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Project Manager Senior - Biopharma CMC - Remote (JP9824)

Cambridge, MA · Biotech/Pharmaceutical
Job Title:   Project Manager Senior - Biopharma CMC - Remote (JP9824)
Location: Cambridge, MA. 02138 (Remote work)
Employment Type:  Contract
Business Unit: Business Analysis
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 2/16/2022
Notes: Must have any of the following educational backgrounds Biology/Biochemistry/Biomedical/Chemistry. NO Information Technologies, Function admin, or facility project management.

3 Key Consulting is hiring a Project Manager Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
The Sr. Project Manager will be responsible for:
  • Supporting drug substance, drug product, and combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives.
  • Integrating and understanding Process Development activities by developing and maintaining product project timeline across the commercialization lifecycle within client’s commercial portfolio.
  • Leading 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.
  • Driving negotiation, decision making, and conflict resolution among team/functional members to accomplish project and business goals.
  • Partnering with key Product Delivery Team stakeholders, understanding the Clinical Development Plan and strategy to enable alignment with clinical and commercial targets.
  • Drafting timeline scenarios to enable/adjust project execution across multiple development paradigms to inform portfolio decisions.
  • Ensuring teams’ active, aligned communication in functional and cross-functional management reviews and governance meetings.
  • Driving decision making and communication
  • Establishing and managing collaboration and team sites. Track delivery and create repositories for all PD deliverables
  • Project reporting including appropriate risk analysis
  • Partnering with Business Analytics and functional partners as needed to provide data
  • Facilitating and incorporating lessons learned, standard methodologies, etc.
  • Supporting Business Process improvements, including alignment with the Commercialization Office

Must recognize:
  • Drug Development Late stage and life cycle management
  • Commercial process development
  • Process characterization
  • Tech transfer
  • Combination product design/development
  • Drug delivery process
  • Design Controls

Why is the Position Open?
Supplement additional workload on team.

Top Must Have Skills:
  • Certified Project Manager
  • Expert in Microsoft Project
  • Communication skills
  • Biotech experience
  • Quality experience
  • Smartsheet experience a plus

Day to Day Responsibilities:
  • 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
  • Develop and use project plans and schedules to measure and report progress.
  • Participate in cross-functional project team(s) from multiple client sites, and external partners, to develop innovative drug and combination drug/device products.
  • Responsible for developing and maintaining project schedules for client life-cycle management projects and providing general project management support to product delivery teams.
  • Partner with process development technical leads and other cross functional partners to identify key deliverables and ensure cross functional alignment and accountability.
  • Assist by driving decision making for assigned projects in alignment with client’s decision model (DAI).

Basic Qualifications:
  • Master’s degree and 3 years of Project Management experience OR Bachelor’s degree and 5 years of Project Management experience OR Associate’s degree and 10 years of Project Management experience OR High school diploma / GED and 12 years of Project Management experience

Preferred Qualifications:
  • At least 2-years of experience as a project manager
  • 10-years of experience in the Pharmaceutical, Biotechnology or Biomedical related field, direct CMC experience is highly desirable
  • Microsoft Project (or equivalent project management software) and Microsoft Office skills
  • Facilitation and soft skills to work with cross functional teams
  • Critical thinking and problem-solving skills
  • Experience in the Pharmaceutical, Biotechnology or other Healthcare related field
  • Master’s degree with 4 or more years of projects management experience, OR Bachelor’s degree with 6 or more years of project management experience.
  • Ability to cultivate collaboration and work effectively on cross-functional teams
  • Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization
  • Critical thinking and problem-solving skills
  • Apply standard Project Management tools, and practices; experience with Excel and SharePoint highly desirable
  • Self-driven
  • Able to work independently

Employee Value Proposition:
The personal in this role will be working on process improvement.

Red Flags:
NO experience in drug development (CMC).

Interview process:
Video Skype Panel Interview.


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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