CMC Program Manager - Innovative Gene Therapies
Reporting to: Associate Director, CMC Program Management
Location: Menlo Park, Ca
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
The CMC Program Manager will play a direct role in 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).
- Implement best project management practices for CMC activities
- Establish, document, track and communicate CMC timelines, objectives, deliverables and budgets
- Lead cross-functional project team meetings and drive on-time completion of deliverables
- 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
Candidate must possess:
- Solid understanding of biological product development phases
- Experience managing CMO/CTO relationships and projects
- Experience in the biotechnology or pharma industry with a primary focus on project/program management of CMC related activities
- Working knowledge of US and European regulatory requirements
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Travel to US and international CMO and CTO sites may be required
EDUCATION & SKILL REQUIREMENTS:
- A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
- Ability to demonstrate experience of integrated program/project management in the biotech/pharma industry
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
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
Notice to 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.