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PREP Filling Manager (Vaccines)

Swiftwater, Pennsylvania

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Overview

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.

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Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Results-driven
  • Proactive
  • Problem-Solver
  • Leadership
  • Team player

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Culture: Play to Win

  • Woman looking through a microscope

    Growth

  • Scientists discussing lab work

    Innovation

  • Doctor using new technology

    Efficiency

  • Woman using dry eraser marker drawing up business plans on glass

    Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"Working at Sanofi I have a career not just a job."

DAN MOORE Global Project Manager

"Working here I feel valued and empowered to do my best. I am proud to be part of a team dedicated to driving change to help save the lives of our patients."

RAQUEL REYES Biological Sales Program

"Working at Sanofi YOU own your career. Where you go is up to you!"

LUCAS GEORGE Director of Viral Manufacturing - Biologics

Responsibilities

Shift Schedule: 1st Shift, Sunday-Thursday or Tuesday-Saturday
Role Title: PREP Filling Manager

Role Responsibilities

Safety:

  • Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings

  • Reports all safety issues, concerns, incidents and near misses to the team leadership

  • Actively participates in safety walkthroughs coordinated by the department’s safety team

  • Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions

  • Follows effective procedures to ensure the production of a safe and efficacious product.

  • Utilizes +QDCI boards for Safety issues

Quality:

  • Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections

  • Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies

  • Supports SGS meetings and proactively addresses observations

  • Conducts real time reviews to assess aseptic performance, GMP data entries, and all metrics are accurately updated

  • Understands the function of the quality group and works with them to maintain a positive rapport.

Delivery:

  • Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.

  • Follows escalation procedures to mitigate any variables negatively impacting eOEE.

  • Reviews eOEE metrics throughout shift to ensure proper categorization of downtime.

  • Ensure training of personnel is assigned and entered as needed in order to support business needs.

  • All other duties as assigned. Adheres to all other company time keeping and attendance policies.

Cost:

  • Executes procedure as documented to avoid deviations.

  • Ensure training methodologies are implemented to improve operator efficiencies.

  • Supports all changeover related functions to achieve eOEE standard.

Involvement:

  • Works to become trained in all assigned training modules.

  • Trains and orients new team members (at any level) as assigned. 

  • Participates and leads team meetings.  Understands respect, professionalism and confidentiality.

  • Ensures Training coordinator / Trainers, train and guide personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques, and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

Preferred Qualifications

  • Must be very detail-oriented and organized with excellent time-management skills

  • Strong analytic and problem-solving abilities, as well as the flexibility to change and adapt as the job grows and develops

  • Excellent verbal and written communication, interpersonal and presentation skills, as well as the ability to interact tactfully and effectively with employees at all levels of the organizational structure

  • Intermediate proficiency in MS Office Suite

  • Working knowledge of SAP preferred

  • Lean manufacturing preferred

Minimum Requirements

  • BS degree in Life Sciences, Engineering or equivalent with relevant experience in manufacturing and/or filling of biological products or 7+ years relevant experience in manufacturing and/or filling of biological products

  • 3-5 years' experience in manufacturing and/or development departments

  • Must have previous experience in working with a production department of a pharmaceutical company.

  • Experience in FDA Regulated Industry

  • Working knowledge of cGMP's

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

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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PDN

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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