As part of the Sanofi Biologics Development organization in Framingham, the Drug Substance Manufacturing Biologics (DSMB) is responsible to support manufacturing of cutting-edge biologic drug substance material to support clinical candidate programs. The DSMB group operates in clean-room production suites under cGMP conditions to produce protein drug substance suitable for use in First in Human and later stage clinical trials. The group is responsible for transferring in and implementing the cell culture/production, purification, and formulation bioprocesses for early stage biotherapeutic clinical product candidates. The DSMB group works closely with the Upstream and Downstream Process Development groups to understand each of the products that come through the area. DSMB also interacts closely with the Quality Assurance (QA), Bioprocess Engineering, Validation, and other groups to ensure cGMPs and manufacturing schedules are maintained.
The Manufacturing Specialist I uses knowledge of compliance and GXP manufacturing processes to be a contributor in the upstream production of clinical drug substance materials in a GMP environment. The person also participates in activities related to compliance and validation.
Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines.
Participates in on-the floor participation of upstream activities for executing manufacturing campaigns in a multi-product GMP facility Follows standard operating procedures and/or batch documents to execute activities.
Assists with adapting new and existing equipment to new processes developed for each drug candidate.
Assists with the qualification of equipment along with the SQO-Validation group.
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.
Works under general supervision and direction.
Effectively utilizes Microsoft office applications.
Works weekends and holidays on a rotating basis.
High school diploma/GED or Biotech Certification with a minimum of 3 years of experience in cGXP manufacturing environment or Bachelor’s Degree with a minimum of 1 year of experience.
Experience with both small-scale cell culture and bioreactors.
Knowledge of biologics manufacturing.
Understanding of GXP and how it applies to specific responsibilities.
Excellent written and oral skills.
Must have permanent US work authorization
Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
Experience authoring and reviewing standard operating procedures, batch records and other controlled documents.
Familiarity with Deviation Management Systems (i.e. Phenix).
Experience in troubles shooting investigation, and root cause analysis in a GXP environment.
Excellent written and oral English language skills.
Experience with electronic material management systems.
Experience with Delta V.
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas.
Ability to lift 35 lbs.
Weekend and holiday work required on a rotating basis.
Work with hazardous chemicals.
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.
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