Manufacturing Associate Level 2 - Cell Therapy
United States, Portsmouth (New Hampshire)
The Manufacturing Associate, Level II, will help to provide a safe, controlled work environment in all areas of expertise. Be aware of the site safety objectives and make sure they are communicated and understood. Manufacturing Associate, Level III, will be proficient for an assigned project and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.). Work with customer SMEs to transfer in and maintain customers' processes in production facility. Provide/Arrange effective trainings for manufacturing staff related to any new equipment or systems to be used in Cell Therapy. Collaborate with CT Manufacturing Leadership team to incorporate process and operational improvements into new customer processes in manufacturing. Collaborate with CT Manufacturing Leadership team to determine equipment and materials the suite will need to purchase in order to run the process. May act as a lead role in the absence of the Senior Manufacturing Associate.
Support the definition and execution of Operational Readiness Activity for the Cell Therapy projects at LPO to include:
- Set up of manufacturing procedures & collaboration with QA to support CT quality systems aligned with existing operations & finished dose requirements.
- Support building & establishing the manufacturing team by participating in the interview, onboarding and training of new colleagues.
- Support the delivery of clinical & commercial material as required.
- Support the development and execution of appropriate Safety, Training, Gowning, Material Movement, Visual Inspection, APS, Cleaning, Scheduling, and EM strategies.
- Support the definition and execution of all activity in compliance with EHS requirements.
Support the definition and execution of Technical Transfer activities for CT projects at LPO to include.
- Operational input into material requirements, process execution & methods transfer.
- Operational input into defining & executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.
- Enable timely delivery of milestones for the Technical Transfer.
- Author, review, and approve documentation (electronic batch records, SOPs, WIs, and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.
As project contributor collaborate with CT Manufacturing Leadership Team to ensure.
- Timely tracking of relevant project metrics
- Progression of necessary purchase requisitions/orders and tracking through delivery
- Appropriate interaction with assigned external (customer) and internal stakeholders.
Perform other duties as assigned.
Minimum Required Qualifications/Skills:
- High School diploma or equivalent required. BS preferred, additional experience in lieu of degree considered
- Knowledge of cGMP practices preferred
- Basic principles of hygienic practices and microbiology preferred
- Familiarity with use of computers
- Proactive communication
- Experience with processing in a cleanroom environment
- Ability to follow and comply with detailed procedures
- Experience of biological manufacturing operations preferred.
- Ability to work inter and intra-departmentally and potentially with customers. Ability to work in a team environment. Ability to strive in stressful situations.