Sanofi
B55 Operations Manager - 1st Shift- Vaccines
Sanofi, Swiftwater, Pennsylvania, United States, 18370
B55 Operations Manager - 1st Shift- Vaccines
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 Manager, B55 Recombinant Manufacturing Facility (RMF) will provide the leadership, direction, and the overall oversight of the B55 RMF department on 2nd 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. Main 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. About You
Required Qualifications
High school diploma with at least a minimum of 5 years of experience that includes: Biotechnology/ Pharmaceutical Manufacturing 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. Preferred Qualifications
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) *For Manufacturing & Supply Only*
Special Working Conditions
Ability to lift to 50 lbs. Ability to stand on average 8 hours per shift. Ability to gown and gain entry to manufacturing areas. Ability to work a twelve-hour rotating shift and every other weekend, including holidays as scheduled. May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need. May also include working in an aseptic processing area. Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to gain experience 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 diligent 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.
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 Manager, B55 Recombinant Manufacturing Facility (RMF) will provide the leadership, direction, and the overall oversight of the B55 RMF department on 2nd 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. Main 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. About You
Required Qualifications
High school diploma with at least a minimum of 5 years of experience that includes: Biotechnology/ Pharmaceutical Manufacturing 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. Preferred Qualifications
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) *For Manufacturing & Supply Only*
Special Working Conditions
Ability to lift to 50 lbs. Ability to stand on average 8 hours per shift. Ability to gown and gain entry to manufacturing areas. Ability to work a twelve-hour rotating shift and every other weekend, including holidays as scheduled. May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need. May also include working in an aseptic processing area. Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to gain experience 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 diligent 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.