Associate Director, CMC Program Management (US)

Location: Menlo Park, CA USA

Reporting to: Vice President, CMC Program 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 Associate Director, CMC Program Management to lead a globally-based 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 Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs) in Europe and the US.

Requirements

Responsibilities

• Lead and facilitate cross functional CMC teams to plan, coordinate and execute deliverables to meet program team objectives while ensuring linkage between strategy and operational activities.
• Serve as primary point of contact with counterpart project manager(s) at contract manufacturing organization(s)
• Supervise and provide mentorship and development of program manager(s), project manager(s).
• Recommend and implement best practices for project management
• Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets
• Facilitate problem-solving, contingency planning, and decision-making
• Other activities as may be assigned

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 10 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 and regulatory requirements

• Ability to travel to EU CMO and CTO sites, and as required US or other international sites, ~25%
• A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline
• A PMP certification or equivalent experience
• Experience of managing CMO/CTO relationships and projects
• Working knowledge of US and European regulatory requirements,
• Experience with Advanced Medicines/ Gene Therapies a plus
• Excellent interpersonal skills
• Outstanding organizational skills
• Excellent written and oral communication skills
• Ability to operate in a fast-paced, multi-disciplinary industrial environment

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

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.