the safety of the patients by compliance with company procedures and policies, and cGMP requirements
• Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner and in accordance with schedules and defined implementation timelines
• Presence in the cell therapy manufacturing facility to participate in walk throughs, provide process troubleshooting, participate in event triages, and have direct contact with manufacturing personnel in order to provide timely, effective coaching.
• Oversee operators on daily basis as they: Perform unit and support operations described in Source Governing Documents in a safe and GMP compliant manner
• Complete documentation contemporaneously required by Source Governing Documents.
• Maintain training compliance by completing all training assignments to ensure the necessary technical skills and knowledge
• Assist in the setup of manufacturing areas and equipment/fixtures, facility and equipment commissioning, and qualification and validation activities
• Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Hire, mentor and develop exceptional people. Conduct effective performance reviews with supporting documentation and identify opportunities for career growth for manufacturing associates. Immediately address performance issues through document coaching / feedback as required.

Reporting Relationship

Sr. Manager or Associate Director

Qualifications

• Education: Bachelors in relevant science or engineering discipline, or equivalent in work experience
• Experience: 5+ years of experience in cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience with 2 years leadership experience (i.e. lead or equivalent) including performance management responsibilities is highly desirable
• Experience in the following is highly preferred: Cell therapy manufacturing
• Aseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2/ML-1 containment areas.
• Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and 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 needed), 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 is areas that may have strong magnets.
• Must be able to work in a BSL2 / ML-1 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)
• Schedule: Alternating Wednesdays, Thurs-Sat 0500-1730

Compensation Overview

• Bothell - WA - US: $113,930 - $138,051

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

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.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodations/adjustmentsprior to accepting a job offer. If you require reasonableaccommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1605891 : Manager I, Manufacturing Operations

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