Team Lead, Manufacturing Associate *PC 1509

Your Role:

This position is responsible for manufacturing biologics (LV) under cGMP conditions.  Staff must follow established procedures, execute batch production records using good documentation practices and adhere to gowning procedures required for work in cleanroom environment.

Provides technical and operational leadership, assists Department head to ensure on time execution of operations.

Essential Duties and Responsibilities:

• Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.


• Execute manufacturing process by batch record instructions and perform GMP documentation review to ensure completeness and accuracy.


• Assist Manufacturing Supervisors in managing daily production activities.


• Works with MS&T, Manufacturing Supervisors and the Manufacturing team to provide technical, process and equipment knowledge in resolving issues and deviations.


• Assists Supervisors in scheduling and resource allocation for daily work, requests materials and consumables for manufacturing.


• Conduct Manufacturing training for new team members.


• Lead in authoring, reviewing and execution of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs), Change Controls, Deviation Investigations.


• Responsible for the cleaning of equipment, cleaning of work areas, maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies.    

Requirements: 

• High School Diploma; 4+ years of related experience.


• Previous GMP and aseptic technique experience is desired.

Skills:

• Ability to articulate with production equipment and / or manufacturing process problems.


• Able to provide detailed communication to multiple departments.


• Excellent computer skills


• Strong verbal and written communication skills.


• Must have a Quality and safety mindset and be a fast learner.

Physical Demands:

• Good eye/hand coordination


• Use keyboard/computer/phone


• Detect/Distinguish hearing


• Position self to move


• Calibrate precise measurements


• Move/Transport 15 kg


• Visual Acuity


• Detect/Distinguish smell


• Maintain stationary position  


• Move/Traverse


• Reaching


• Ability to safely operate hand tools


• Repetitive movement activities

Work Environment: 

• Regular and predictable attendance


• Work irregular hours that often include nights and weekends


• Work in multiple locations


• The role will most likely transition from 5 - 8 hour shifts to 4 - 10 hour shifts late in 2027.