Manufacturing Operations Manager, Cell Therapy

Company: Celgene
Location: Ayer
Posted on: November 21, 2022

Job Description:

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 Manager will support the start-up and commercial licensure of the Cell Therapy facility.This Manager will be responsible for shifts that cover 24/7 cell therapy operations and will manage manufacturing associates.DUTIES AND RESPONSIBILITIES:Manage the creation, implementation and compliance for all documentation, procedures and policiesOperate within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility.Maintain operating and storage areas that are compliant, efficient, effective and safe.Identify strategic and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation responses and investigations.Manage implementation and maintenance of appropriate training curriculaCreate an environment of teamwork, open communication, and a sense of urgency. Foster a culture of safety and compliance that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.Efficiently coordinate, communicate, and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated functions in a timely manner in accordance to schedules and defined implementation timelinesOversee operators on daily basis as they:Perform unit operations and support operations described in standard operating procedures and batch records in a safe and GMP compliant manner.Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.Maintain training assignments to ensure the necessary technical skills and knowledge.Assist in the setup of manufacturing areas and equipment/fixtures and perform facility and equipment commissioning, qualification and validation activities.Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirementsHire, mentor and develop exceptional people: Conduct performance reviews and identify opportunities for career growth for manufacturing associates.This position will require shift work, including holidays and weekends.This position will require you to work in a clean room environment, with exposure to human blood components and in close proximity to strong magnets.REQUIRED COMPETENCIES:Knowledge, Skills, and Abilities:Bachelors in relevant science or engineering discipline, or equivalent in work experience.5+ years of experience in cGMP biologics cell culture manufacturingExperience in the following is highly preferred:Cell therapy manufacturingAseptic processing in ISO 5 biosafety cabinets and universal precautions for handling human derived materials in BSL-2 containment areas.Cell expansion using incubators and single use bioreactors, Cell washing processes, Cell separation techniques and cryopreservation processes and equipment.BMSCART VETERANAround 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.

Keywords: Celgene, Nashua , Manufacturing Operations Manager, Cell Therapy, Executive , Ayer, New Hampshire