Dir./Sr. Dir. CMC Lifecycle Management

Dir./Sr. Dir. CMC Lifecycle Management

Location: London, UK

Reporting to VP 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 a London-based team responsible for leading and managing the project management team within the CMC Lifecycle Management function. 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

CMC Program Management Leadership:

• Lead and manage the CMC project management team within the CMC LM function, consisting of both full-time employees and contractor/consultant resources. This includes selection, hiring, and training on company and department policies, systems, and processes
• Coach and develop direct reports by providing an environment that encourages ongoing personal and professional development through maintenance of Individual Personal Development plans
• Manage and ensure the setting of goals for the team and provide regular feedback throughout the year, including workload prioritization
• Responsible for the development coordination of global CMC project goals and driving standardization in the use of tools and processes in collaboration with the Program Management and other relevant functions
• Identify and escalate issues associated with team resourcing to functional management as appropriate
• Facilitate the integration of all key workstreams to support CMC program management
• Responsible for project management processes and lead improvement initiatives, best practices sharing, guiding team members to ensure consistency and transparency
• Identifies and implements standard methodologies/tools to drive continuous improvement by ensuring knowledge and experience exchange
• Develop, disseminate and publish relevant CMC program status report and dashboards to/for functional areas, management, and governance forums
• Other duties may be assigned

CMC Project Planning:

• Partner with the Program Team, CMC project teams to develop and oversee CMC strategic and tactical plan including operational plan, budget and resource allocation
• Ensure the CMC strategy and QTPP for all projects are established, consistent with overall product development strategy as derived from the Target Product Profile (TPP) and approved at the appropriate governance forums
• Oversee the development and maintenance of the cross functional timeline supporting the overall program strategy- highlighting dependencies, milestones, deliverables, and critical path; create timeline scenarios as needed and facilitate cross-functional reviews
• Facilitate team development and management of Program Risk Mitigation Plan ensuring execution and alignment of risk mitigation efforts
• Interprets and applies a strong understanding of the on-site processes and organization to make effective decisions and leading initiatives for the site in alignment with the department's strategy

Teck Ops Governance:

• Partners with Tech Ops leadership and CMC Teams on TOPG facilitation (e.g., meeting prep, post meeting follow-up, etc.).
• Facilitates effective decision making through consistent use of TOPG decision making process
• Facilitates LCM leadership forum (e.g., meeting prep, post meeting follow-up, etc.)

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 ten to fifteen 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
• People management experience
• Proficiency in program reporting and communication
• Ability to travel to EU CDMO and CTO sites, and as required US or other international sites
• Experience of commercializing Cell & Gene Therapy ATMPs is a distinct advantage

Education & skills

• A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline
• A master's degree in Science and business is advantageous
• A PMP or equivalent certification is a plus
• Experience of managing CDMO/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 is required. Some travel to US or other international sites may be required

For further information on this role do not hesitate to email HR@orchard-tx.com

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.