Senior Project Manager (Contract Development Manufacturing Organisation)

Location: London, UK

Reporting to: Associate Director External Development and Manufacturing (London) with dotted line reporting to the Sr. Director, CMC Lifecycle Management (London)

Permanent Position

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 a London-based team responsible for planning, budgeting, integrating, tracking, communicating and managing CDMO activities for the Orchard 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 CDMO activities
• Actively manage the CDMO FTE budgets and CDMO outputs
• Work closely with CMC project management to ensure alignment with all programme goals
• Establish, document, track and communicate CDMO 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 integrated program/project management in the biotech/pharma industry.

Candidate must possess:

Minimum of five years of experience in the biotechnology or pharma industry with a primary focus on project/program management of CMC related activities

Solid understanding of biological product development phases

Education & skills

A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline

A PMP or equivalent certification

Experience of managing CMO/CTO relationships and projects

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 EU CMO and CTO sites may be required. Some travel

RECRUITERS

All employment offers and CV's are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.