Sanofi Group Manufacturing Specialist II in Framingham, Massachusetts
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 large-scale 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 initiatives.
The Manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
• Practices safe work habits and adheres to Sanofi safety procedures and guidelines.
• Participates on cross functional teams to drive 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 issues, improve process operations and affect positive change.
• Conducts document revisions and/or document management including batch production records, and manufacturing procedures.
• Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations,theory, and compliance.
• Supports training of new Manufacturing Specialists.
• Organizes and participates on 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 judgment and discretion.
• Effectively utilizes Microsoft office applications.
• Creates and presents trending and metrics reports.
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:
• 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 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.
• High school diploma/GED or Biotech Certification with 5-7 years of experience in cGXP manufacturing environment, or Bachelor's Degree with 3-5 years of experience.
• Demonstrated knowledge I understanding of biologics manufacturing.
• Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
• 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.
• Minimum of 2 years experience with deviation or investigation management systems.
Special working conditions:
Ability to gown and gain entry to manufacturing areas.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life