**1st shift- 8am-4:30pm**
**Strong technical writing skills, experience with deviations, CAPA's, and change control**
**Leads cross-functional teams including working with Engineering, Validation, QA, QC, Facilities, Metrology, and MSAT**
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) 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.
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.
POSITION OVERVIEW/KEY RESPONSIBILTIES:
The Manufacturing Specialist III uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
- Practices and promotes safe work habits and adheres to Genzyme'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 issues, 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 Science and Technology.
- 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.
- Provides direction to the Manufacturing Specialist in the absence of the operations manager.
- High school diploma/GED or Biotech Certification with 7-10 years of experience, or Bachelor's Degree with 5-8 years of experience.
- Subject matter expertise in biologics manufacturing or a similar complex specialized environment.
- Knowledge and demonstrated understanding of GXP or a similar complex specialized environment and understanding of how it applies to specific responsibilities and manufacturing operations.
- Minimum of 2 years experience with deviation/investigation management systems or a similar technical writing system.
- Excellent written and oral English language skills.
- Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
- Demonstrated ability to lead cross functional teams and facilitate team 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.
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.
- 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.
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.