Manufacturing Associate III - Drug Substance Upstream - Gene Therapy (Second Shift 12Pm-12Am)

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

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 III 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.

This is a 12-hour rotation shift 12:00 pm to 12:am - pittman schedule (3 days in, 2 days off, 2 days in, 3 days off) and every other weekend is required.

Work Model:

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

Responsibilities:

• Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area.
• Overseeing and driving their training in the GTMF area to enable them to carry out their duties efficiently and compliantly.
• 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, including deviation follow ups, in a timely manner.
• 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.
• 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.
• Strive to Become a subject matter expert for all "assigned" equipment in the area of control.
• 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.
• Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.
• Ensure high standards of housekeeping are adhered to at all times.
• Participate in internal/regulatory audits as required.
• Attend project and other meetings 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.
• 4-6 years' experience preferably in pharmaceutical manufacturing or other regulated industry coop and internship experience is considered.
• Experience with viral vectors and/or biological processes.
• Strong collaboration, team-working skills and communication skills.
• Ability and desire to work in a fast-paced, start-up environment is essential.
• 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.
• 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). #LI-CS1 #LI-Onsite