Analyst, QC I/II/Senior – Temporary

Analyst, QC I/II/Senior - Temporary

About Audentes Therapeutics

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases.  We are leveraging our AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown.  Our product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced and passionate team driven to improve the lives of patients.

Audentes leverages strong, global relationships with the patient, research, and medical communities, and we take pride in carefully selecting our colleagues.  Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us on our journey.

The Role

Audentes Therapeutics is seeking experienced Quality Control professionals with scientific technical expertise in molecular biology and protein chemistry. The Analyst, QC I/II/Senior (Temporary) will be responsible for implementing and executing analytical testing in support of clinical and commercial viral vector products in compliance with GMP requirements. Will also support testing for stability studies, methods validation studies and equipment validation. This role will be in our South San Francisco Quality laboratories.

Responsibilities

  • Author/revise technical reports and laboratory procedures (SOPs and methods)
  • Perform release, stability, and in-process testing in supporting production activities
  • Perform analytical testing in supporting technology transfers
  • Review data and performs analysis and interpretation of test results
  • Participate in method development, transfer and qualification/validation studies
  • Participate in equipment qualification/validation studies
  • Participate in deviation and OOS investigations
  • Perform QC lab support activities including but not limited to sample management, reagent preparation, and instrumentation maintenance and calibration

Required Qualifications

  • BS. degree in Biological Sciences with 0-2+ years of relevant experience or exposure to industry (QC Analyst I requirements) / B.S. degree in Biological Sciences plus 2-5+ years of relevant industry experience or M.S. degree in Biological Sciences plus 0-3+ years of relevant industry experience in quality control role (QC Analyst II requirements) / B.S. degree in Biological Sciences plus 5-8+ years of relevant industry experience or M.S. degree in Biological Sciences plus 3-5+ years of relevant industry experience in quality control role (QC Senior Analyst requirements)
  • Demonstrated experience in molecular/cell biology required (minimum 1 year)
  • Prior laboratory hands-on experience with a variety of analytical techniques including, but not limited to, ddPCR, gel electrophoresis, protein quantification, ELISA
  • Experience analyzing experimental data
  • Good to excellent technical writing skills
  • Must be capable of observing and adhering to lab safety standards and protocols
  • Successfully performs routine work independently with minimal instructions
  • Excellent technical writing skills and verbal communication skills
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
  • Highly self-motivated and goal-oriented
  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
  • There are openings on multiple schedules; flexibility outside of the listed hours is expected
    • First schedule: Wednesday - Saturday, beginning at 9 am
    • Second schedule: Thursday - Sunday, beginning at 9 am
    • Third schedule: Monday - Friday beginning at 9 am
    • Fourth schedule: Monday - Friday, beginning at 12 pm

Preferred Qualifications

  • Prior experience in GMP QC environment (minimum 1 year) is strongly desired
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries is strongly desired
  • Experience with HPLC techniques and/or experience with mammalian cell culture and cell-based assays

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

 

Job Details

Reference # AAA-44
Posted on 13 Feb 2020
Closes on
Location(s) South San Francisco
Department Quality
Career level Entry Level, Experienced (non-management)
Hours/Status Contract
More details (document)
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