Job Description

Job Description

Job Title: Lead Production Technician- Vaccines

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Support the commissioning, set-up, testing, and qualification of new and existing manufacturing equipment.

• Support implementation of Manufacturing Executions System (MES) and electronic batch records (eBR) to optimize control of process management and execution, systems and equipment management, electronic documentation systems, and data historian.

• Design review or testing of single-use bags and components.

• Setup, cleaning, and preparation of the manufacturing space to begin the performance of engineering production runs, and lead to process qualification runs and cGMP commercial production.

• Participate in the execution of Environmental Monitoring Performance Qualification.

• Work collaboratively with engineering, validation, quality assurance, quality control, and manufacturing technology groups as well as external stakeholders to accomplish business needs

• Proactive anticipation and effective communication of successes, constraints, conflicts, solutions, and actions for resolution.

• Write or review standard operating procedures or specific work instructions.

As this project progresses into later phases, the scope of this position will shift to focus on:

• Follow Standard Operating Procedures (SOP) and batch records (BR) to produce commercial drug substance material. May support updates and changes to SOPs and BRs as required.

• Setup, cleaning, sterilization, and use of manufacturing equipment in the cGMP commercial manufacturing of Flublok / Panblok drug substance. May include supporting upstream and/or downstream processes in media or buffer preparation, cell and virus stock production in flasks and bioreactors, centrifugation, chromatography, or filtration; familiarity with this equipment is a plus.

• May include support for cleaning, preparation, and sterilization of equipment and parts.

• Ensures materials required for production are available as needed.

• Support deviation investigations and implementation of corrective and preventive actions

• Support in housekeeping, facility cleaning, daily manufacturing needs, and the overall compliance within the manufacturing groups. Ensures the manufacturing area is in the inspection-read state.

• Provide training, instruction, guidance, and direct support of techniques or operations to operations staff.

• Understands the manufacturing process and the sciences and technology behind process steps, and guides others for further understanding and training.

• Works to resolve all production issues. Involves appropriate management and team to make decisions for the next steps.

• Ensures area staffing provides adequate coverage to required areas.

• Mindful of potential process improvements

• Assists in leading shift change meetings

• Supports off-shift work as needed

The position will be based in Swiftwater PA. The schedule is primarily first shift, plus flexibility outside these hours as necessary.

About You

EDUCATION AND EXPERIENCE REQUIREMENTS INCLUDE:

• HS or Equivalent with a minimum of five years of cGMP or pharmaceutical experience. OR

• Associates degree with a minimum of three years of cGMP or pharmaceutical experience. OR

• Bachelor’s degree with minimum of two years of cGMP or pharmaceutical experience.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

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