Senior CMC Project Manager (US)

Location
Boston, MA, United States
Posted
May 23, 2021
Ref
8EFF3FAA99
Discipline
Science/R&D, CMC
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Senior CMC Project Manager (US)

Location: Boston, US or home based (either EST or CST time zone)

Reporting to: Sr. Director, CMC Lifecycle Management

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Orchard Therapeutics, Ltd. (OTL) is looking for an individual to join the team responsible for planning, budgeting, integrating, tracking and communicating CMC activities for the Company's product development programs. This will include working with internal stakeholders, academic collaborators, strategic partners and the Company's designated Contract Development & Manufacturing Organizations (CDMOs) and Contract Testing Organizations (CTOs).

Responsibilities
  • Execute best project management practices for CMC activities
  • Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets
  • Facilitate problem-solving, contingency planning, and decision-making
  • Ensure linkage between strategy and operational activities
  • Co-ordinate cross-functional communication and integration
  • Other activities as may be assigned


Requirements

Job Requirements

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

Candidate must possess:
  • Minimum of five years of experience in the biotechnology and/or pharma industry with a primary focus on project management of CMC related activities
  • Solid understanding of biotech/pharma product development

Education & skills
  • A minimum BSc or equivalent in Biological Sciences, Bioengineering, or an associated discipline
  • A PMP or equivalent certification is advantageous
  • Experience of managing CDMO/CTO relationships and projects
  • Working knowledge of US regulatory requirements
  • Excellent interpersonal skills
  • Outstanding organizational skills
  • Excellent written and oral communication skills
  • Ability to operate in a fast-paced, multi-disciplinary corporate environment
Travel to Orchard, CDMO and CTO sites in US and/or EU will be required