Job Description:
Job Title: MFG PCU Lead Upstream
Location: Framingham, MA
Job Title: MFG PCU Lead Upstream
Grade: L3-2
Hiring Manager: Joseph Panella
Location: Framingham, MA
About the Job
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.
Your job, as PCU Lead Upstream within our Upstream Manufacturing group, will be to have primary responsibility of the Manufacturing organization and enable the faithful execution of the current set of instructions, ensuring practice matches procedure, to assure high product quality and compliance with current cGMPs and Genzyme Quality standards, to always operate in a safe and environmentally sound manner, to develop and adhere to a production plan which supports a robust product supply, to continually improve processes, and to manage the budget.
The Upstream Manufacturing organization consists of the following functional groups: Large Scale Cell Culture, Small Scale Cell Culture.
This key leadership role serves to ensure manufacturing activities are operated in a safe and GMP compliant manner and managed to meet our supply and regulatory requirements.
This position will report to the APU Head.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities
- The PCU Lead sets operating plans and priorities for production that are aligned with our delivery objectives.
- The responsible person ensures appropriate resources are in place to fulfill near term goals and commitments while building towards sustainable manufacturing excellence.
- It is the responsibility of this position to oversee, direct and support the Manufacturing group according to Sanofi policies and to achieve business objectives that will have a major impact on the success of the Corporation.
- This individual is responsible for ensuring strong coordination and alignment between Manufacturing and support groups.
Specific cGMP Responsibilities
Provide direct oversight for the Manufacturing operation with the following specific responsibilities:
- Ensure that products are produced and stored according to the current set of instructions.
- Ensure practice matches procedure.
- -Ensure appropriate maintenance and a state of qualification is maintained for equipment and facilities in area of responsibility.
- Ensure that facilities and equipment in area of responsibility are maintained in a state of microbiological control.
- Ensure that facilities and equipment in area of responsibility are in a state of audit readiness at all times.
- Ensure all personnel, including contractors, consultants and temporary employees who work in Manufacturing and directly or indirectly support a cGMP activity, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
- Support all internal and external cGMP compliance audits.
- Establish and maintain effective partnering relationships with Quality staff.
About You
Required Qualifications
- Bachelor's or master's degree and at least 15 years of progressive technical/operational leadership experience or equivalent required.
- In-depth knowledge of biopharmaceutical, pharmaceutical, and/or device cGMP manufacturing is critical.
- Demonstrated ability to manage complex functional areas and achieve significant business results.
- Track record in successfully managing mid to large, complex manufacturing operations in the later stages of plant life cycle.
- Demonstrated ability to develop self; build high performance teams and develop others.
- Excellent communication skills and ability to influence and build relationships across the broadest constituencies both internal and external to the site.
Preferred Qualifications
- Track record in successfully managing manufacturing operations during multiple stages in the life cycle of a manufacturing plant (start-up, growth, steady state and declining phases).
- Solid understanding of Health, Safety, Environmental and legal requirements for operations.
- Excellent problem solver and able to generate innovative solutions to a broad range of issues.
- Excellent people leadership and change leadership skills.
- Ability to set ambitious and realistic targets, drive execution and build culture of continuous improvement and accountability.
Special Working Conditions
- Ability to gown and gain entry to manufacturing areas.
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent 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 good 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.
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