Leader for GMP Clinical Injectables External and Internal Manufacturing

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

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,

• Within the Drug Products injectables manufacturing operations executed on outsourced (CDMOs) or internal sites: ensure the implementation, coordination and tracking of activities in collaboration with FPD with respect of timelines,

• Bring her/his process expertise in an operational role to support process development at CDMOs or on CIM internal filling lines, for scale-up and technology transfer in collaboration with FPD and Pharmaceutical Engineering SMEs for the products, as required for development/technical/stability runs from laboratory up to the pilot or industrial clinical scale, with respect of timelines and international Corporate standards for HSE-S and cGMP,

• Bring her/his process expertise for the sterile equipment train of the GMP pilots (CIM internal/external CDMOs).

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

Manufacturing Sterile Injectable Operations sub-contracted

• 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.

Manufacturing and operational excellence

• 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…).

About You

Requirements:

BS degree in Life Sciences field, or equivalent, plus 5+ yrs. of relevant experience OR MS degree in Life Sciences field with 3 plus years of relevant experience.

Why Choose Us?

• 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.

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.

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