Senior Director, Engineering - FM5
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 in engineering, capital project and facility operations to lead the design, construction, commissioning and qualification the company’s new process development and GMP manufacturing facility in the San Francisco Bay Area, CA. Upon the completion of the capital project, this individual will transition to facility and engineering support to the day-to-day operations of both non-GMP and GMP activities at the site.
- Oversee design, construction, commissioning and qualification of the company’s new GMP manufacturing facility
- Ensure facility design is compliant with regulatory requirement, meet demand forecast and enable efficient development and GMP operations
- Interface with A&E firm, general contractors and sub-contractors to deliver capital project on-time and within the budget
- Manage construction activities and ensure safety of the staff and contract works
- Collaborate with Process Development, Manufacturing, Quality and other functional areas to deliver successful facility start-up
- Once commissioned, ensure the facility and equipment operates in compliance with applicable international, federal, state, city regulations and company policies and procedures
- Recruit and develop the best facility and engineering team to support the operations and future capital projects
- Implement and maintain best business and engineering practices, drive continuous improvement
- Develop and execute long term facility and engineering strategy to enable global growth
Requirements and Qualifications
- Demonstrated leadership and proven track record and expertise in engineering, capital project and facility operations
- 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 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 ability to prioritize and focus on high impactful areas
- Highly effective communicator with an awareness of influencing behaviors in a global environment
- Resilient and able to work well under pressure, in a demanding, fast paced entrepreneurial environment
- Keeps current on professional knowledge, expertise and best practice
- BS or advanced degree in engineering disciplines with extensive years of relevant experience in biotech or pharmaceutical industries
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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