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Project Manager Senior – Biotech CMC LCM - Remote (JP9235)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Project Manager Senior – Biotech CMC LCM - Remote (JP9235)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: CMC Integration LCM PM group
Duration: 3 years (with possible conversion to permanent)
Posting Date: 09/30/2021


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 SPM should be a self-starter who independently manages multiple assigned projects in a fast paced, rapidly changing environment.
  • The SPM works with cross-functional teams to plan product development projects and proactively manages the execution of projects in compliance with client procedures.
  • The projects include (but are not limited to):
    • development and/or tech transfer of manufacturing processes and/or test procedures for biological and/or SM drugs and/or
    • executing the design control process for combination products
  • This SPM role requires strong verbal and written communication skills, critical thinking and strong analytical skills, particularly when unexpected issues occur that could impact the project schedule.

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

Top Must Have Skills:
  • 2+ years of experience as Project Manager.
  • 2+ years of experience as Project Manager or subject matter expert in:
    • Development and/or tech transfer of manufacturing processes and/or test procedures for biological and/or SM drugs and/or
    • Executing a design control process for combination products and/or medical devices
  • Good MS Project skills.

Day to Day Responsibilities:
  • Work with cross-functional teams to develop and maintain detailed Microsoft Project schedules and leverage the schedules to monitor project execution and guide the teams in prioritizing tasks, assessing and mitigating risks, compensating for unexpected issues, and completing projects on time.
  • Schedule and lead re-occurring cross-functional team meetings including SME’s from DS development, DP development, test method development (AS), Final Product Technologies, Quality, Regulatory, Supply Chain, Manufacturing, and from other functions as needed, to coordinate and align activities and responsibilities of the different functions. Write meeting minutes and distribute them to project teams and senior management as needed.
  • Schedule and facilitate cross-functional ad-hoc meetings and write meeting minutes as needed.
  • Prepare and facilitate cross-functional governance reviews with senior management including SVP’s. Guide the project team in preparing slides for governance meetings and present the timeline during the meetings. Create meeting minutes and upload them to the respective governance SharePoint site.
  • Provide project status updates to management via online tools.
  • Upload MS Project schedules to centralized database to allow comparisons across all projects.
  • Setup and manage team collaboration tools, such as SharePoint sites or box folders.

Basic Qualifications:
  • Strong hands-on Project Management skills.
  • Expertise in Microsoft Project
  • Drug Development experience.
  • Cross-functional team leadership

Employee Value Proposition:
  • Opportunity to work in the headquarter of a global fortune 500 biotechnology company.
  • Opportunity to work on product development projects that are intended to be commercialized.
  • Great visibility to senior leadership team via frequent governance meetings.

Red Flags:
  • Resume with multiple job durations of 18 month or less.
  • Little experience in biopharmaceutical, pharmaceutical, or medical device industry.
  • Little experience in managing cross-functional projects. (working in a PMO does not qualify)
  • Little experience with Microsoft Project.
  • No education in scientific or engineering area.

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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