Sanofi Group Manager Manufacturing Staff US (2nd shift) in Swiftwater, Pennsylvania
Manager, BSA Manufacturing
The Manager, Biological Services Manufacturing will provide the leadership, direction, and the overall oversight of the B46 Biological Services department on 1st and 2nd shifts at the Swiftwater, PA site. This position is responsible for operational results of BSA operations, including safety, quality, supply, and costs as well as employee engagement and management.
This position is responsible for an operation that runs 5- days per week, and up to 16 hours per day.
In addition, this position is responsible for but not limited to the following:
Providing leadership and direction to the Biological Services Manufacturing team on their assigned shift to meet the established manufacturing plan of the BSA area in their building and may be requested to support other BSA areas and/or other parts of the manufacturing process.
Ensuring the manufacturing facility and equipment within their area of responsibility is properly maintained as well as verifying the continued validated state of all equipment and processes within their assigned area of responsibility.
Providing leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements.
Providing direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained. Ensuring that all associates have what they need to complete their jobs safely.
Special projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area. The development of working relationships and strong communication links through all cross function support areas of the organization.
Providing day-to-day support for the production floor to ensure on time completion of short-term projects.
Providing leadership and establishing departmental objectives to align with site/departmental vision for safety, quality, productivity, cost, continuous improvement, and employee involvement.
Building and maintaining a high performing team, providing effective alignment and communication with functional groups at the site to successfully deliver on all commitments.
Providing direction, evaluate and develop performance of direct reports.
Helping in resolution of problems or introduction of changes in their respective areas
Ensuring a high level of engagement of all direct reports to align and support organization objectives and LEAD Competencies (the “How” we work).
Providing career development and training advice and set short-term and long-term goals.
Providing regular feedback to direct reports on company and departmental operations
Managing headcount and expenses in department to achieve site objectives and meet budget expectations
Chief duty involves providing managerial coverage for employees as required during 2nd shift working hours.
Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, Management Committee, staff meetings), and work unit teams. When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders. Takes a role in implementing new equipment and procedures. Performs all other duties as required by department management. Deviation management, people development, and Quality Assurance of the Aseptic Processing area are required. Background in Aseptic Processing is favorable.
This position will be an off shift position. Applicants must be able to work 2nd Shift hours, weekends, and holidays.
BS degree in Life Sciences, Engineering or equivalent with relevant experience in manufacturing and/or filling of biological products or 3-5 years experience in manufacturing and/or development departments. Must have previous experience in working with a production department of a pharmaceutical company. Working knowledge of cGMP's. Must have knowledge of continuous improvement techniques and problem solving skills. Excellent verbal and written communication skills. Working knowledge of SAP is preferred. Candidate must be able to work overtime and flexible hours, including weekends.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life