Stability Specialist, Quality Control
Audentes Therapeutics, Inc.
 South San Francisco, CA

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Audentes is a biotechnology company developing new genetic medicines for rare, life-threatening diseases. We are working urgently to progress our medicines and need additional team members to help us do so. Because our mission is so important, our values are to: Be BOLD: Find a Way, Care Deeply, and Get Stuff Done. If you'd like to be a part of this important mission, please apply to join our team.

About Audentes Therapeutics

Audentes Therapeutics, An Astellas Company, is developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.audentestx.com

Our Values:

  • Be BOLD (Find a Way)
  • Care Deeply – for our patients, each other and our work
  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Audentes Therapeutics is seeking a Stability Specialist to join the Quality Control group. The QC Stability Specialist will be responsible for QC stability program; organization stability studies, management of stability inventory, and stability chambers/equipment, as well as assist with general lab testing. The Specialist will also support sample management and as appropriate, document management and revision. This role will be reporting to the Manager, QC Sample Management and Stability and will be located in our South San Francisco Quality laboratories.

Primary Responsibilities

  • Initiate new stability study configuration documents
  • Update Excel files with all new stability study information, manage Excel files to indicate completion of sample testing
  • Manage stability inventory, stability schedule, pull samples from storage condition(s)
  • Aliquot and label samples, distribute to testing labs, ensure proper storage of samples
  • Ship samples to external contract labs, as required
  • Perform some stability testing as required or commensurate with experience – Color, Clarity, Visible Particulates, pH, Osmolality
  • Interact with Analytical Development, QC Analytical and QC Microbiology teams to ensure timely testing of samples according to protocol
  • Stability data management: collect stability data and create/update stability tables using templates, scan data and put in proper folders, review/manage stability logbooks…
  • Submit stability tables to MasterControl or other EDMS for collaboration and approvals
  • Help with trending of stability data and writing stability reports
  • Lead or participate in stability deviations: invalid results, unexpected results, OOS/OOT, lab investigations, and contract lab discrepancies
  • Perform stability document revisions and document management
  • Ensure lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

About you

Must Have/Required

  • BS degree in biological sciences, cell biology, chemistry or related field with 5+ years of laboratory or stability experience in a GMP environment
  • Experience with laboratory or stability deviations, investigations and/or discrepancies
  • Experience with MasterControl or other EDMS
  • Good to 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
  • Must be willing to work second shift, rotating shifts, overtime, weekends and holidays, as required

May Have/Preferred

  • Knowledge of Good Document Practices (GDP)
  • Demonstrated proficiency in Microsoft Office suite

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.