Senior Project Manager Drug Substance/Product Manufacturing (JP4349)

Location: Thousand Oaks, CA
Date Posted: 06-07-2018
Job Title: Senior Project Manager Drug Substance/Product Manufacturing (JP4349)
Location: Thousand Oaks, CA
Employment Type:  Contract
Business Unit:   CMC Integration LCM PM
Duration:  2+ years (likely extensions or conversion to permanent FTE)
3Key Consulting Inc. is looking for role for a Senior Project Manager with 4+ years’ experience in project management of new product development and transfer of manufacturing processes with the biopharmaceutical of pharmaceutical industries.  This opportunity is for a global, CA-based, bio-pharmaceutical company.
Job Description:
The Sr. Project Manager (SPM) independently plans and manages the execution of projects to develop or transfer manufacturing processes and test methods for biopharmaceutical products. Project responsibilities start at the end of Phase 1 studies and end with a regulatory filing or a commercial launch. Usually the project scope includes the development or transfer of large scale manufacturing processes and analytical test methods for DS and DP, and occasionally the design and development of delivery devices.
Top Must-Have
  • 4+ years of hands-on Project Management experience including:
  • New product development projects.
  • Development or transfer of drug manufacturing processes within the Biopharmaceutical or Pharmaceutical industry.
  • Strong skills to leverage MS Project to pro-actively guide project teams in the timely execution of projects, for example by providing clear priorities of the various tasks to the team.
  • Combination of strong verbal and written communication skills.
Basic Qualifications:
  • 4+ years of hands-on Project Management experience including.
  • New product development projects.
  • Development or transfer of drug manufacturing processes within the Biopharmaceutical or Pharmaceutical industry.
  • Strong MS Project skills.
  • Strong analytical, critical thinking, and problem-solving skills.
  • Ability to self-start and independently manage product development projects within Biotechnology.
  • Ability to work effectively in a fast paced, rapidly changing technology environment, and to manage activities from DS, DP, and AS simultaneously.
  • Ability to foster collaboration and work effectively on cross-functional teams.
  • Experienced with MS Office.
  • Very good verbal and written communication skills as well as good interpersonal skills.
Day to Day Responsibilities:
  • Working closely with the team leads for Drug Substance (DS), Drug Product (DP), and Attribute Science (AS) to ensure projects are planned appropriately, executed in compliance with Amgen procedures, and completed on time within the resource constraints.
  • Developing detailed MS Project schedules which are based on input from the functional leaders and team members from DS, DP and AS and which reflect the dependencies of the individual tasks. Leveraging MS Project schedules to plan and manage the execution of the projects.
  • Partnering with the functional leaders to identify and manage risks, and ensure cross functional alignment and accountability throughout the entire project.
  • Communicating vertically and horizontally across many levels and functions within Amgen.
  • Depending on the assigned project the SPM might work with Global Operations Leads, Regulatory Leads, Product Quality Leads, Product Delivery Teams, and other stakeholders.
  • Scheduling and moderating cross-functional team meetings and creating meeting minutes that are frequently distributed to SVP level management.
  • Establishing and/or managing collaboration and team sites (SharePoint, box, etc.).
  • Establishing and maintaining project control tools and pro-actively monitoring project progress.
  • Work with cross-functional teams within the Process Development (PD) organization in executing projects in compliance with regulations and on time. The projects can be Late Stage Development or Lifecycle Management projects.
  • The projects may include the development of drug substance, drug product, analytical test methods, and/or combination products.
  • The core responsibilities are:
  • Develop and maintain detailed project schedules in close cooperation with project teams.
  • Support project teams to execute projects on time.
  • Support project teams in project execution by setting up teamwork tools (e.g. network sites and folders).
  • Establish and maintain project control tools and pro-actively monitor project progress.
  • Provide written and verbal project status updates to PD Senior Management.
  • The candidate should be a self-starter who can independently projects within PD.
  • The position will require flexibility and fast learning skills to adapt well in a dynamic environment with changing challenges.
  • Additional responsibilities (depending on the assigned project):
  • Planning, preparing, and facilitating functional and cross-functional management reviews.
  • Providing guidance for project teams to identify the best approach to complete projects on time, to overcome obstacles, or to react to scope, resource, or timeline changes.
  • Traveling to other Amgen facilities or external partners as needed.
Why This Position Is Open:
Supplement additional workload on team.
Employee Value Proposition:
  • This position provides the opportunity to work in the headquarter of a global fortune 500 company.
  • Offers a fantastic opportunity to work on molecules that have successfully completed Pre-Pivotal studies and, thus, were selected and have a high chance to be commercialized.
  • Involves frequent governance meetings which offer a good visibility to the senior leadership team within Process Development.
  • Offers a great opportunity for Project Managers who would like to move from Contract Manufacturing Organizations to a company that develops large scale manufacturing processes by itself and transfers these to internal and external clinical and commercial sites.
  • Provides the opportunity to work with some of the newest and most innovative technologies in Biopharmaceutical manufacturing.
  • Offers opportunity to work cross-functionally with the team leads from Drug Substance, Drug Product, and Attribute Sciences.
  • Provides a very dynamic environment where changes are more the norm than the exception.
  • Offers chance to join a well-recognized team of a very talented and experienced Project Managers.
  • This role has the potential to convert into a full time position.
Red Flags:
  • Resume with multiple short duration jobs of 18 month or less.
  • No or little experience in Biotechnology / Pharmaceutical industry.
  • No or little experience as Project Manager of new product development projects.
  • No or little experience with Microsoft Project.
  • No education in scientific or engineering area.
Interview process:
  • Phone screening interviews with Amgen as soon as possible.
  • The best 2 or 3 candidates will be invited to in-person interviews at ATO.
3KC Talent Acquisition Team
this job portal is powered by CATS