Job Title: Leader for GMP Clinical Injectables External and Internal Manufacturing

Location: Framingham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Leader for GMP Clinical Injectables External/Internal Manufacturing (CIM):

• Within the GMP pilot plant dedicated to Injectables products, Drug Products operations: is a key enabler of the execution of clinical manufacturing for CIM (Clinical Injectables Manufacturing), in collaboration with the FPD (Formulation Process Development) as well as Support teams (CIM and Engineering) with respect of timelines and international Corporate standards for HSE-S and cGMP,

• In charge for technical agreement (cahier des charges),
  
• Ensure the supply of raw materials provided by Sanofi, linking with supply/warehouse functions and track progress of activities,
  
• Draft and/or contribute to the documentation associated to the transfer activities (Procedures, Formulation Transfer Reports, Technical Conditions, ...)
  
• Responsible to address clinical manufacturing request (e-BMO),
  
• Review and approve the Manufacturing Batch Records (MBR) from the CDMOs,
  
• Supervise and Person-In-Plant (PiP) at CDMOs facilities, as required,
  
• Responsible for issuing deviation/events, as required,
  
• End of production's declaration in the Enterprise Resource Planning (ERP) like SAP, and ensure the tracking of the shipment of the clinical lot to warehouse or clinical packaging site,
  
• Responsible for the review of the executed MBR for internal files,
  
• Ensure the reporting on enforced documents for CIM and GQO,
  
• Participate to the CDMOs identification and technical assessment in partnership with Sourcing & External Business Development Opportunities Sanofi R&D.
  

• In charge for technical agreement (cahier des charges),
  
• In charge for manufacturing of clinical lots for Injectables Drug Product forms, with respect of timelines and international Corporate standards for HSE-S and cGMP:
  
• Supervise the preparation, assess process and project risks and approve the Manufacturing Batch Record,
  
• Supervise the manufacturing of clinical parenteral drug products with respect of timelines and international Corporate standards for HSE-S and cGMP,
  
• In charge for HSE risk assessment for operations under her/his responsibility,
  
• Ensure that the manufacturing requests are addressed within timelines and bring answers, maintain the GMP compliance expectations, report KPIs for her/his activity,
  
• Ensure the transfer of information between CIM and the Development and/or Pharmaceutical Eng teams done in due time and in partnership. Review and approve the Formulation Transfer Report (FTR). Active member of the transfer meetings,
  
• Ensure that the manufacturing planning under her/his ownership aligned with RDPM,
  
• Contribute to the GQO and CIM compliance for her/his activities as part of the CIM Quality plan. Participate to the Quality/HSE audits, as well as follow-up actions. Contribute to the quality management via deviations/events, Change Controls and CAPAs,
  
• Propose improvements to enable optimal state-of-the-art activities (processes, equipment investment, Quality Assurance, facilities, maintenance, safety...).
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.