Lead Production Technician

Job title: Lead Production Technician

Location: Swiftwater, PA

Shift: 3rd Shift

This position is to become part of the Recombinant Manufacturing Team to support the engineering, construction, qualification, validation, and commercialization of the B55 Recombinant Manufacturing Facility. The role contributes as a member of a cross‑functional team to support the startup of the cGMP manufacturing facility for Flublok /Panblok drug substance in Swiftwater, PA and continue to support the cGMP commercial.

Sanofi is seeking a motivated professional candidate to operate within Biologics production and perform manufacturing activities. The production technician will operate in a cGMP manufacturing area performing equipment set up and operations tasks to meet all standards for safety, quality, and efficiency. The candidate will perform production in accordance with volume fluctuation, business need, and effective procedures.

The Lead Manufacturing Technician is a technical contributor to Flublok/Panblok manufacturing operations. This role is responsible for supporting the cGMP manufacturing facility for Flublok/Panblok drug substance in Swiftwater, PA and will continue to support cGMP commercial manufacturing of drug substances. This role contributes to the overall safety, quality, compliance, productivity, and performance of the Sanofi/Protein Sciences Manufacturing group.

• Follows SOPs and Batch Records (BRs) to produce commercial drug substance material; supports updates and revisions to these documents as required.
• Performs setup, cleaning, and operation of manufacturing equipment in a cGMP environment for Flublok/Panblok drug substance, including upstream and/or downstream processes such as media and buffer preparation, cell and virus stock production in flasks and bioreactors, centrifugation, chromatography, and filtration.
• Ensures all materials required for production are available prior to need and that the team is planning and working ahead according to the B55 production schedule.
• Participates in or leads all aspects of the production process utilizing systems such as iShift, LIMS, Trackwise, Labwatch, Documentum, Metasys, DeltaV, and ERP (including ordering, cycle counting, and inventory transactions).
• Continually monitors production activities with emphasis on safety, quality, efficiency, and cost.
• Supports housekeeping, facility cleaning, and daily manufacturing needs to ensure the manufacturing area remains in an inspection‑ready state.
• Supports off‑shift work as needed.

• Maintains thorough knowledge of cGMP requirements and works to help others understand and apply them.
• Accurately and timely completes quality documentation including eBRs, logbooks, deviation investigations, and other required records; reviews documentation for completeness and releases commodities as required.
• Ensures sampling and corresponding documentation are completed as required.
• Identifies deviations, aids in investigations, and performs root cause analysis; ensures implementation of effective corrective and preventative actions (CAPAs).
• Works with the Quality and Technical Services groups to ensure timely completion of deviation investigations, change controls, documentation, and CAPAs.
• Initiates change controls and CAPAs and follows them through to completion.
• Writes, reviews, and revises eBRs, SOPs, and SWIs as needed.
• Supports CFR (Code of Federal Regulations) compliance, FDA audit readiness, and Pre‑Approval Inspection (PAI) preparedness.

• Serves as Lead Operator, Room Lead, or Subject Matter Expert (SME), ensuring quality and right‑first‑time efforts across one or more processing areas in B55.
• Resolves production issues, understands next steps, and guides the team through completion; informs management of production problems and recommends solutions.
• Identifies areas of deficiency and opportunities for continuous incremental improvement, with emphasis on reducing operator errors.
• Systematically breaks down problems using proven standard approaches.
• May be responsible…