Program Manager at Pattern Bioscience | Powderkeg

Location: Austin, TX

Employment Type: Full-time

Team: Program Management

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.

To enable our bacterial ID/AST IVD product development to commercial launch and support future collaborations and products, we're seeking a strategic Program Manager with experience with IVD development . In this role, you will centralize efforts to plan and coordinate dependences within and across teams, interacting with Assay and Instrument R&D, Clinical Affairs, Manufacturing, Quality, Regulatory, etc. You will help oversee and coordinate the projects, products, and other strategic initiatives across the organization. Besides typical project manager responsibilities, you will contribute a high-level understanding of both current and future project components, empowering teams to make forward progress. This role is for you if you enjoy reducing friction in processes and communication in service of meeting ambitious goals.

Goals

  • 90 Day: Have a grasp on the scope and stage of the program, working with the different teams to manage the Critical Path schedule and sub-schedules
  • 90 Day: Develop a detailed list of tasks necessary to execute Pneumonia assay clinical trials
  • 90 Day: Validation Gate Review scheduled and executed
  • 180 Day: Develop a well-defined plan for execution of design verification and validation efforts and materials, in collaboration with teams across the organization
  • 180 Day: Understand the scope and timing of on-market software changes, in partnership with the software team
  • 180 Day: Kickoff planning activities associated with new assay development

How You Will Contribute

  • Collaborate with Core Team members to manage the Critical Path and sub-team schedules and meet development milestones, leading formal Core Team meetings
  • Keep lines of communication flowing between teams and management
  • Empower teams to complete design and development plan deliverables
  • Keep our development schedule on track and up to date, anticipating bottlenecks and possible resourcing issues, especially between the main project, feasibility studies, and external collaborations
  • Initiate product design and development process reviews
  • Collaborate with Supply Chain and Manufacturing to ensure material availability

We'd Love to Hear from You If You

  • Have a strong grasp of program manager fundamentals, tools, and best practices especially as applied in IVD medical device development lifecycles
  • Give clear written and verbal directions with a high level of accuracy
  • Enjoy being self-directed and independent
  • Comfortably manage conflict, ambiguity, change and uncertainty, especially when navigating unknown solutions to science-based problems
  • Know how to navigate complex scheduling issues and negotiate with multiple stakeholders across diverse functions to achieve consensus
  • Lead others to understand and accept values, strategies, goals, and plans in response to changing business conditions
  • Excel in planning and organizing yourself and groups of people without always having formal authority, with strong attention to detail and communication skills, following up with open issues positively and diligently
  • Love growing, learning, and improving processes

Desired Education & Experience

  • B.S. in life sciences, engineering, or related field
  • 3+ years as a Program Manager

Plus One or More of the Following

  • PMP Certification
  • Familiarity with medical device quality management system requirements (21 CFR 820)
  • Familiarity with ISO 62304 software development standards
  • Experience with multi-disciplinary development programs (assays, hardware, and software)
  • Knowledge of clinical trial processes and the commercialization/launch of medical devices

Application Instructions: In lieu of customizing your resume or writing a cover letter, we have a questionnaire to complete that allows you to demonstrate how your experience directly aligns with what we're seeking in the role.

Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.

Benefits

  • Health insurance

  • 401k Matching

  • Paid Time Off

  • The opportunity to make a global impact

To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.

We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Job Summary
  • Job Title
    Program Manager
  • Company
    Pattern Bioscience
  • Location
    Austin, TX
  • Employment Type
    Full time
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