Associate Director, CMC Lead - FM6
Menlo Park, California, United States
Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare disease through innovative gene therapies.
Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion-dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.
We are looking for an established leader with experience in biopharmaceutical development to lead the development and execution of CMC strategy to commercialize Orchard’s transformative gene therapy products.
- 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
- 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
- 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
- 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
- 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
- BS degree in biological science or engineering disciplines, advanced degree advantageous, proven extensive years of experience in biologics or pharmaceutical development
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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