At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Job Summary
Bristol Myers Squibb is seeking a Manager for QC Microbiology at the Cell Therapy Facility (CTF) in Devens, MA. This role will manage the daily operations of the QC Microbiology shift, responsible for environmental/utility monitoring and QC microbiology testing and data review for in-process, release, and stability testing of clinical and commercial cell therapy drug product. The Manager, QC Microbiology will also be responsible for hiring, mentoring and developing the QC Microbiology team to support business operations and employee career development.
Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions. This position directly leads the QC shift and works the following shift schedule:
- PM Shift: Wednesday to Saturday 2 PM 12 AM
This role is stationed in Devens, MA and reports to the Associate Director, QC Microbiology.Job Responsibilities
Qualifications and Education Requirements
- Supervise the QC Microbiology lab staff on shift and oversee the daily lab activities related to environmental/utility monitoring, in-process, final release, and stability testing of cell therapy drug product.
- Develop and execute a work plan for the shift, ensuring safety, quality, and performance targets are achieved.
- Perform QC data review ensuring results are compliant with specifications and regulations. Report abnormalities.
- Track, trend, and report key performance metrics. Drive continuous improvement in the lab to increase productivity and efficiency. May collaborate with other departments to identify and implement process improvements.
- Review and approve test methods and procedures to ensure operational alignment and compliance with corporate policies and procedures.
- Own and evaluate relevant change controls, investigations, deviations, CAPAs.
- Hire, mentor, and develop team members to support the business operations and employee career development.
- Oversee training of the team members.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Responsible for cGMP compliance in all aspects of laboratory operations. Participate in site team supporting and managing regulatory inspections and findings.
- Perform other tasks as assigned.
- Experience with microbiology assays and associated equipment.
- Experience with laboratory LIMS, ELN, 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 assignments while meeting timelines in a GMP environment.
- Advanced ability to work collaboratively in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Excellent organizational and critical thinking skills.
- Advanced problem-solving ability/mentality, technically adept and logical.
- Advanced ability to communicate effectively with peers, department management and cross-functional peers.
- Proficient with Excel, Visio, PowerPoint, and other common software applications.
- Bachelors degree required, preferably in Microbiology or related science.
- 6+ years of relevant laboratory work experience, preferably 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.
If you want to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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