Integrated Resources
Job Title: CMC Project Management Manager
Location: Cambridge, MA 02142 (Hybrid)
Duration: 1 Year+ (Contract)
Pay rate:
$60 - $67/hr. on W2
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.
Pay rate:
$60 - $67/hr. on W2
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.