Senior Project Manager, External Development and Manufacturing
Location: Location: London, UK
Reporting to: Associate Director External Development and Manufacturing (London) with dotted line reporting to the Sr. Director, CMC Lifecycle Management (London)
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 that are integral to the supply of Orchard's clinical and commercial ex vivo cell therapies. This role will include working with internal stakeholders, academic collaborators, strategic partners and the Company's designated Contract Development & Manufacturing Organizations (CDMOs).
Key Elements and Responsibilities
- Execute best project management practices for CDMO activities
- Actively manage the CDMO FTE budgets, activity forecasting and CDMO outputs, and supporting CDMO with activity scheduling and prioritizing resource
- Develop a good understanding of the CDMO's organizational structures and relationships with other key stakeholders. Maintain high visibility within the CDMO organization and a positive CDMO relationship to drive successful business outcomes
- Develop close relationships with the OTL CDMO team to help identifying potential issues before they arise.
- Proactively set a cadence for contacts, meetings and follow-ups. Ensure all relevant meetings are formally recorded, circulated and acted upon.
- Support efforts to increase alignment, mutual understanding, and trust between OTL Technical Operations teams and the CDMO
- Work closely with OTL 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
- Support Manufacturing, Global Supply chain and Commercial teams to facilitate manufacture and supply of gene-modified cell-based therapeutic products
- Other activities as may be assigned
- Minimum of five years of experience in the biotechnology or pharma industry
- The ideal candidate for this position will have demonstrated experience of integrated program/project management in of CMC related activities
- Good understanding of biological product development phases
- Working knowledge of US and European regulatory requirements
Skills & Abilities
- Experience of managing CDMO relationships and projects
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Some travel to EU CDMO sites will be required
- A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline
PMP or equivalent certification
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
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.