CMC Synthetics Clinical Manufacturing Leader

About the role

The Projects and External Technologies team, part of the CMC Synthetics organization within Sanofi R&D, is responsible for the delivery of clinical drug substance and drug product batches in full compliance with project requirements, Sanofi policies and GMP regulation, leveraging internal and external manufacturing capabilities. We are looking for a highly motivated and collaborative individual with expertise in drug substance or drug product manufacturing to join our team.

Responsibilities

• Act as a CMC core team member accountable for sourcing of clinical DS and DP supplies.
• Define project needs in terms of clinical manufacturing.
• Gather from project team short, mid and long-term forecast of activities.
• Establish, update and communicate sourcing plans.
• Lead sourcing strategy: internal vs external, as well as CDMO selection.
• Closely follow manufacturing operations done internally or externally from kick-off to activity closure.
• Cookordination planning alignment between internal and external manufacturing activities.
• In case of reinternalization: co-lead process transfer from CDMO to internal pilots (with Process Chemistry and Process Eng./DP Design for DS/DP).
• Ensure appropriate follow up of project progress (either externally or internally) and key events.
• Actively challenge and provide technical / scientific input.
• Prepare Requests For Proposal.
• Participate in regular meetings with external partners.
• Review and approve all GMP documents (Technical Conditions, Master Batch Record).
• Ensure tracking of quality events (Change controls, Deviations) and appropriate integration in Sanofi quality system.
• Outsourcing management local point of contact.
• Communicate on outsourcing processes.
• Support vendor management for US based CDMOs.

Requirements

• Pharm. D. or PhD in Pharmaceutics, Chemistry, Chemical Engineering or related.
• Minimum 5 years of strong and proven industry expertise in Drug Substance and/or Drug Product manufacturing.
• Trained and experienced in working in a GMP environment.
• High ability to work transversally in complex international, multi-cultural and changing environment.
• Experience in working with a CDMO or managing outsourced activities and in close collaboration with Sanofi manufacturing pilots.

Qualifications

• Good communication skills.
• Strong teamwork and ability to collaborate across functions.
• Ability to make proposals and prioritize in a complex and changing environment to support efficiently a diversified and very dynamic portfolio.

Benefits

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. #GD-SA #vhd

Pay

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.