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Job Requirements of CMC Project Management Manager:
-
Employment Type:
Contractor
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Location:
Cambridge, MA (Onsite)
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CMC Project Management Manager
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
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
Qualifications:
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.
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