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Manager, Quality Control Sample Management in Devens, MA

Manager, Quality Control Sample Management in Devens, MA

Massachusetts StaffingDevens, MA, US
Hace 6 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Manager, Qc Sample Management

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

Bristol Myers Squibb is seeking a Manager, QC Sample Management at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Sample Management shift, responsible for the management of QC samples and materials in support of the QC laboratories. This includes, but is not limited to, mentoring, training and managing the QC Sample Management team, maintaining and tracking testing samples, retains, scheduling lab operations, supporting lot release, creating and continuously improving processes, reviewing and approving documents, and overseeing sample tracking, delivery, and destruction. This role works from 6AM to 6PM following a 12-hour rotating shift (36 / 48 hours over a 2-week period) which includes working every other weekend, holidays falling on scheduled workdays, and during adverse weather conditions in support of QC and the manufacturing facility. Flexibility to work irregular hours and short notice overtime may be required.

Responsibilities :

  • Provide supervision of QC Sample Management shift and oversee the daily Sample Management activities related to in-process, final release and stability testing of cell therapy drug product.
  • Develop and manage a daily work plan for QC associates. Report out quality and operational metrics.
  • Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required.
  • Hire, mentor and develop the team members to support the business operations and employee career development.
  • Oversee the training of the team members.
  • Review and approve procedures for Sample Management activities.
  • Collaborate with other departments to identify and implement process improvements.
  • Own and evaluate relevant change controls, investigations, deviations, CAPAs.
  • Apply critical thinking skills when working on new procedures or process improvements.
  • Communicate effectively with management regarding task completion, roadblocks, and needs.
  • Perform other tasks as assigned.

Knowledge, Skills, Abilities :

  • Experience with cold chain sample storage and transfer in a GMP regulated environment.
  • Familiar with Excel, Visio, Power Point, and other software systems.
  • Experience with laboratory LIMS and ERP systems (e.g., SAP) preferred.
  • Ability to work in a highly regulated environment and follow regulatory requirements and GMPs.
  • Ability to mentor associates, manage multiple assignment while meeting timelines in a GMP environment.
  • Advanced ability to work in a collaborative team environment and train others.
  • Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
  • Excellent organizational and critical thinking skills.
  • Advanced ability to communicate effectively with peers, department management and cross-functional peers.
  • Basic Requirements :

  • Bachelor's degree required, preferably in Chemistry, Microbiology or related science.
  • 6+ years of relevant work experience, preferable in a regulated environment.
  • 2+ years of management and people leader experience.
  • An equivalent combination of education and experience may substitute.
  • The incumbent will be working around biohazardous materials.
  • The incumbent may be exposed to fluctuating and / or extreme temperatures on occasion.
  • If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview : Devens - MA - US : $99,380 - $120,428. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role : Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit https : / / careers.bms.com / eeo-accessibility to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for

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    Quality Control Manager • Devens, MA, US

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