Manufacturing Associate IV

Position Summary:

ultrainnovative - Tackle rare and dynamic challenges

We are looking for ultrainnovative person to tackle rare and dynamic challenges in an innovative way. The Manufacturing Associate III will be a suite-based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room based position where the Associate 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.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

Training

• Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area. Train less experience operators on the Upstream Process.

• Lead the training of Junior staff.

Quality Systems

• Be able to operate efficiently the Veeva Vault system for all quality documentation.

• Own and rive to closure assigned quality system records.

Documentation

• Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks. 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.

• Review log books and MBRs to allow first time right quality closure.

Plant and Process

• Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available. Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.

• Take the "daily" lead with scheduling and planning all daily activities occurring on the floor.

Miscellaneous

• Ensure high standards of housekeeping are adhered to at all times.

• Attend project and other meetings as required. Ensure effective liaison and communication with other departments, maintaining good relations at all times. Participate in internal/regulatory audits as required.

• Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.

Requirements:

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.

• 5+ years' experience in a Biogics Manufacturing setting

• Experience with viral vectors would be beneficial for this role.

• Ability and desire to work in a fast-paced, start-up environment is essential.

• Strong collaboration, team-working skills and communication skills.

• Independently motivated and detail-oriented with good problem-solving ability.

• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook)

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

• 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. #LI-CK1 #LI-Onsite