CMC Associate Project Manager - Innovative Gene Therapy Start Up

Menlo Park, California, United States · CMC expand job description ↓

Description


Reporting to: Associate Director CMC Program Management

The CMC Associate Project Manager will support planning, budgeting, integrating, tracking and communicating CMC activities for the Company’s product development programs. This will include working with internal stakeholders, academic partners and the Company’s designated Contract Manufacturing Organizations (CMOs)

Responsibilities

  • Utilize project management tools and best practices to support CMC activities
  • Document, track and communicate progress against CMC timelines, milestones and budgets
  • Assist with cross-functional project team meetings and drive on-time completion of deliverables
  • Facilitate problem-solving, contingency planning, and decision-making
  • Co-ordinate and track status of cross-functional communication and integration activities
  • Other activities as may be assigned

Requirements

The ideal candidate for this position will have demonstrated experience of integrated program/project management in the biotech/pharma industry.

Candidate must possess:

  • A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
  • Experience in the biotechnology or pharma industry with a primary focus on project/program management of CMC related activities
  • Familiarity with biological product development phases and regulatory requirements

Education & skills

  • Experience managing CMO/CTO relationships and projects desired
  • Working knowledge of US and European regulatory requirements
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Travel to US and international CMO and CTO sites may be required

Benefits

Platinum Healthcare Coverage, Dental and Vision, 401 (k) Safe Harbor Plan, Life Insurance and more including competitive Salary, Bonus and Equity scheme (role dependent).

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