Bristol Myers Squibb Director of 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 Director will lead clinical and commercial manufacturing in the Devens Cell Therapy manufacturing facility. In addition, the Director will be responsible for the execution of Technical Transfer and for building and leading the manufacturing organization in a 24/7 operation. This person will be a key leader for GMP operations and will serve as a member of the Cell Therapy Manufacturing Leadership Team
DUTIES AND RESPONSIBILITIES:
Build and manage the Cell Therapy Manufacturing team, including:
Hiring, mentoring and developing exceptional people. This includes conducting performance reviews and identifying opportunities for career growth for Managers, Supervisors and Associates.
Championing a culture of exceptional teamwork, accountability, urgency, and communication across the organization. Role model of the BMS values.
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, HS and Facilities.
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.
Participate in the tech transfer, startup and operation of the CT Manufacturing Suites, including:
Establishing goals, tracking and reporting KPIs, and driving continuous improvement through innovation and implementing lean manufacturing initiatives.
Support the completion of the facility construction, including detailed design, commissioning, qualification and validation.
Building and implementing operating manufacturing systems that are technically sound, promote effective and efficient operations and comply with cGMP requirements.
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.
Successfully completing facility PPQ.
Ensuring on time closure of deviations, CAPAs and change controls
Championing pre-license inspection readiness efforts and initiatives for Right First Time manufacturing.
Establishing team policies, organizational structures, shift structure and career ladders for Associates, Team Leaders and Managers dedicated to the specific suites.
Reviewing and approving documents, including standard operating procedures, batch records, material specifications and validation protocols/reports.
Up to 10% travel may be required
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Bachelor’s degree in relevant science or engineering discipline. Advanced degree preferred.
Experience with process transfers leading to commercial licensure required
Knowledge of Lean Manufacturing principles required. Black Belt certification a plus.
8-12 years of experience in cGMP biologics manufacturing, some experience in cell therapy manufacturing preferred.
8+ years supervising staff in a biopharmaceutical operations role.
Advanced understanding and experience with cell culture, cryopreservation, purification and aseptic processing.
Knowledge of cGMP/FDA regulated industry, along with experience and Agency interactions and inspections.
Experience with reviewing and approving SOPs, Batch Records, Change Controls, deviations and CAPAs.
Proficient in MS Office applications
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.
Company: Bristol Myers Squibb
Req Number: R1528755-en-us
Updated: 2020-12-01 00:49:26.198 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.
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