Associate Director, CMC Lifecycle Management
Location: London, UK
Reporting to: VP CMC Life Cycle Management
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Job summary
Key Elements and Responsibilities
- 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
- Interface with Research, Development, Commercial, Regulatory and 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
- Partner with Tech Ops and Commercial Distribution to ensure clinical and commercial supply and launch readiness
- Proactively track and ensure CMC milestones are delivered on-time and in-full, identify and escalate issues as appropriate and drive issue resolution
- Represent Tech Ops at program team level and own the bidirectional communications
- Demonstrated leadership and expertise in biopharmaceutical product and process development and commercialization
- A good team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships internally and externally
- Keep current on industry and regulatory trend especially in cell and gene therapy space
- Strong business acumen and awareness of healthcare policies and competitive market dynamics
- A go-getter and creative problem-solver with proven strategic and operational planning capabilities
- A superb communicator with an awareness of influencing behaviors in a cross-functional and global environment
- Resilient and able to work well under pressure, in a demanding, fast paced entrepreneurial environment
- BS degree in biological science or engineering disciplines, advanced degree advantageous, minimally 10 years of experience in biologics or pharmaceutical development
Requirements
Required knowledge
- Demonstrated leadership and expertise in biopharmaceutical product and process development and commercialization
- A good team player with a hands-on approach, able to quickly establish credibility, build rapport and trust and influence and maintain effective working relationships internally and externally
- Keep current on industry and regulatory trend especially in cell and gene therapy space
- Strongbusiness acumen and awareness of healthcare policies and competitive market dynamics
Skills amp; Abilities
- A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
- A go-getter and creative problem-solver with proven strategic and operational planning capabilities
- A superb communicator with an awareness of influencing behaviors in a cross-functional and global environment
- Resilient and able to work well under pressure, in a demanding, fast paced entrepreneurial environment
Education
- BS degree in biological science or engineering disciplines, advanced degree advantageous, minimally 10 years of experience in biologics or pharmaceutical development
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.