Associate Director, Analytical Operations - AOQC5
Menlo Park, California, United States
Orchard Therapeutics Limited is a global biotechnology company dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.
Orchard Therapeutics, Ltd. (OTL) is looking for an Associate Director, Analytical Operations to manage activities related to the development, validation and implementation of cell-based analytical methods for the testing, lot release, and characterization of OTL’s innovative gene-modified cell-based therapeutic products. More specifically, working with OTL’s designated Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs), this individual will manage analytical activities to facilitate the progression of OTLs product pipeline programs.
- Manage and/or conduct experiments in support of process development, qualification/validation of analytical procedures, and the transfer of such procedures into internal and/or external QC lab(s)
- Manage day-to-day activities at contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs), including development, validation, and implementation of analytical methods, review and approval of test records/forms, protocols and reports, deviations/investigations, and Standard Operating Procedures (SOPs)
- Draft and review SOPs, records/forms, protocols, and reports for transfer to internal and/or external QC lab(s)
- Support in-house process development and CMO production activities by coordinating testing activities with appropriate external and in-house departments
- Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis
- Assist in developing and establishing analytical policy and process to facilitate department operations and development
- Other activities as may be assigned
As a proven technical expert in the development, manufacture and delivery of cell or gene therapy products with significant applied experience in the biotechnology industry, candidate must possess:
- PhD in Biological Sciences, Chemistry or relevant field plus minimum of 15 years of experience in the biotechnology or pharma industry, with a primary focus on analytical development for biologic products (MS/BS with more extensive relevant experience also considered)In-depth knowledge and experience in the biotechnology or pharma industry, with a primary focus on the development, validation and application of cell-based analytical methods for vector- and cell- based product development characterization and QC testing. Expertise in HPLC/UPLC, and LC/MS are a plus
- Demonstrated effective organizational, project management, and problem-solving skills. Must be an effective leader to plan and to direct associates and scientists to achieve deliverables and meet timelines
- Understanding of and familiarity with Lentiviral vector and stem cell process development, characterization, validation, and production is a plus
- Experience with managing CMO/CTL relationships and projects
- Sound understanding and demonstrated application of statistical methods/tools (e.g. SAS, JMP)
- Knowledge of US and European Pharmacopeia methods and requirements
- Knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
- Excellent oral and written communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- This position requires frequent on-site presence at CMOs and contract vendors; therefore, ability to travel is a pre-requisite
- Extensive experience with the application of analytical techniques routinely used to test vector- and cell- based products, including cell-based assays, enzymatic assays, HPLC/UPLC, flow cytometry, ELISA, and DNA sequencing/PCR. Proven expertise and experience in modeling analytical data is a must
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. 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, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
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.