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Senior Project Manager-Drug Development- Remote (JP9661)

Cambridge, Massachusetts · Biotech/Pharmaceutical
Job Title: Senior Project Manager-Drug Development- Remote (JP9661)
Location: Cambridge, Massachusetts 02138
Employment Type: Contract
Business Unit: Business Analysis
Duration: 10 months with likely extensions
Job posting date: 1/11/2022
Note: Remote  

3 Key Consulting is hiring a Senior Project Manager-Drug Development for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • Must have any of these educational backgrounds:  Biology/Biochemistry/Biomedical/Chemistry.
  • NO Information Technologies, Function admin, or facility project management.
  • 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
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
  • 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.
  • At least 2-years of experience as a project manager
  • 10 years of experience in the Pharmaceutical, Biotechnology or Biomedical/healthcare related field, direct CMC experience is highly desirable
  • 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, Critical thinking and problem-solving skills. Independent worker.
  • Microsoft Project (or equivalent project management software) and Microsoft Office skills
  • Facilitation and soft skills to work with cross functional teams
Day-To-Day Responsibilities:
  • 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 the 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 skills.
  • 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
  • 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 the 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 the client’s decision model (DAI).
  • 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
Top Must have Skill Sets:
  • Certified Project Manager. Project manager certifications required
  • Expert in Microsoft Project
  • Communication skills
  • Biotech experience
  • Quality experience
  • Smartsheet experience a plus
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



 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.



 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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