Research Scientist, Analytical Development - Innovative Gene Therapy
Research Scientist, Analytical Development
Location: Menlo Park, CA
Reporting to: Vice President, Analytical Operations
The Research Scientist/Senior Research Scientist, Analytical Development will execute activities associated with the development and validation of analytical methods in support of clinical development and commercialization of Orchard Therapeutics, Ltd.’s innovative gene-modified cell-based therapeutic products.
- Conduct release and stability testing of raw materials, process intermediates, ancillary products, drug substances and drug products.
- Conduct experiments in support of qualification/validation of analytical procedures, the transfer of such procedures into internal and/or external QC lab(s), and the setting of appropriate release and stability specifications.
- Manage day-to-day activities at contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs), including the review and approval of test records/forms, protocols and reports, deviations/investigations, Standard Operating Procedures (SOPs) and Certificates of Analysis (COAs).
- Draft and review SOPs, records/forms and protocols for transfer to internal and/or external QC lab(s).
- Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis.
- Execute other activities as may be assigned.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
The ideal candidate for this position will have demonstrated in-depth experience with hands-on execution and management of analytical development/QC functions associated with the GMP production and testing of biologic products in an industry setting.
Candidate must possess:
- PhD in Biological Sciences, Bioengineering, Chemistry or relevant field plus minimum of 2 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)
- Experience with the application of analytical techniques routinely used to test biologic products, including FACS, High Content Analysis (HCA), HPLC/UPLC, ELISA, Capillary Electrophoresis CE), DNA sequencing/PCR, and/or cell-based assays
- Demonstrated effective organizational, project management and problem-solving skills
- Excellent oral and written communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
In addition, candidate will possess one or more of the following qualifications:
- Experience with the development and validation of assays used for characterization and QC testing of viral vectors and/or cell-based products
- Experience interfacing 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
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 offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics, Ltd. is an equal opportunity employer.