Associate, Analytical Quality Control
Associate, Analytical Quality Control
Location: Foster City, California
Reporting to: Director, Quality Control
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.
This an exciting opportunity for a 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 to assist in the set-up of a new in-house Analytical Quality Control (QC) laboratory function and to subsequently execute methods for the testing, lot release and characterization of OTLs innovative gene-modified cell-based therapeutic products and pipeline programs.
- Execution and review of release testing of raw materials, process intermediates, ancillary products, drug substances and drug products
- Completion and review of test records/forms, final reports, SOPs and Certificates of Analysis (CoAs)
- Execution and reporting of stability programs for raw materials, ancillary products, drug substances and drug products
- Drafting of SOPs, records/forms and protocols for in-house QC testing
- Support CMO production activities by coordinating testing activities with appropriate external and in-house departments
- Other activities as may be assigned
This candidate will possess:
- Minimum of three years of experience in the biotechnology or pharma industry with a primary focus on the analytical QC testing of complex biologics
- Experience with the validation and implementation 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 a plus
- Experience of the characterization and QC release testing of viral vector-based and/or cell-based products a plus
- 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
- Some domestic and international travel may be required
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
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.
For further information on this role do not hesitate to email email@example.com
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.