Senior Project Manager

Title: Technical Leader, MSAT CMC Development

Location: Cambridge, MA (Hybrid )

Duration: 12 Months+ Possible Extension

Manager Notes:

• Hybrid 3 days required onsite
• Position fully onsite
• Day to Day: Managing multiple projects, writing reports, reviewing reports
• Validating data on the reports
• Assisting with drafting regulatory documents
• CMC sections of Modules 3 supporting regulatory applications
• Work with 3rd parties/ manufacturing.

Top required skills:

• Combined min 7 years of related experience; with required BS/ MS degree, PHD preferred
• Must have recent experience with small molecules and pharmaceutical development/ synthesis
• Small molecule vs. Biological/ vaccines, not applicable.
• Chemistry and Pharmaceutical Development
• Previous experience as Senior Research Associate Director, Process Development Lead CMC/ Associate Research Scientist

Nice to have Skills:

• Veeva experience is a plus

Description:

• The MSAT Synthetics team at Client is dedicated to supporting CMC Development and Pharmaceutical Technical activities for new R&D compounds, Life Cycle Management Programs (LCM), product territory extensions, and industrial technical projects.
• Our team plays a critical role in coordinating multiple technical aspects of MSAT and Manufacturing and Supply (M&S) Programs through organization and alignment with other Client group divisions including Commercial Global Business Units, R&D, Regulatory, and Alliance Management.
• We collaborate closely with various internal Client support laboratories and external contract organization facilities. Our focus includes development activities supporting the small molecule portfolio, encompassing drug substance process development and pharmaceutical development for oral dosage forms such as tablets and suspensions.
• As products approach the registration and launch stage, we work closely with M&S Sites, Supply Chain, CMOs (through External Manufacturing), and Alliance Partners to outline comprehensive plans and activities.

2.2 Main Accountabilities

A. CMO/CRO Management

• Prepare summaries of proposals, reports and data from CMOs/CROs for projects and present to management for review
• Obtain and organize necessary technical information to support projects at internal Client sites or CMO/CROs
• Provide technical support to manufacturing sites for significant deviations and drive process and product life cycle management improvements for process robustness and yields
• Assist with reviewing contracts (CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, industrial technical projects and internal industrial development programs

B. Technical Management

• Execute 2nd generation program technical strategies to the MSAT Technical Product Team, focused on synthetic process development and/or pharmaceutical development of oral dosage forms for small molecules
• Implement product control strategies in compliance with overall regulatory/quality requirements
• Select appropriate QbD strategies, process parameter risk assessments, and application of prior knowledge
• Conduct risk assessments for project activities and outline contingency plans
• Draft product- and process-specific technical reports to support life-cycle management activities
• Support MSAT Program Directors and CMC Leaders with planning, coordinating and following activities for the various types of projects
• Assist with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content

C. Project Management

• Organize meetings and prepare project updates for project teams and M&S management
• Create and maintain detailed timelines and project plans with input from Program Directors / CMC Leaders
• Organize meetings with project teams for status updates and action items follow-up to ensure adherence to timelines
• Organize meetings with sponsors (R&D, GBU, M&S Teams) to communicate project updates
• Create and maintain detailed project plans with gating / milestones

Section 4: Required Skills & Qualifications

4.1 Education & Experience

• BS/MS in Chemistry or PhD (preferred), Pharmacy or Life Sciences required;
• Minimum 7 years of experience in technical project management, pharmaceutical development, technical operations and/or manufacturing of small molecules and/or of drug product dosage forms for small molecules
• Demonstrated experience as a technical project manager with ability to facilitate multi-disciplinary teams
• Experience with international project teams is a plus
• Quality and/or Regulatory background highly desirable

4.2 Other Skills

• Proficiency in MS Office (Word, Excel, PowerPoint, Project)
• Solid writing and presentation skills
• Excellent organizational and communication skills

• Job Schedule