Senior Manager, Manufacturing, Cell Therapy Manufacturing
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.
PURPOSE AND SCOPE OF POSITION:
BMS is seeking a manager of Cell Therapy Manufacturing for a new manufacturing facility in Devens, MA. The Senior Manager will support the scale-up and commercial licensure of the Cell Therapy facility. In addition, the Senior Manager will be responsible for the people manufacturing both clinical and commercial product. This person will be a key leader responsible for GMP. This position will supervise shifts that cover 24/7 cell therapy operations and supervise manufacturing associates and supervisors.
Education and Experience:
- Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred.
- 12+ years of relevant work experience within pharmaceutical or a similarly regulated industry
- 8+ years of direct experience in cGMP biologics manufacturing, experience in cell therapy manufacturing preferred
- 6+ years supervising staff in a management role
- Knowledge of Lean Manufacturing principles required.
- Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
- Ability to work in the vicinity of strong magnets.
Knowledge, Skills, and Abilities:
- Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques
- Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues
- Independent decision-making capability and ability to think conceptually and understand impact of decisions
- Technical writing capability and experience with writing, approving and training staff on SOPs, Batch Records, Change Controls, deviations and CAPAs.
- Proficient in MS Office applications
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
DUTIES AND RESPONSIBILITIES:
Establishes and manages multiple manufacturing teams, shifts and manufacturing areas. This includes:
- Hiring, mentoring and developing exceptional people: Conducting performance reviews and identifying opportunities for career growth for supervisors and associates.
- Championing a culture of exceptional teamwork and communication across the organization.
- Ensuring people have and maintain the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
- Building effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS and F&E.
- Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements. Models these behaviors every day.
Plans for and executes Engineering Runs, Tech Transfer Runs and clinical operations for a new CAR-T product in the Devens CTF Manufacturing Plant. This includes:
- Establishing department goals, tracking and reporting KPIs, and driving a culture continuous improvement through innovation and implementing lean manufacturing initiatives.
- Implementing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
- Building and maintaining a training program for cGMP and manufacturing systems.
- Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity of the facility for multiple CAR-T products.
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
- Ensuring on time closure of deviations, CAPAs, and change controls.
- Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
- Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders, Supervisors and Managers.
- Reviewing and approving documents, including standard operating procedures, batch records, material specifications, training materials and validation protocols / reports.
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.
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