VP, Manufacturing Site Operations - Innovative Gene Therapies
VP, Manufacturing Site Operations
San Francisco Bay Area
Location: San Francisco Bay Area, CA
Reporting to: Chief Manufacturing Officer
This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.
Orchard Therapeutics, Ltd. (OTL) is looking for an experienced individual at the (Senior) Vice President level to act as head of site operations for the company’s new GMP manufacturing facility to be built in the San Francisco Bay Area, CA.
Reporting to the Chief Manufacturing Officer, this individual will be responsible for the on time, and on budget completion of the construction and commissioning of the new facility. Once commissioned, this individual will manage the day-to-day operation of the site for the clinical and commercial manufacture of the company’s lentiviral vectors and cell-based gene therapy products.
In this role, the individual will matrix with the company’s technical operations, quality, facilities and G&A departments to recruit staff and to build and operate the infrastructure to deliver the company’s products.
- On time and, on budget construction and commissioning of the company’s new GMP manufacturing facility located in the San Francisco Bay Area, CA
- Matrix with the company’s technical operations, quality, facilities and G&A departments to recruit appropriate staff and build the required operational infrastructure to develop, manufacture and deliver the company’s lentiviral vectors and cell-based gene therapy products
- Once commissioned, manage the day-to-day operations of the San Francisco Bay Area site ensuring compliance with applicable international, federal, state and city regulations for product manufacture and distribution, environmental, health & safety and company policies and procedures
- Create, monitor and report budgets, timelines, objectives and deliverables for the site operation
- Implement and maintain best business and operational practices, identifying areas to improve efficiency and reduce costs
- Facilitate problem-solving, contingency planning, and decision-making for the matrixed facilities, CMC, quality and supply chain teams
- Facilitate linkage between OTLs strategic and operational activities
- Other activities as may be assigned
The ideal candidate for this position will have demonstrated senior management level experience of integrated CMC Technical Operations for cell and gene therapy products in the biotech/pharma industry.
Candidate must possess:
- Proven experience of the design, construction, commissioning and operation of facilities for the commercial manufacture of complex biologicals such as cell and gene therapy products
- Proven technical experience of the development, manufacture and delivery of cell and gene therapy products, likely with specific technical expertise in one or more of cell-based product manufacturing, lentiviral vector production or biologics analytical methods
- Solid understanding of biological product development from pre-clinical through to commercial
- Proven track record of matrix management for complex programs
- Ability to as required, travel to domestic and international sites
Education & Skills
- A minimum BSc or equivalent in Biological Sciences, Bioengineering, Chemistry or an associated discipline
- Expert knowledge of US and European regulatory requirements
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
he successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
For further information on this role do not hesitate to email email@example.com
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.