About this role
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
The Manager, Cell Therapy Manufacturing supports the commercial operations of the facility. The Manager will be responsible for the people manufacturing both clinical and commercial product with oversight of shifts that cover 24/7 cell therapy manufacturing unit operations such as media preparation, cell selection, cell processing, or product fill, all of which are executed in accordance with Current Good Manufacturing Practices (cGMP’s).
Shifts Available
6am – 6pm, rotating schedule including holidays and weekends
Responsibilities
Supporting the development, implementation and compliance of manufacturing documentation, procedures and policies.
Operating within the requirements of a validated manufacturing systems, plan, assign and oversee daily operational activities associated with assigned areas of responsibility.
Maintaining operating and storage areas that are compliant, efficient, effective and safe.
Identifying strategic and operational issues to prevent deviations and maintain a compliant environment. Leading and managing the development of corrective and preventative actions, deviation responses and investigations.
Creating 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 coordinating, communicating, and providing 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 timelines.
Overseeing 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.
Hiring, mentoring and developing exceptional people
Conducting performance reviews and identifying opportunities for career growth for manufacturing associates.
Working Conditions
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.
Additional Qualifications/Responsibilities
Knowledge, Skills & Abilities
Experience in cell therapy manufacturing techniques, including cell washing processes, cell separation processes, cryopreservation processes, cell expansion processes using incubators and bioreactors, and automated equipment is highly preferred.
Experience with aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL-2 containment areas is highly preferred.
Minimum Requirements
5+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
Bachelors in relevant science or engineering discipline, or equivalent in work experience.
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Compensation Overview
Devens - MA - US: $104,975 - $127,205