DS Biologics PCU lead

Job Title: DS Biologics PCU lead

• Location: Framingham, MA

About the Job

The APUs are comprised of a subset of the following functional groups: large scale cell culture, downstream purification, CNC and solution prep.  The APU also has multiple support groups that dotted line to the APU Head: engineering, facilities, MSAT, QA, DOT, SMS, HSE and finance. The primary responsibility of the APU is the faithful execution of the current set of instructions, ensuring practice matches procedure, to assure high product quality and compliance with current cGMPs and Sanofi 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 Manufacturing PCU Lead sets operating plans and priorities for production that are aligned with our delivery objectives. They are responsible for the safe compliant manufacturing of Fabrazyme, Cerezyme, Nexviazyme and Thyrogen to meet our patient supply needs and our business commitments. 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 various Manufacturing and support groups.

About Sanofi:

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.

Main 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 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.

• Ensure that all Manufacturing activities are performed in compliance with cGMPs.

• Ensure that Manufacturing staff are sufficiently trained to perform their job responsibilities and that each has an approved job description.

• Oversee either directly or indirectly, Manufacturing investigations, CAPA process variances and deviations. Ensure that all Manufacturing owned change control, CAPA, and deviations are completed by the due date.

• Ensure control over process, equipment and facility changes.

• Support all internal and external cGMP compliance audits.

• Establish and maintain effective partnering relationships with Quality staff.

• Ensure Manufacturing work practices are in accordance with the Genzyme-Sanofi Safety Programs.

• Establish departmental and individual goals and objectives in alignment with site goals and priorities.

• Identify the required resources and expertise, implement the appropriateteam/departmental structures and establish the required processes and communications to enable department (s) to effectively deliver on all commitments.

• Develop strategies that ensure achievement of manufacturing objectives that areconsistent with the site’s strategic direction.

• Develop and successfully manage to a production plan which supports a reliable product supply while upgrading the facilities and equipment and establishing capable, compliant manufacturing processes for area of responsibility.

• Active member of the APU Leadership team, Leader of the PCU Team.

• Define and hire necessary resources to meet manufacturing objectives. Ensure effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognition practices in area of responsibility.

• Strengthen overall leadership and organizational capabilities in area of responsibility. Build and sustain a high-performance team and ensure strong alignment and coordination with other functional groups at the site.

• Ensure team members achieve their potential, and the teams meet their goals. Develop succession plans as applicable for department.

• Provide technical leadership to the manufacturing team in area of responsibility and keep current on trends and new technologies and developments in area of responsibility.

• Manage departmental headcount and spending to budget.

• Participate in the development, revision and accuracy of the short- and long-range production plans.

• Support and/or undertake long and short-term planning and supervision of projects that require cross-functional interaction, alignment and coordination.

• Lead the Manufacturing team in area of responsibility to excellent performance through a structured manufacturing system with the use of Operational Excellence tools: e.g. LEAN-Kaizen; MDI.

• Manage employees, either directly or indirectly, who are involved in scheduling.

• Implementation, execution and/or maintenance of manufacturing process and operations.

• Anticipate, identify and communicate risks in area of responsibility and across the site; participate in the creation of, support, and/or drive plans to manage and mitigate risks to the operations.

• Work with peers and counterparts across functions and sites to drive manufacturing excellence, share best practices and lessons learned to create industry-leading manufacturing of medicines and devices for patients.

• Continually track and maintain performance metrics. Routinely issue reports and engage staff and colleagues to drive and continuously improve performance.

About You

Basic Qualifications

• Bachelor’s degree with at least 12 of technical/operational leadership experience.

• OR master’s degree with technical/operational leadership experience.

• 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.

• Excellent people leadership and change leadership skills.

• 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.

• 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.

• Ability to set ambitious and realistic targets, drive execution and build culture of continuous improvement and accountability.

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.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.