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At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Summary:

The Manufacturing department is dedicated to the formulation, filling, inspection and packaging of medical devices and drug products. The Manufacturing group aseptically fills syringes and vials to satisfy the site's monthly volume plan. These vials and syringes are inspected and packaged for domestic and international customers. The Manufacturing department follows cGMP and applicable regulations to provide quality products to customers.

• Manage the Component Preparation and HA production area which includes two steam sterilizers, parts washers, CIP/SIP of the production vessels, bulk intermediate solution preparations and the area personnel to work effectively as a team to support manufacturing operations to deliver high quality products within the budget.

• Ensure staff is properly assigned to achieve monthly volume targets.

• Manage staff training and verify staff is trained and fully qualified to perform their duties.

• Ensure required Athena system transactions are completed so that components are available for processing when needed and orders are closed in a timely manner.

• Work with Facilities Department to resolve equipment performance issues.

• Perform or ensure completion of monthly safety walk-th roughs to ensure no hazardous conditions exist.

• Actively contribute to the improvement of policy, practices, and procedures.

• Author and revise Standard Operating Procedures (SOPs), Master Batch Records (MBRs) and specification for the area of responsibility as needed.

• Author or act as subject matter expert for non-conformance reports that occur in the area of responsibility.

• Manage corrective and preventive actions and work with Quality Assurance Department to ensure timely completion of investigations and CAPA implementations.

• Act as change owner or subject matter expert for change control requests as needed.

• Support internal and external audits as required.

• Foster a culture of teamwork, compliance, quality safety, and productivity

• Take prompt action to remediate employee performance issues while recognizing and rewarding positive results and performance.

• Track and monitor metrics related to individual and departmental goals and react to those metrics to ensure the achievement of said goals.

• Help establish departmental goals and expectations of direct reports.

• Ensure that all regularly scheduling, vacations, and other time off work for Manufacturing team members are properly documented for payroll and attendance records.

• Ensure compliance with the applicable corporate guidance, standards, and policies.

• Willing to work off shifts and weekends as needed to support activities.

• Utilizing quality systems to measure, analyze, and improve team performance

• Participating in/leading scheduling, project, and staff meetings, providing updates of department activities and project statuses.

• Designing Department Training Plan, managing execution and monitoring training of direct reports.

• Ensuring Inspection Readiness of assigned manufacturing areas.

• Participating in inspections conducted by external regulators and ensuring the success of audits for the department.

• Responsible for on-time completion of investigations, CAPAs for all deviations, and CCRs.

• Participating in formal FMEAs and RAs.

• Review and approve Quality Reports, validation protocols, and validation reports.

• Complying with requirements from Sanofi Safety Program including Health and Safety regulations and OSHA requirements.

• Provide technical support and guidance as it impacts production processes and resolution of exceptions and investigations.

• Overseeing departmental projects and ensuring that the appropriate controls, approvals, and validation requirements are implemented.

• Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner

• Identifying and following up/leading opportunities to improve manufacturing processes and practices.

• Ensuring all manufacturing management tools/systems and documentation (eg. SOPs, OJTs) are accurate.

• Partnering with Manufacturing Engineering/Product Manager to troubleshoot and drive resolution of process issues and continuously proactively driving projects to improve manufacturing processes.

• Ensuring timely issue escalation to manufacturing senior management and cross-functional support teams.

• Ensures adherence to production schedules, while holding Leads and teams responsible for compliance to all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet production schedules. Ensuring adherence to PM and validation schedules.

• Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports.

• Ability to gown for entry to Aseptic manufacturing areas.

HSE

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.

• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.

• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

• All area leaders are to complete required monthly Managerial Safety Visits (MSV).

Basic Requirements:

• 7-10 years' experience in a cGMP Aseptic manufacturing environment.

• At least 5-7 years leading direct reports

• Bachelor's Degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry) or Engineering

• Strong understanding of Quality systems

• Training, coaching, and leadership experience.

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.

Learn more about Sanofi M&S: https://www.youtube.com/watch?v=_xz_sSanXhc

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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Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !