Sanofi Group Sr. Manufacturing Manager in Framingham, Massachusetts
Selects, develops and motivates qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Provides leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
Coaches and mentors staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.
Develops work plans, assign tasks, and supervised team (s).
Ensures that staff has appropriate knowledge of department processes and procedures.
- Provides input into the department budget.
Maintains and reports applicable department or organizational metrics.
Accountable for project completions and achievement of compliance goals.
Represents department in Project Team meetings.
Interacts with Project Teams and cross-functional groups as they impact the operation.
Addresses and/or escalates site compliance problems and issues.
Plans and coordinates operations to meet production schedules, product standards, and operational costs.
Prepares production, personnel and financial reports to achieve production goals. Establishes operating policies and procedures to achieve production schedules, product standards, and operational costs.
Responsible for the coordination of multiple functions within a facility.
Manages the commercial scale cGMP, clean room manufacturing of Biosurgery products.
Production scheduling, meet demands of internal customers, and work with a cross functional team to meet product release cycle time.
Participates in the short and long range planning and budgeting process.
Ensures timely resolution of deviations related to production batches, and the on time implementation of corrective and preventative actions (CAPA).
Routinely work within a team including Manufacturing, Engineering, Stability, Validation, QA, QC, Materials and Regulatory to implement process, documentation, and equipment improvements.
Motivates and drives direct reports and support groups to meet key performance indicators (KPI) for site goals, including on time training, first pass yield, deviation per FTE, production yield targets, CAPA on time completion and cost of goods (COGM).
Manages for Daily Improvement-Engage the staff in continuous improvement efforts by managing effective daily MDI meetings.
Manages change control process to implement new equipment and process improvements.
Ensures the implementation and maintenance of Quality systems and policies.
Serves as a lead Manufacturing contact during audit and general support during audits by external regulatory agencies.
Oversees the CAPA program for the department, including review and approval of CAPA plans and implementations.
Reviews all related deviations and change controls.
Manages product risk profiles as they are impacted through change control.
Provides oversight and coordination for other ancillary compliance activities and programs such as facility shutdowns, sanitization, pest controls and walk-throughs.
Compiles and reports on internal compliance metrics during Management Review and other forums.
Ensures that documentation and operations meet established requirements of cGMPs, internal SOPs and corporate standards.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Genzyme’s leaders motivate, inspire, build and retain highly effective manufacturing teams while managing for high performance and developing others.
They are versatile learners and courageous decision makers.
Leading the Business:
- Genzyme’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers:
- Genzyme’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.
Bachelor’s degree required
8-10 years relevant manufacturing experience in Biologics, Medical Devices or Pharmaceuticals.
2+ years in a supervisory/ management capacity in a cGMP/clean room environment.
Computer skills including Word, Excel and PowerPoint.
Ability to work well with and/or lead a team and to work independently.
Strong verbal and written communication skills.
Six Sigma, Lean Methodologies, Continuous Improvement.
Good mechanical aptitude.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.