B55 Operations Manager - 2nd Shift

Sanofi•Swiftwater, PA

5d•Onsite

About The Position

The Manager, B55 Recombinant Manufacturing Facility (RMF) will provide the leadership, direction, and the overall oversight of the B55 RMF department on 1st shift at the Swiftwater, PA site. This position is responsible for operational and project results of B55 operations, including safety, quality, supply, and costs as well as employee engagement and management. Sanofi is seeking a highly skilled and experienced Manager to oversee our manufacturing processes. The ideal candidate will have outstanding organizational and leadership skills, a firm grasp of manufacturing processes and standards, and the ability to ensure that our manufacturing processes deliver products of maximum quality. 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. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

High school diploma with a minimum of 5 years of experience that includes:
Biotechnology, Pharmaceutical Manufacturing or cGMP experience
Working within a quality or production department of a Biotechnology/ Pharmaceutical company
cGMP experience
Excellent communication and interpersonal Skills
The ability to work on cross functional project teams.
Demonstrated ability to meet/exceed timelines/deliverables.
Continuous improvement techniques and problem solving/analytical skills.
Ability to negotiate/Influence.
Organized and detail oriented.

Nice To Haves

Experience with the management of direct reports.
Experience in Viral manufacturing and/or Bacterial Manufacturing
Leadership, people development, driving the right culture and mindset (10+ people report to this position, helping to drive Tier 1 Site Projects)
Operational Excellence – Adaptation and driving the use of SMS tools, continuous improvement, cost savings, inventory control (SAP / S4), Digital and AI – Openness
Quality and Compliance – regulatory audit experience, driving compliance performance (deviation elimination, implementation of CAPAs to improve or error proof).
Root cause analysis and Change Management.
Experience in driving an initiative or project to completion as an owner
Able to work with multiple stakeholder groups, adaptable (ability to respond to changes in initiative / timeline / priority)

Responsibilities

Manage Multiple priorities independently or as part of a team to meet key deadlines.
Communicate issues and progress across all levels of the organization.
Resolve QA shop floor observations promptly to maintain product quality.
Perform monthly HSE audits, complete HSE investigations, and provide support for HSE Corrective and Preventive Actions (CAPAs).
Perform GEMBA Walks to ensure strict adherent to quality and compliance in our facilities.
Support Deviation closures to ensure compliance and continuous improvement.
Support CAPAs, Change Controls, internal audits and any other regulatory commitments.
Execute Batch Record Sections and Final Review in a timely manner in order to hit production targets.
Manage +QDCI L1 boards to meet company KPIs and drive change.
Establish performance expectations and evaluate direct reports.
Manage employee development goals to foster growth and skill.
Support a culture of teamwork.
Drive efficiently in communication between employees through shift change huddles.
Manage personnel attendance using Labor Utilization Role-Based Schedule Tool, ADP, Workday.
Actively involved in onboarding new hires to ensure smooth integration.
Monitor Metasys/Lab watch applications to ensure GMP status of the production floor.
Serve as an escalation point and make decisions to resolve issues promptly.
Responsible for project work on the shop floor, provide assistance and recommendations regarding processes or equipment.
All other duties as assigned.