Associate Director, Analytical Operations - AOQC4


Full-time

Menlo Park, California, United States

Analytical Operations

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.

Orchard Therapeutics, Ltd. (OTL) is looking for an Associate Director, Analytical Operations to manage activities related to the development, validation and implementation of 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.


RESPONSIBILITIES:

  • 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.

Requirements

EDUCATION & SKILLS REQUIREMENTS:

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 analytical methods for vector- and cell- based product development characterization and QC testing
  • 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.
  • 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

Benefits

BENEFITS

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 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.