Vice President, Manufacturing and Site Head - FM3
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.
This position will be based in Orchard’s new site in Fremont, California. The Vice President and site head will ultimately be accountable for the Fremont site, overseeing all of the anticipated manufacturing operations and support functions. During the construction and start-up phase, the site head will be the on-site leader directly responsible for achievement of the project and start-up objectives that have been established for the facility. S/he will interface directly with regulatory agenciesto ensure the new facility is built-out, inspected and approved in a timely fashion.
- Develop and implement organization-wide and site-specific strategies for product development and manufacturing, ensure success of all production activities and projects including build-out, commissioning and qualification, facility start-up and reliable operations
- Responsible for long-range strategic planning for the Fremont site and contribute to the development and execution of Orchard’s manufacturing and supply chain strategy
- Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements
- Commit to safety and ensure ultimate workplace safety and security remains uncompromised
- Build a high performing team by recruiting and developing talent, ensuring the development and implementation of training required to fully qualify staff for Plant startup and routine operations
- Lead and develop a strong winning culture at the Fremont site, fostering teamwork and commitment to excellence through transparent communication and staff engagement
- Drive operational excellence, flawless execution and continuous improvement
- Site representative before the relevant State and local authorities and inhabitants
Requirements and Qualifications
- Demonstrated leadership and proven track record and expertise in biopharmaceutical facility design, construction and 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
- Strong understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls
- Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution
- Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor
- Excellent team player and be able to build and sustain organization respect and trust at all levels
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
- Resilient and able to work well in a demanding, fast paced entrepreneurial environment
- Sound judgement and business acumen with personal versatility and flexibility as business and team evolve
- Keeps current on professional knowledge, expertise and best practice
- BS or advanced degree in engineering disciplines with minimally 15 years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing leadership role in a GMP facility within the biotechnology or pharmaceutical industry
Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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