Project Manager, Diagnostics and Therapeutics Development

Location
Seattle, WA
Posted
Jun 19, 2022
Discipline
Quality, Quality Control
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

AltPep Corporation, a dynamic, biomedical start-up in Seattle, is seeking a highly motivated Project Manager to drive the development processes for life-changing diagnostics and therapeutics for Alzheimer’s Disease and other amyloid diseases. As the cross-functional team leader for multiple development projects, the Project Manager will seamlessly interface with internal resources, third parties, subject matter experts and senior management to guide the creation and execution of Product Development Plans. Using a deep understanding of AltPep’s technology and regulatory development processes, the Project Manager will ensure the achievement of project goals, milestones and timelines.

This is a unique opportunity to be one of the early members of a cutting-edge, growing organization, and be part of building the operating framework and company culture.

Responsibilities

  • Collaborate cross-functionally, with both internal and external resources, to successfully create, communicate and execute Product Development Plans
  • Develop timelines and actions associated with submissions to the FDA and other regulatory agencies, as appropriate
  • Develop resource plans and assist in procurement for projects, as needed
  • Analyze progress and, when necessary, seek approval for changes to planned scope, timelines, and costs to ensure that projects meet requirements
  • Identify and resolve or escalate program issues, facilitate trade-off decisions and remove obstacles
  • Define and build processes and tools for effective product development and project management
  • Ensure projects adhere to design controls and other applicable standards
  • Analyze, manage and escalate risks to enable successful project completion
  • Schedule and lead phase gate reviews leading to Executive Committee approval

Qualifications

Required

  • Bachelor’s degree in life sciences, engineering or similar
  • 4+ years life science project management experience
  • Proven ability to create and manage project schedules, including tasks, deliverables, milestones and schedules for highly complex projects
  • Strong experience facilitating project team meetings, cross-functional communication and decision-making to ensure alignment
  • Successful track record utilizing project management tools and software such as Smartsheet, Lucid Chart, MS Project, etc.
  • Highly collaborative and communicative style including relationship building across stakeholders
  • Strong written and verbal communication skills
  • Demonstrated problem-solving skills and sound judgement

Preferred

  • Regulated biotechnology experience (ISO, CLIA, GxP, etc)
  • IVD medical device knowledge including prior experience managing Design Control processes
  • PMP certification
  • Graduate degree (masters or PhD)

Benefits 

AltPep offers a competitive compensation package, including equity incentives, as well as a benefits program designed to support the well-being of our employees and their families. Benefits include medical, vision and dental coverage, and group life insurance. To learn more about us please visit www.altpep.com.

AltPep is an equal opportunity employer with the desire for diversity of all types. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, disability, or any other status protected by federal, state, or local law.

Job Type: Full-time; Must be authorized to work in the US.

Our Mission

Develop products for early diagnosis and treatment of the world’s most intractable diseases, starting first with Alzheimer’s Disease. Come join us!

Contact Info

HR@altpep.com