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Manager Manufacturing Staff US-3rd Shift(10:00 pm-6:30 am)-Swiftwater, PA

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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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

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

Manufacturing Manager - 3rd shift (10 pm-6:30 am) - Swiftwater, PA

Position Summary:

Responsible for supervising commercial manufacturing operations. Ensure production operations are conducted in accordance with regulatory and cGMP compliance, while delivering to the production plan of record. Instill a culture of continuous improvement within production operations, and foster team growth environment. Collaborate with Regulatory/Quality, Facilities, and Development with regards to project plans and the successful production execution of sustainable commercial manufacturing activities.

Essential Duties and Responsibilities:

This position is designated for a Production Manager in the Antigen Manufacturing area. As an Antigen Manufacturing Manager, you will be responsible for but not limited to the following:

Ensure safe working environment by ensuring all procedures are followed that ensure safety:

o Ensure all required PPE is worn by personnel and is available. Safety shoes, safety glasses, face shields, gloves, ear plugs, etc.

o Have knowledge of all hazardous materials used in the area and know where MSDS sheets are located and ensure personnel know the hazards.

o Accountable to designate a Fire Wardens, Safety Correspondents, and Hazardous Waste Managers

o Ensure everyone is trained on evacuations plans.

o Participate and ensure personnel participate in the HSE 8+ program

o Maintain housekeeping / organization areas of responsibility.

o Report all Safety incidents and near misses must be reported and communicated using defined formats.

o Investigate fully and implement permanent fixes. Investigations must be documented in Phenix

o Ensure personnel go to health center when required.

o Ensure vaccinations, live area monitoring, and physicals are completed.

o Make sure injuries are checked out at health center.

Accountable for the Quality and cGMP compliance of the area by ensuring cGMP is followed in area of responsibility:

o Communicate areas for cGMP improvement in all areas to your Manager.

o Complete document approval and ensuring the overall document accuracy during approval and review.

o Complete BPR reviews, which include completing section reviews within 24 hours of execution, communicate and remediate entry errors, enter PDW data - logging deviations on the Shop Floor when the issue occurs.

o Complete manager reviews, communicating all deviations to shift for those impacting area, assisting Principle Investigator's in Root Cause Analysis and Preventative Action Implementation - Supporting the technicians on the floor (6-7 hours per day).

o Maintain an understanding of FDA and CQR expectations and requirements.

o Ensure all areas of responsibility are ready for FDA audits; be aware of previous 483 observations and being prepared for FDA audits.

o Ensure technicians fully understand all procedures.

o Completing log book reviews in a timely manner.

o Releasing loads in Service / Buffer

o Ensure that SWI's are used for all operations by operators on the floor.

o Ensuring that all SWI books are compliant - assigning personnel to complete daily temperature checks.

o Leading QDCI (level 1 board) Meetings.

o Ensure updated data on the boards, re-evaluation of metrics to ensure 50 / 50 ratio, complete action items on time, assign action items to appropriate support functions.

o Completing Daily Release.

o Ensure that Area Releases occur when required.

o Ensure cleanings (ACM) are scheduled, performed and compliant

o Ensure that samples are completed according to procedures and schedules

o Ensuring personnel is scheduled and delivers samples on time

Productivity of the area by actively managing activities to ensure optimal process schedule:

o Communicating shift change reports to incoming shift.

o Ensuring equipment availability and process support.

o Coordinating appropriate coverage for area of responsibility.

o Understand and support Department production requirements.

o Effectively scheduling maintenance, PM completion, new equipment introduction

Manage your team:

o Understand company policies and procedures and adherence to P&P

o Ensure personnel have what they need to perform their job.

o Treat people with dignity and respect is a must at all times.

o Complete on the floor coaching, 1 to 1 and development planning, define succession planning for critical roles.

o Personnel reviews completed on timely basis. Documentation of personnel issues, behavior expectations.

o Developmental plans must be created and monitored.

o Proactively manage vacation requests and back fill requirements.

o Ensure training of operators and that tasks are scheduled accordingly, define training and cross training expectations to shift personnel.

o Complete Ceridian and leave of absence processes.

o Proactively approve all requests / needs.

o Ensure accurate Ceridian record keeping.

o Review data for consistency across personnel, absenteeism, etc.

o Resolve issues ASAP.

o Approve personnel time off, callouts.

o Monitor, post changes on personnel schedule and sign - being available to personnel via cell, pagers.

o Communicate with HR.

Provide managerial coverage for employees as required during non-standard working hours, e.g., weekends, and second/third shifts.

BASIC QUALIFICATIONS:

The ability to work a 3rd shift (10 pm-6:30 am) position

BS degree required

5 + years’ experience in:

  • Manufacturing and /or filling of pharmaceutical products.
  • Manufacturing and or development departments.
  • Working with a production department of pharmaceutical company.
  • Working knowledge of cGMP's.
  • Knowledge of continuous improvement techniques and problem solving skills.
  • Working knowledge of SAP

SKILLS:

Excellent verbal and written communication skills

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.

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.

 #GD-SP     

 #LI-SP

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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