CMC Product Lead (Director/Senior Director)

Location: London/Boston

Reporting to: VP CMC Lifecycle Management

Job summary

We are looking for an established leader with extensive experience in biopharmaceutical development to lead the development and execution of CMC strategy to commercialize Orchard's transformative gene therapy products.

Key Elements and Responsibilities

Reporting to CMC Lifecycle Management, serve as a product champion within Tech Ops and be accountable for development and execution of the CMC strategy in support of the overall product strategy. Lead a cross-functional team and oversee the planning, coordination and execution of process development and commercialization activities.

Partner with CMC project management to establish project timeline, milestones, risk register and mitigation plan to be aligned with overall program objectives and timeline. Proactively interface with Research, Cell & Gene Therapy Technologies, Commercial, Regulatory and other Tech Ops functions to ensure TPP and QTTP are well defined and appropriately incorporated into the development activities.

Collaborate with Tech Ops functional leaders to allocate resources and budget to ensure successful delivery of CMC milestones from development to product launch and post approval variation management; anticipate bottlenecks and/or resource issues and escalate accordingly. Partner with Global Supply Chain & Business Operations, and CMC Launch Lead to ensure both clinical and commercial supply and plan for launch readiness. Proactively track and ensure CMC milestones are delivered on-time and in-full, identify and escalate issues as appropriate and own the process to drive issue resolution.

Demonstrate excellent oral and written communication of complex information to executives, peers and regulatory agencies. Represent Tech Ops at Program Strategy Team level and own the bidirectional communications between Tech Ops and the Extended Program Team. Provide support and guidance to emerging and/or part-time CMC Leads.

Requirements

Required knowledge

Industry experience in the Pharmaceutical sector developing ATMPs (experience with HSCs and Gene Therapies would be advantageous).

Skills & Abilities

Setting Strategy

*Takes the lead to interact and collaborate cross-functionally on broader Technical Operations CMC strategy and decisions

*Proactively seeks and analyzes data from a variety of sources to support decisions

*Takes an entrepreneurial and creative approach to developing new, innovative ideas that will optimize and challenge the status quo to deliver better results

Executing for Results

*Sets clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results

*Comfortable with ambiguity and uncertainty; confident to make decisions through complex situations

*Makes excellent decisions regarding complex issues and communicates decisions effectively with internal stakeholders, elevating complex issues as appropriate

* Self-reflective and leads by example; drives the organization's performance with an attitude for continuous improvement by being open to constructive feedback and self-improvement

Collaborations and Influence

*Creates collaborative and trusting relationships internally and with external partners

*Excellent verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues

*Encourages others to share the spotlight and celebrates and supports the success of the team

Education

Min BSc., plus MSc/PhD or equivalent industry experience. 10-15+ years industry experience.