Director, Manufacturing Science & Technology

Location: US, Remote, Boston or California

Reporting to: VP, Cell and Gene Therapy and Technologies

Orchard Therapeutics (www.orchard-tx.com), is global, fully integrated biotech company. Orchard's mission is to transform the lives of patients with rare diseases through innovative gene therapies. The company is developing ex-vivo autologous hematopoietic stem cell gene therapy to restore normal gene function in primary immune deficiencies, metabolic diseases, and hematological disorders.

We are open for this role to be based preferably in Boston, Massachusetts or the Bay Area, California with an option for the role to also be remote.

Orchard has a deep pipeline clinical-stage transformative gene therapies, one approved product and multiple preclinical programs. Data from the clinical studies show profound efficacy and multi-year durability with >150 patients treated. The company has built capabilities and established partners to manufacture and deliver near-term products globally, with commercial opportunities in excess of $1 billion annually across the 5 lead clinical indications.

Job summary

We are looking for an established leader in the fields of cell and gene therapy and/or biologics development to lead our US MSAT team. Reporting to Vice President Cell & Gene Therapy Technologies, the incumbent will play a key role in clinical pipeline development and commercialization at Orchard, including leading the tech transfer and manufacturing support of both vector and cell therapy products at a US CDMO and later on, an Orchard US facility. The ideal candidate has demonstrated leadership and knowledge in process development, characterization, validation as well as regulatory filing, inspection and facility licensure. This is highly visible leadership position to support facility design and construction, develop facility start-up strategy, represent Orchard in regulatory inspections and ensure successful tech transfer and facility licensure.

Key Elements and Responsibilities

• Build a strong MSAT team and lead tech transfer, process validation at a US CDMO
• Partner with Manufacturing and Quality organizations to establish the state of process control
• Lead data analytics and implement network wide Continuous Process Verification (CPV) program in collaboration with EU MSAT team
• Provide technical support manufacturing operations, proactively communicate and drive improve-ment of manufacturing process performance
• Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies

• Serve as a subject matter expert, author and/or review technical reports and relevant sections of CMC documentation in support of regulatory submissions and amendments as well as meetings with regulatory authorities

• Actively support inspection readiness activities and associated Health Authority Inspections

• Build, modify, and utilize digital data storage, visualization, and analysis systems to enable CPV pro-gram

• Provide leadership for defining and developing the next generation of production technologies and capabilities

• Develop, maintain and implement internal and external processes to meet regulatory requirements

• Ensure internal and external capabilities, skills, and capacities meet Orchard's requirements and drive acceleration of robust pipeline progression with clear understanding of risk and trade offs

• Develop functional specific SOPs and standards in support of the Quality System and proactive qual-ity improvement

• Instill scientific rigor and enhance process knowledge across the organizations

• Manage and oversee all aspects of organizational performance and development

• Establish regular interface and build strong connections with the internal team in US and Europe as well as external partners including Face to Face meetings and teleconferences

Requirements

Qualifications and Skills

• PhD/MS in relevant Science or Engineering with minimum 15 years of industry experience including leading a team of process scientists and engineers
• Strong knowledge of GMP compliance, regulations and manufacturing operations. Experience in cell therapy is a plus
• Strong working knowledge and interpretation of FDA/EU and ICH regulations and guidelines with direct experience in tech transfer, process validation and comparability
• Broad and direct experience with regulatory authority inspections, including both FDA and EMA in-spections
• Track record of delivering results, having a bias for action, and translating strategy to implementa-tion
• Experience in directly managing and mentoring high performing and diverse teams across strategy, planning and implementation
• Strong prioritization skills with a demonstrated ability to manage at team that excels across multiple projects amidst a fast-paced, cross-functional, results-oriented work environment
• Strong verbal and written communication skills. Ability to communicate effectively with others inter-nally and externally to the organization
• Demonstrate effective decision making, good judgement and constructive escalation
• Consistently anticipate and proposes solutions for problems before they arise
• A 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
• Resilient and able to work well under pressure, in a demanding, fast paced entrepreneurial environment
• Keep current on professional knowledge, industry and regulatory trends

Benefits

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.