Bristol Myers Squibb Senior Manager, Manufacturing, Cell Therapy Manufacturing in Devens, Massachusetts
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.
The Manufacturing team is seeking a Senior 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.
DU TIES 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 andF&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 executesEngineering Runs, Tech Transfer Runs and clinical operations for a new CAR-T product in theDevens CTFManufacturing 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 forAssociates,TeamLeaders, Supervisors and Managers.
Reviewing and approving documents, including standard operating procedures, batch records, material specifications,training materialsand validation protocols / reports.
Education and Experience :
Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred.
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.
12+years ofrelevant work experience within pharmaceutical or a similarly regulated industry
8+ years of directexperience in cGMP biologics manufacturing, experience in cell therapy manufacturingpreferred
6+ years supervising staff in a managementrole
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 ofdecisions
Technical writing capability and experience with writing,approvingand training staff onSOPs, Batch Records, Change Controls, deviations and CAPAs.
Proficient in MS Office applications
Background to include an understanding of biology, chemistry, medical or clinicalpractices
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 matrixedenvironment
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.
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 any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1546762
Updated: 2021-09-22 03:12:29.978 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.