CMC Project Manager

Job Title: CMC Project Management Manager

Job Description

Manager, CMC Project Management (Contract)

Cambridge, Hybrid

Summary of Key Responsibilities

·        Management of project plans and timelines for the completion of all ongoing CMC activities (Chemistry, Manufacturing, and Controls) required to support Life Cycle Management of Commercial programs

·        Work together with Commercial CMC leads and expertise areas (Regulatory Affairs, Manufacturing, Manufacturing Operations Support, Process Sciences, Supply Chain and Quality) to establish/update project plans including risk mitigations for the Technical Operations and Quality Organization

·        Support Early-Stage programs by updating ES/Development CMC templates in Smart Sheet to stay current with the changes in the process

·        Collaborate with CMC PMs and leads on improvement of project plans including resources and risk mitigations for the Technical Operations

·        Prepare and present project improvements to CMC PM team

Qualifications

·        Bachelor’s degree is required. Degree in life sciences/engineering is strongly preferred

·        3-5 years of development and/or project management experience within the biopharmaceutical or pharmaceutical industry

·        Experience with different stages of CMC development (Early stage (Ph I/II clinical trials) and Late/Commercial) preferred

·        Experience working with MS Office Suite (Excel, Word, PowerPoint) and Smart Sheet

·        Highly motivated and flexible, with excellent organizational, time and project management skills

·        Strong interpersonal and communication skills

·        Ability to work independently and as part of a multi-disciplinary team