CMC Project Manager job vacancy

Vacancy expired!

Job Description:The role of the Chemistry Manufacturing & Control (CMC) Project Manager (PM) is to translate the CMC strategy for a given R&D project into a comprehensive operational plan, including risk assessment. The CMC PM leads the operational execution and oversees the planning, costs and resources in compliance with quality and regulatory requirements. This role will work closely with the CMC Project Lead(s) to develop and align on project plans, manage CMC project teams and timelines, escalate issues, and provide regular updates to stakeholders. The CMC PM is assigned to one or several projects, from preclinical up to submission and approval in the major markets, for Biologics products (mammalian platform and Genomic Medicine Unit).

Basic qualifications are: strong project management skills, good communication skills, experience managing projects in the pharmaceutical or biopharmaceutical arena (experience with Biologics products and gene or cell therapy is a plus), experience leading cross functional project teams in a complex, international and multicultural environment.Years of experience: 3 - 6 Years

Daily Duties:

Defining the plan, steps within projects Daily meetings with team members, progress, planning, plan revisions, addressing escalations, providing reporting and updates to senior management, and preparing and analyzing budgets.
3+ year min of experience in previous Chemistry Manufacturing and Control PM roles.

Must-Have:

Min BS Degree in Sciences (Preferred in Pharm or Biotechnology).
Min 3 Years of experience in a project management-related role.
Experience with Manufacturing, Project Management related to Drug Manufacturing: Specific to: Biological antibodies, gene therapy, cell therapy, and biologics molecules ( experience manufacturing these drugs has specific requirements) .
Previous Pharmaceutical Project Management Experience (risk assessment, project risk assessment, anticipating any issues with supply, suppliers, and manufacturing, – technical project risk assessments).
MS Suite (Excel, Power point, Zoom/Teams, Share point).

Nice to Have:

Experience with manufacturing and regulations specific to: US, EU, Japan, China, general understanding of regulations
MS or PhD
3+ years of experience
PMP Project Management Cert – strong plus!
Experience with: Thinkcell (software)
Excel (Macros).

ID: #49107532
State: Massachusetts Framingham 01701 Framingham USA
City: Framingham
Salary: $65 - $75
Job type: Contract
Showed: 2023-02-09
Deadline: 2023-04-03
Category: Manufacturing