Scientist, Analytical Operations - AOQC5
Menlo Park, California, United States
Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare disease through innovative gene therapies.
Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion-dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.
The Scientist, Analytical Operations will execute activities associated with the development and validation of analytical methods in support of clinical development and commercialization of Orchard Therapeutics innovative gene-modified cell-based therapeutic products.
- Manage and conduct testing of 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.
- Developing and implementing data analyses, data collection systems and other strategies that optimize statistical efficiency and quality.
- Interpreting data, analyzing results using statistical techniques and write technical report.
- 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.
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, Protein Chemistry or relevant field plus minimum of 3 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, 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