Senior Associate, Analytical Quality Control - Innovative Gene Therapy Start Up

Location
Foster City, California
Posted
May 01, 2018
Ref
QC-512018
Required Education
Bachelors Degree
Position Type
Full time

Company Overview:

Orchard Therapeutics is a biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies

Our programmes will use the potential of ex-vivo autologous hematopoietic stem cell gene therapy to restore normal gene function in severe and life-threatening inherited disorders

We work in partnership with the world's leading research centers to harness the life-giving potential of gene therapy

Our mission is to transform the lives of patients with rare disorders through innovative gene therapies

Our vision is to become the leader in gene therapy for primary immune deficiencies and inherited metabolic disorders

Role Description

This an exciting opportunity for a talented QC professional 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 a Senior QC 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.

Responsibilities

  • 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

REQUIREMENTS

Job Requirements

This candidate will possess:

  • Minimum of five 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

Benefits

  • Platinum Healthcare Coverage, Dental and Vision, 401 (k) Safe Harbor Plan, Life Insurance and more including competitive Salary, Bonus and Equity scheme (role dependent).