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CMC Operations Senior Project Manager

Cambridge, MA
Top 3 Must Have Skill Sets:    

Must have Biology/Biochemistry/Biomedical/Chemistry background. NO Information Technologies, Function admin, or facility project management.
- late stage and life cycle management
-Commercial process development
-Process characterization
-Tech transfer


**Must have Biology/Biochemistry/Biomedical/Chemistry background. NO Information Technologies, Function admin, or facility project management. Please do not submit unless they have that specific background.**


Must recognize:
? late stage and life cycle management
?Commercial process development
?Process characterization
?Tech transfer

Key words on resumes: drug substance, drug product, drug development, cross functional support, combination product, late stage (Commercial Process Development), LCM, CMC operations, process development. Bold = MUST HAVE TWO OR MORE OF BOLDED KEY WORDS
Preferred qualifications
? At least 2 years of experience as a project manager
? years of experience in the Pharmaceutical, Biotechnology or Biomedical related field, direct CMC experience is highly desirable
? Microsoft project and office skills
? Soft skills to work of cross functional teams
? Critical thinking and problem-solving skills
The Sr Project Manager will be responsible for integrating and understanding Process Development activities by developing and maintaining product project timeline across the commercialization lifecycle within commercial portfolio.

The Sr. PM will lead cross-functional teams within Process Development across all modalities and across all commercialization stages as needed. They will partner with technical leads to identify key deliverables, ensure cross functional alignment, and execute plans. They are expected to proactively manage plans to meet deliverables with their teams.

Partnering with key Product Delivery Team stakeholders, the Sr. PM will need to understand the Clinical Development Plan and strategy to enable alignment with clinical and commercial targets

The Sr. PM will draft timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions

Ensure teams active, aligned communication in functional and cross-functional management reviews and governance meetings

Assist PD in driving decision making and communication

Establish and manage collaboration and team sites. Track delivery and create repositories for all PD deliverables

Project reporting including appropriate risk analysis

Partner with Business Analytics and functional partners as needed to provide data

Facilitate and incorporate lessons learned, standard methodologies, etc.

Support Business Process improvements, including alignment with the Commercialization Office

"This posting is for Contingent Worker, not an FTE"

 

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