CMC Technical Project Manager (Small Molecules) (contract)

Title:

Project Manager Pay range: $54.00

• 70.

00 per hour

Work Schedule :

1st shift 8:00 am-4:00

Mon-Fri Location:

Cambridge, MA

• Hybrid-Local Candidates only Sanofi's contingent workforce program, FLEXT Direct, is seeking a CMC Technical Project Manager II (Small Molecules) for a 12-month contract, with the possibility of extension.

Description Technical Leader, MSAT CMC Development The MSAT Synthetics team at Sanofi supports CMC Development and Pharmaceutical Technical activities for new R&D compounds, lifecycle management programs (LCM), product extensions, and industrial technical projects. This team plays a critical role in coordinating technical aspects of MSAT and Manufacturing & Supply (M&S) programs, working cross-functionally with Commercial Global Business Units, R&D, Regulatory, and Alliance Management. The team also collaborates closely with internal laboratories and external partners, including CMOs and CROs. The focus is on small molecule development , including drug substance process development and pharmaceutical development for oral dosage forms (e.g., tablets and suspensions). As products approach registration and launch, the team partners with M&S sites, supply chain, and external manufacturing to support execution. Main Accountabilities

CMO / CRO

Management Prepare summaries of proposals, reports, and data from CMOs/CROs for management review Organize technical information to support projects across internal sites and external partners Provide technical support for manufacturing deviations and process improvements Assist with reviewing contracts (CDSs, MSAs, Quality Agreements) and project quotations Technical Management Execute technical strategies for MSAT programs, focused on small molecule development Implement control strategies aligned with regulatory and quality requirements Apply QbD principles, risk assessments, and prior knowledge Conduct risk assessments and define contingency plans Draft technical reports to support lifecycle management Support MSAT Program Directors and CMC Leaders with planning and coordination Review and finalize technical documents (protocols, reports, regulatory content) Project Management Organize meetings and provide project updates to teams and leadership Develop and maintain project timelines and plans Track progress and follow up on action items to ensure timelines are met Coordinate with cross-functional stakeholders (R&D, GBU, M&S teams) Required Skills & Qualifications Education & Experience BS/MS in Chemistry, Pharmacy, or Life Sciences (PhD preferred) Minimum 7+ years of experience in: Technical project management Pharmaceutical development or manufacturing Small molecule drug substance or drug product development Experience leading cross-functional teams International project experience is a plus Quality and/or Regulatory experience is highly desirable Additional Skills Proficiency in MS Office (Word, Excel, PowerPoint, Project) Strong writing and presentation skills Excellent organizational and communication skills CMC Technical Project Manager (Small Molecules) (contract) 4.0 4.0 out of 5 stars 270 Albany Street, Cambridge, MA 02139 Hybrid work $54

• $70 an hour
• Contract Sanofi 5,183 reviews $54
• $70 an hour

• Contract Title:

  Project Manager Pay range: $54.00
• 70.

00 per hour

Work Schedule :

1st shift 8:00 am-4:00

Mon-Fri Location:

Cambridge, MA

• Hybrid-Local Candidates only Sanofi's contingent workforce program, FLEXT Direct, is seeking a CMC Technical Project Manager II (Small Molecules) for a 12-month contract, with the possibility of extension.

Description Technical Leader, MSAT CMC Development The MSAT Synthetics team at Sanofi supports CMC Development and Pharmaceutical Technical activities for new R D compounds, lifecycle management programs (LCM), product extensions, and industrial technical projects. This team plays a critical role in coordinating technical aspects of MSAT and Manufacturing & Supply (M&S) programs, working cross-functionally with Commercial Global Business Units, R D, Regulatory, and Alliance Management. The team also collaborates closely with internal laboratories and external partners, including CMOs and CROs. The focus is on small molecule development , including drug substance process development and pharmaceutical development for oral dosage forms (e.g., tablets and suspensions). As products approach registration and launch, the team partners with M&S sites, supply chain, and external manufacturing to support execution. Main Accountabilities

CMO / CRO

Management Prepare summaries of proposals, reports, and data from CMOs/CROs for management review Organize technical information to support projects across internal sites and external partners Provide technical support for manufacturing deviations and process improvements Assist with reviewing contracts (CDSs, MSAs, Quality Agreements) and project quotations Technical Management Execute technical strategies for MSAT programs, focused on small molecule development Implement control strategies aligned with regulatory and quality requirements Apply QbD principles, risk assessments, and prior knowledge Conduct risk assessments and define contingency plans Draft technical reports to support lifecycle management Support MSAT Program Directors and CMC Leaders with planning and coordination Review and finalize technical documents (protocols, reports, regulatory content) Project Management Organize meetings and provide project updates to teams and leadership Develop and maintain project timelines and plans Track progress and follow up on action items to ensure timelines are met Coordinate with cross-functional stakeholders (R

D, GBU, M&S

teams) Required Skills & Qualifications Education & Experience BS/MS in Chemistry, Pharmacy, or Life Sciences (PhD preferred) Minimum 7+ years of experience in: Technical project management Pharmaceutical development or manufacturing Small molecule drug substance or drug product development Experience leading cross-functional teams International project experience is a plus Quality and/or Regulatory experience is highly desirable Additional Skills Proficiency in MS Office (Word, Excel, PowerPoint, Project) Strong writing and presentation skills Excellent organizational and communication skills