Manufacturing Associate II, Upstream (7am to 7pm Pitman Rotation)

Position Summary:

The Manufacturing Associate II will be a suite based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room based position where the Associate II position will be an on the floor technician assigned to the Upstream Manufacturing area. Expertise will include all cell thaw and culture activities through the various scale of bioreactors up to 2000L and harvest operations

ultrafocused – Work together to fearlessly uncover new possibilities

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. Quality Systems

• Be able to operate efficiently the Veeva Vault system for all quality documentation
• Ensure that high standards of cGMP are adhered to at all times
• Carry out the manufacturing review of the completed batch records in a timely manner per established targets
• Assist in Lot Disposition activities as required, including deviation follow ups, comment resolution in a timely manner to adhere to lot release timing

2. Documentation

• Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks
• Support the completion of change control forms and Deviations, plus subsequent implementation of changes and follow up actions
• Ensure that high standards of cGMP documentation completion are adhered to at all times and documentation is left in a reviewable condition at all times

3. Plant and Process

• Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process
• Ongoing maintenance of own training, ensuring full training has taken place to support the execution of production activities
• Identify and drive any continuous Improvements to the process/equipment

4. Batch Ownership

• Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate
• Initiation of MFG related Quality Incidents as required
• Support/ Drive through to completion any projects as required

5. Miscellaneous

• Ensure high standards of housekeeping are adhered to at all times
• Participate in internal/regulatory audits as required
• Ensure effective liaison and communication with other departments, maintaining good relations at all times
• Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite. Ensure that objectives given are met in the appropriate agreed to timescale

Requirements:

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience
• 2+ years experience in a Biologics Manufacturing setting
• Experience with viral vectors would be beneficial for this role 

Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment
• Certain tasks may require the use of a respirator; medical clearance will be required in advance
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment
• Working in temperature-controlled environments (cold rooms)

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