Research Scientist, Analytical Development - Innovative Gene Therapies
Reporting to: Vice President, Analytical Operations
Location: Menlo Park, CA
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
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
- Other activities as may be assigned
EDUCATION & SKILLS REQUIREMENTS:
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
- Must demonstrate 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
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 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.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to RECRUITERS: 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.