Lead Production Technician

Lead Production Technician

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. This position 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.

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.

Production & Manufacturing Operations

• 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.

Quality, Compliance & Documentation

• 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.

Leadership, Subject Matter Expertise & Continuous Improvement

• 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 for scheduling staff assignments and addressing inquiries related to media, reagents, supplies, intermediates, and equipment.
• Understands the entire manufacturing process, including the sciences and technologies behind each process step, and demonstrates follow-through in moving processes forward.
• Is aware of other departments and business areas and how they contribute to the overall objective of delivering products and services.

Training & Development

• Provides training, instruction, guidance, and direct technical support to operations staff on proper work procedures, equipment use, cGMPs, safe work techniques, and ERP systems; ensures timely signoffs and consistency in training across B55 areas.
• Maintains qualified trainer status.
• Completes at least one developmental class annually outside of core competencies and works to complete all assigned training modules.
• Works with management to identify development opportunities for technician staff.

Safety

• Follows all safety procedures to ensure personal safety and the safety of others; participates in monthly safety meetings and actively engages in safety walkthroughs.
• Reports all safety issues, concerns, incidents, and near misses to team leadership.
• Provides input on potential safety issues and contributes ideas for corrective and preventative actions.
• Works with the safety and leadership team to secure resources needed to address safety issues in a timely manner and to implement effective resolutions.
• Actively and effectively communicates safety initiatives and helps others understand and comply with them; ensures training is completed on all safety implementations.
• Ensures compliance with site safety and HR policies and communicates issues immediately.
• All other duties as assigned.

About You

Basic Qualifications:

• HS equiv or Associates with 4+ years in manufacturing or Pharmaceutical experience
• Bachelor's with 1+ years in manufacturing or Pharmaceutical experience

Preferred Qualifications:

• Prior or related cGMP, Pharmaceutical, or other industrial quality management experience
• Proficiency in any of the following areas preferred: Batch record review, environmental monitoring, logbook review, technical writing, SAP, PI historian.
• Requires good mechanical skills, computer skills and is detail-oriented. Must have basic mechanical aptitude, good comprehension skills, retention skills, troubleshooting, and manual dexterity.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.