POSITION OVERVIEW / DEPARTMENT DESCRIPTION
As part of the Sanofi Genomic Medicine Unit organization in Framingham, the Cell Therapy Manufacturing Suite (CTMS) is responsible to support manufacturing of cutting-edge biologic drug substance material to support clinical candidate programs. The CTMS group operates in clean-room production suites under cGMP conditions to produce cell therapy products suitable for use in First in Human stage clinical trials. CTMS also interacts closely with the Quality Assurance (QA), Bioprocess Engineering, Validation, and other groups to ensure cGMPs and manufacturing schedules are maintained.
Operations’ main functions are the execution of manufacturing campaigns, 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.
This role is to support clinical manufacturing, as a cell therapy manufacturing specialist in Framingham, MA.
This role is first shift: Sunday to Wednesday 7am-5:30pm OR Wednesday to Saturday 7am-5:30pm.
Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines.
Participates in On-the floor participation in the execution of manufacturing campaigns in a multi-product GMP facility Follows standard operating procedures and/or batch documents to execute activities.
Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.
Assists with document revisions and/or document management including batch production records, and manufacturing procedures.
Authors or revises standard operating procedures to improve compliance and efficiencies.
Assists manufacturing managers and supervisors to develop and maintain training materials on process operations, theory, and compliance.
Performs training with staff on the floor, as needed.
Participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
Works under general supervision and direction.
Participates in determining objectives of assignment.
Performs work that may require independent decision making and the exercise of independent Judgement and discretion.
High school diploma/GED or Biotech Certification with 2-4 years of experience in cGXP manufacturing environment, or Bachelor’s Degree with 0-2 years of experience.
Knowledge of Cell Therapy manufacturing.
Understanding of GXP and how it applies to specific responsibilities.
Excellent written and oral English language skills.
Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering and 0-2 years of experience.
Experience authoring and reviewing standard operating procedures, on-the-job trainings, and other controlled documents.
SPECIAL WORKING CONDITIONS
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
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.
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.