East Swiftwater, Pennsylvania; Swiftwater, Pennsylvania
Location: Swiftwater, PA
THIS IS A THIRD SHIFT POSITION (10:00 PM TO 6:30 AM)
The B56 Manufacturing Manager provides leadership and direction to the B56 operational staff.
This includes the following:
Provides feedback on their performance as needed as well as on monthly one on one meeting.
Responsible to ensure staff development needs and provide support and accountability for achieving results, and KPI’s in a GMP environment as well as for professional development.
Provides leadership and direction to ensure deviation investigations are initiated, reviewed and closed on time. Provide support and direction to ensure CAPA’s, Change Controls, internal audits items, and any other regulatory commitments are met on time. Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality Requirements.
Provides leadership and direction on the B56 shop floor to maintain the area is operating at the highest safety and quality standards. Complete HSE investigations and provide support for HSE CAPA’s. Works to ensure that all technicians have what they need to complete their job compliant and in a safe manner
Provides leadership and direction to quality documentation in B56 shop floor. This includes but not limited to reviewing and approving equipment printouts, logbooks, and temperature charts. Also involves reviewing Batch Production Records (BPR’s) in a timely manner in order to hit production targets. Additionally, review and approve quality documents and procedures.
Provides leadership and direction in regard to equipment, process improvement, and facility requirements from support systems. Assist B56 production employees through development of working relationships and strong communication links through all levels of the organization. Provides day-to-day support for the production floor to support completion of short-term projects needed to support the business side of production including production scheduling
Provides leadership and support to ensure there are departmental objectives and metrics to align with the vision of the site in the areas of safety, quality, cost, production delivery, continuous improvement, and employee development. Ensure appropriate staffing levels and maintain personnel scheduling. Ensure training goals and KPIs are met to provide functional production support.
Responsible for timely supply of BSA, polysaccharide and conjugated material from B56 for further downstream production of the Menactra and MenQuadfi vaccine
Responsible for providing coaching, development, and leadership to a team of approximately 5 technicians. There is also a shared leadership per shift with a team of >20 and across different departments within the same building.
Key indicators on which the job holder will be evaluated (WHAT in 9 box):
Leading a shift that works in a 24 hour, 7 day per week operations to meet a demanding production schedule while exceeding the increasing requirements for quality and safety requires a high degree of flexibility and creativity.
Supervision of all bacterial technicians on a given shift. Decisions are made on highly complex matters involving technician feedback was well as proper communication to the Deputy Director as well the quality team and other support groups. Decision typically affects more than one major segment of the Company and can only be reversed or modified at a high cost to the Company.
BASIC QUALIFICATIONS (THIS IS A THIRD SHIFT POSITION (10:00 PM TO 6:30 AM) )
High School OR G.E.D. Required AND 10 years’ experience experience in a manufacturing environment.
Thorough knowledge of cGMPs and regulatory requirements are required.
Leadership and people management skills are required.
Bachelors Degree in Life Sciences, Engineering or Management is desirable.
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.
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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