CMC Project Manager Req# 2107

Encoded Therapeutics

Raleigh, NC, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 02/15/2021
  • Website: encoded.com
  • Company Address: 343 Oyster Point Blvd., Suite 100, South San Francisco, CA, 94080

About Encoded Therapeutics

A New Paradigm

Current treatment paradigms often address the symptoms of disease, not the cause, thus requiring chronic management. At Encoded, we leverage the power of the human genome to deliver highly effective precision therapies, leading to life-changing and lasting benefit for individuals with genetic disorders.

Job Description

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

We are recruiting for a CMC project manager to join our team to support planning, budgeting, tracking and communication across functional groups for Encoded’s AAV gene therapy programs. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work closely with both internal groups and the Company’s designated Contract Manufacturing and Contract Research Organizations (“CMO/CRO”). This position requires a highly motivated self-starter with a strong PM and technical background who can assimilate new information quickly. This individual will report to the Program Management Office and will utilize established PM tools and help further identify tools and processes needed to support successful development and delivery of Encoded research and development programs.

Responsibilities

  • Partner with the Project Team Lead to identify risks, mitigations and ensure timely problem solving and communication.
  • Support cross-functional CMC project team and sub-teams in development of integrated timelines, planning and executing on development of AAV gene therapy products (IND through Phase I/II/III and launch).
  • Partner with PM organization to establish and/or refine standard project management processes, systems, and tools.
  • Drive execution of all stages of the CMC plan in partnership with functional leads and Project Team Lead as needed.
  • Facilitate communication within the CMC project team and sub-teams to identify risks, mitigations and communicate as appropriate.
  • Partner with Project Team Lead to ensure CMC functions are properly prepared for internal meetings, communications to management and engagement with the cross-functional CMC teams & Core Team as needed.
  • Utilize formal communication protocols and tools including dashboards, progress reports, weekly/monthly updates, and any other specific information as needed for internal use and for CMO/CRO engagement to help achieve company and operational goals.
  • Drive risk management including conducting cross-functional or functional team level program risk assessments and scenario planning to understand impact and sensitivity of issues and plans.
  • Partner with Project Team Lead to proactively drive the development of CMC contingency and/or risk mitigation plans & integrate with the Program Plan.

Requirements

  • Bachelor’s degree in Science or Engineering and 9 or more years of hands-on client-facing project management experience and training in biotechnology/pharmaceutical industries.
  • 5 or more years experience with CMC, Clinical, Regulatory and pre-Clinical development.
  • Experience in CMC tech transfers, manufacturing, quality systems, CMO management pre-clinical & clinical development and understanding of regulatory requirements.
  • Excellent communication, team management and conflict resolution skills.
  • Excellent written and oral communication skills both internal and external.
  • Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment.
  • Strong client-facing interpersonal skills coupled with a concern for impact. Rational Persuasion.
  • Strong time management and organizational skills.
  • Ability to multi-task in a fast-paced environment.
  • Attention to details and concern for standards.
  • Identify and mitigate potential project risks with the team and develop mitigation strategies.
  • Communicate program status, progress, risks including elevation of issues as needed, to key internal and external stakeholders.
  • Ability to resolve conflict within project teams and know when to escalate if needed.
  • Proficient utilizing MS Office Suite, specifically MS Project, Smart Sheets, PowerPoint, etc.
  • Up to 20% Travel may be required.

Preferred Qualifications:

  • Master's degree in Science or Engineering and 7 or more years of hands-on client-facing project management experience and training in biotechnology/pharmaceutical industries
  • PMP Certification
  • Gene therapy experience

 

Benefits

  • Comprehensive benefits package, including competitive employer premium contributions
  • Meaningful stock option grants
  • PTO, sick time and holiday pay
  • Generous Parental Leave program
  • Pre-tax medical and dependent care programs
  • STD, LTD, Life and AD&D
  • Professional development opportunities
  • Team-building events
  • Fully stocked kitchen
  • Purple Tie dry cleaning service
  • Fitness center

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.