*3 ON/ 2 days remote FOR NOW and will eventually will go 100% on site**
**M-F -1st shift-- but must be flexible with schedule as per business needs**
**People Mgt Skills**
**Will have report to’s**
**Internal audits and reports**
**Training new specialists**
Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 largescale therapeutic protein manufacturing facility. Operations’ main functions are leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing‘s training program, and identifying and managing continuous improvement initiative.
The supervisor, Manufacturing Specialist uses expert knowledge of compliance and GXP manufacturing processes to lead staff and demonstrate best practices in the management of investigations and improvement initiatives within manufacturing operations.
Practices and promotes safe work habits and adheres to Sanofi’’s safety procedures and guidelines.
Manages cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issue, improve process operations and affect positive change.
Conducts complex document revisions and/or document management including batch production records, manufacturing procedures, and cross functional procedures.
Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
Performs training with staff on the floor, as needed. • Trains new Manufacturing Specialists.
Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology and Manufacturing Technical Services.
Works independently with minimal supervision and direction. • Participates in determining objectives of assignment.
Performs work that consistently requires independent decision making and the exercise of independent judgement and discretion.
Effectively utilize Microsoft office applications. Creates and presents trending and metrics reports.
Provides direction to the Manufacturing Specialist in the absence of the operations manager.
Selects, develops, and motivates qualified staff to effectively carry out department functions and provides 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 aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
Develops work plans, assign tasks and supervise team(s). • Ensures staff has appropriate knowledge of department processes and procedures.
Maintains and reports applicable department or organizational metrics.
Accountable for project completion and achievement of compliance goals.
Represents department Project Team meetings.
Interacts with Project Teams and cross-functional groups as they impact the quality operation.
Addresses and/or escalate CQO compliance problems and issues.
Leadership Qualities Include:
Adhering to all applicable laws and 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 Sanofi 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 judgement in performing our jobs.
Sanofi’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
Sanofi’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 • Sanofi’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 perform to a level of excellence.
High school diploma/GED or Biotech Certification with 7-10 years of experience in cGXP manufacturing environment, or Bachelor’s Degree with 5-8 years of experience.
1 year in a lead or supervisor role.
Demonstrated ability to effectively coach and train employees.
Subject matter expertise in biologics manufacturing.
Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
Minimum of 2 years of experience with deviation or investigation management systems.
Excellent written and oral English language skills.
Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
Ability to influence in a cross-functional environment.
Experience facilitating meetings.
Experience authoring and reviewing standard operating procedures, on-the-job trainings, and other controlled documents.
Familiarity with Deviation Management Systems (i.e. Trackwise).
Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
Special Working Conditions:
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.