Senior Project Manager - CMC Integration LCM PM (JP4520)

Location: Thousand Oaks, Ca
Date Posted: 07-31-2018
Job Title: Senior Project Manager - CMC Integration LCM PM (JP4520)
Location: Thousand Oaks, Ca.
Duration: 3 years contract with possible extension or direct hire.
Business Unit: CMC Integration LCM PM
 
3Key Consulting Inc. is looking for role for a Senior Project Manager with 6+ years’ experience in project management of new drug product development and transfer of manufacturing processes with the biopharmaceutical of pharmaceutical industries.  This opportunity is for a global, CA-based, bio-pharmaceutical company. Ideal candidate would have 5-6 years of Project Management experience In Pharma/Bio space, has combination product and design control experience, and PM certification preferred. Candidate needs to be onsite at Thousand Oaks. Willing to travel at least 20% and willing to travel both International and Domestic.
 
Description 
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. 

Reporting into the Program Management Office within the Operations Life Cycle Management (LCM) organization, this role will support cross-functional teams from multiple Amgen sites, functions and external partners, to develop innovative drug products and/or delivery devices that are integrated with biologics to create drug/device combination products. 

Responsible for developing and maintaining project plans and schedules for life cycle projects which may include new formulations, new manufacturing processes, process transfers and new delivery devices. Working with the Global Operations Leader and other members of the Product Delivery Team, the Project Manager will ensure that plans and schedules for Process Development activities are aligned with business priorities. The role will ensure that associated project risks are captured, mitigation plans are and status is clearly communicated to impacted stakeholders. The PM will assist in driving timely decision making for the project and will ensure that action items are captured and tracked to completion. Partner with process development technical leads to identify key deliverables and activities to be completed by functional teams. This will include identification of dependencies and optimizing the sequence of activities. The Project Manager will ensure cross functional alignment and integration of interdependent activities via cross functional communication of plans and timeline with specific emphasis on critical path activities. Assist the technical leads with tracking the completion of required technical deliverables via dashboards and reporting on project metrics.
 
  • Support projects that utilize internal and external personnel, contract firms, and partners 
  • Support combination product development programs utilizing structured, systematic methodologies to meet cost and schedule objectives 
  • Follow Amgen’s governance processes, procedures, specifications, design controls, and applicable compliance standards and guidance documents 
  • Responsible for integrating Process Development activities by developing and maintaining detailed project schedules for Amgen pipeline and biosimilar projects. 
  • The Project Manager will partner with Process Development functional leads to identify key deliverables and will ensure cross functional alignment and accountability. 
  • Negotiate and resolve conflicts and drive decisions among team/functional members to accomplish project and business goals 
  • Assist the Process Development Organization in driving decisions by using the Decision Making Framework (D- Decision maker, A- Advice Giver, I- Informed) 
  • Ensure participation in functional and cross-functional management reviews 
  • Establish and manage collaboration and team sites (e.g. SharePoint) 
  • Manage and prioritize support of multiple project teams at one time 
  • Provide meeting facilitation, including development of meeting agenda and minutes 
  • Accurately capture and monitoring status of action items through effective tracking tools and communication of progress 
  • Track delivery and create repositories for all Process Development deliverables 
  • Facilitate and incorporate lessons learned, best practices, etc. 
  • Support Business Process improvements, including alignment with Chemistry, Manufacturing, and Controls excellence (CMCX) 
  • Deep understanding of and experience with disciplined product development processes (phase/gate product development method) 
  • Experience developing products that are manufactured at high volumes using automated and semi-automated manufacturing processes 
  • Experienced in creating and maintaining a Design History File 
  • Project reporting including appropriate risk analysis 
  • Proven ability to manage in a highly fluid, interactive, matrixed environment 
  • Experience with MS Office, Project, Excel and SharePoint 
  • 20% travel domestic and international 
     

Basic Qualifications: 
Doctorate degree & 2 years of Project Management experience OR Master’s degree & 3 years of Project Management experience OR Bachelor’s degree or & 5 years of Project Management experience OR Associate’s degree & 8 years of Project Management experience OR High school diploma / GED & 12 years of Project Management experience 


Preferred Qualifications: 
  • PMP Certification 
  • 5 years+ of project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct CMC experience is highly desirable 
  • Experience successfully developing and launching commercially viable pharmaceutical or combination drug/device products from concept to commercialization 
  • Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time 
  • Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision making skills 
  • Experience with performing critical path analysis 
  • Critical thinking and problem solving skills 
  • Quick learner, proactive, takes initiative 
  • Distinguishes proper balance between strategic and tactical thinking 
  • Strong experience with Project Management tools, methodologies, and practices 
  • Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analysis and influence decision-making
 

Must Have Skill Sets:
  1. Extensive experience (5-6 years) in Combination Product Development
  2. Experience successfully developing and launching commercially viable pharmaceutical or combination drug/device products from concept to commercialization
  3. Experience in DS & DP Product Development Lifecycle Management
  4. EXPERT in Critical Path Analysis and Microsoft Project-
 
This person needs to be able to explain how to identify the critical path/ what the critical path is and fully walk the manager through using Microsoft Project in their interview as it is a vital part of being successful in this role.
 
Day to Day Responsibilities:
Support cross-functional teams from multiple Amgen sites, functions and partners by tracking the completion of required technical deliverables Develop and maintain project plans and schedules Conduct scenario planning Ensure cross functional alignment and integration of interdependent activities via cross functional communication of plans and timelines with specific emphasis on critical path activities Establish and manage collaboration and team sites Provide meeting facilitation, including development of meeting agenda and minutes
 
Employee Value Proposition:
The employee would get the opportunity to gain knowledge and experience in Drug Substance, Drug Product and Combination Product Development on innovative human therapies. They would experience what it is like to work with world class product development teams, contract firms, and partners. Learn how to be a leader in a highly fluid, interactive, matrixed environment. While continuing to develop, and strengthen their project management skill set and Bio-pharmaceutical experience

Red Flags:
  • Candidates whose professional career experience is from any of the following industries:
  • IS/IT Program/Project Management
  • Aerospace Program/Project Management
  • Automotive Program/Project Management
  • Banking Industry Program/Project Management
  • Food Industry Program/Project Management
  • Not an EXPERT in MS Project
  • Errors on resume- Please proofread the resume before you submit
 
Interview Process: Phone followed by panel in-person interview(s)
 

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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