Akero Therapeutics

Restoring Balance. Renewing Life.

Manager, CMC Project Management

Project ManagerProject ManagerFull TimeRemoteTeam 11-50Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

6 days ago

Salary

$120.3K - $222.6K / year

Bachelor Degree4 yrs expEnglishPMP

Job Description

• Oversee and drive CMC project plans, ensuring deliverables align with the overall project objectives and timelines • Facilitate cross-functional collaboration by leading CMC sub-team meetings, preparing agendas, tracking action items, and maintaining meeting minutes. • Partner with Technical Operations, Legal, and Finance to negotiate and execute confidentiality agreements, consulting agreements, master service agreements, and work orders with CDMOs and CROs, following internal procedures. • Oversee development and execution of integrated project plans, including timelines, budgets, and resource allocation across multiple workstreams. • Partner with Technical Operations, Legal, Finance, and external CDMOs/CROs to negotiate and finalize agreements, ensuring compliance and timely execution. • Monitor and manage project budgets, forecast resource needs, and provide financial oversight to support decision-making. • Proactively identify and mitigate risks, maintaining risk registers and implementing contingency strategies to ensure program success. • Deliver high-quality reporting and communication, including executive-level updates, dashboards, and presentations for governance forums. • Champion process improvements and best practices, driving operational efficiency and consistency across Technical Operations projects. • Other responsibilities may be assigned as required by management

Job Requirements

  • BS degree required
  • Degree in life sciences/engineering strongly preferred, professional certifications (i.e. PMP) will be a distinct advantage
  • 4+ years of experience supporting Technical Operations (Manufacturing, Analytical/QC testing, Packaging, Distribution)
  • Device Development experience highly desired
  • Excellent communication skills (both verbal and written) and interpersonal skills are required
  • Works well independently as well as in a team environment
  • Highly proficient in Microsoft Office applications and Smartsheet; comfortable and quick learner with other software systems
  • Demonstrates collaborative communication and problem-solving spirit.
  • Willingness to do what needs to be done in a dynamic environment.

Benefits

  • medical, dental and vision coverage
  • life insurance
  • disability insurance
  • 401(k) savings plan
  • flexible spending accounts
  • employee assistance program
  • tuition reimbursement program
  • voluntary benefits such as group legal
  • critical illness
  • identity theft protection
  • pet insurance
  • auto/home insurance
  • sick time policy
  • flexible vacation policy
  • parental leave policy

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