Director, Analytical Operations - Innovative Gene Therapy Start up
This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.
Orchard Therapeutics, Ltd. (OTL) is looking for an Associate Director/Director, Analytical Operations to manage activities related to the development, validation and implementation of analytical methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products. More specifically, working with OTLs designated Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs) and an in-house team this individual will manage activities to provide analytical support to facilitate the progression of OTLs product pipeline programs.
- Manage the analytical functions associated with the development, GMP production and testing of OTLs products
- Execution, review and approval of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
- Manage activities at CMOs and CTOs for the development, qualification and implementation of analytical methods, including the design, review and approval of protocols, test records/forms, final reports and Standard Operating Procedures (SOPs)
- Manage QC activities at CMOs and CTOs, including the review and approval of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
- Establish and oversee/execute stability programs for raw materials, ancillary products, drug substances and drug products
- Drafting and review of SOPs, records/forms and protocols for in-house QC testing and overall analytical operations
- Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
- Assist in the preparation of CMC regulatory submissions
- Other activities as may be assigned
As a proven technical expert in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry, this candidate will possess:
- Minimum of 10 years of experience in the biotechnology or pharma industry with a primary focus on the development, validation and application of analytical methods for product development, characterization and QC testing
- Experience of the characterization and QC release testing of viral vector-based and/or cell-based products a plus
- Experience with the development, validation and application of analytical techniques in a QC environment, including FACS, High Content Analysis (HCA), ELISA, Capillary Electrophoresis, DNA sequencing, qPCR/PCR, cell culture and cell-based assays
- Experience of managing CMO/CTO relationships and projects
- Sound understanding and demonstrated application of statistical methods/tools
- In-depth knowledge of US and European Pharmacopeia methods and requirements
- In-depth knowledge of FDA, EMA, GMP, WHO and ICH regulatory requirements
The ability to travel domestic and international
Education & skills
- A minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
Creative problem solver
Ability to operate in a fast-paced, multi-disciplinary industrial environment
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.
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