Associate Director, CMC Project Manager, Gene Therapy AAV

Position Summary

Associate Director, Chemistry, Manufacturing, and Controls – Project Manager

Rocket is seeking an Associate Director, CMC Project Manager who will proactively manage multiple CMC projects coordinating with key internal and external stakeholders to advance our transformative portfolio of adeno-associated virus (AAV) programs for rare and life-threatening hematopoietic disorders. The primary responsibility of this position is to work collaboratively with a focus on effective communication, planning, coordination of activities, and efficient implementation of the CMC development and supply strategy. This will include working with internal CMC, clinical, and regulatory groups, external academic partners, and Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs). The ideal candidate for this position will have demonstrated experience of integrated program/project management preferably in the biotechnology/biopharma industry.

Primary Responsibilities:

  • Develop CMC project plans for multiple existing and envisioned projects
  • Establish, document, track and communicate CMC timelines, objectives, deliverables, and budgets
  • Create project communication tools, such as project dashboards, CMC team meeting minutes and summaries, resource and time line plans and staffing to accomplish these plans
  • Assist with cross-functional project team meetings and drive on-time completion of deliverables
  • Facilitate project discussions to ensure progress and identify appropriate team actions and risks
  • Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
  • Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate

Education/Experience and Skills Requirements:

  • Bachelor’s degree in Biological Sciences, Bioengineering, or an associated discipline with 2 years of direct CMC/AAV related experience
  • Project Manager Professional (PMP) certificate or MBA is preferred
  • Experience in the biotechnology or biopharma industry with a primary focus on project/program management of CMC related activities
  • Experience utilizing project management tools and best practices to support CMC activities
  • Experience managing CMO/CRO relationships and projects
  • Familiarity with biological drug product development phases and regulatory requirements
  • Working knowledge of US and European regulatory requirements
  • Ensure linkage between strategy and operational activities
  • Excellent written and verbal communication skills, analytic and problem-solving capabilities are essential

Location: Cranbury, NJ

EEOC

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

About Rocket Pharma

Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.

Search Firm Representatives Please Read Carefully

Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.

*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.

Interested in joining our team?

Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com