Associate, Upstream Manufacturing

Audentes Therapeutics, Inc. San Francisco , CA 94118

Posted 3 weeks ago

[1]Associate, Upstream Manufacturing

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 by the goal of improving the lives of patients.

Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing for the best talent available.

Listed below is a current opening for which we are seeking smart, driven, experienced, and just plain nice people to join us in realizing Audentes' mission.

The Role

Reporting to the Supervisor, Manufacturing this role will be a contributing participant on the Manufacturing team at Audentes. The Associate, Upstream Manufacturing will follow defined tasks in the Manufacturing department and will effectively contribute to a team that is ultimately responsible for the processes and manufacturing at Audentes. The Associate, Upstream Manufacturing will be present in the production process, meet deadlines and be an active participant in issue reporting and resolution. This position will be located in South San Francisco.

The specific responsibilities of this position include:

  • Perform all manufacturing operations under cGMP/ISO requirements

  • Adhere to valid manufacturing procedures and documentation

  • Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process

  • Maintain a high level of quality and compliance with regards to all aspects of manufacturing

  • Operate production equipment, including inspection, set up, processing, and cleaning

  • Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues

  • Identify and communicate issues to Manufacturing Supervisor and/or other manufacturing support personnel

  • Execute corrective measures addressing any issues in a timely manner

  • Contribute to process improvement plans and implementation of such plans

  • Other duties as assigned

Required Education, Skills and Experience

  • BS in Science or Engineering or equivalent experience

  • Associate I: 1+ years' experience working in a GMP manufacturing environment in upstream operations

  • Associate II: 4+ years' experience working in a GMP manufacturing environment in upstream operations

  • Senior Associate: 5+ years' experience working a GMP manufacturing environment in upstream operations

  • Demonstrated experience in maintaining detailed records

  • Strong communicator with ability to work independently and as part of a team

  • Effective problem solving skills

  • Strong computer skills including MS Office (Word, Excel)

  • Commitment to Audentes values: Be BOLD, Care deeply, #GSD

Preferred Skills and Experience

  • Technical understanding of a biotech manufacturing facility

  • Regulatory knowledge

  • Experience in startup environment

  • Experience with single use technologies such as bioreactors, welders, sealers

[1] Title commensurate with experience

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Associate, Upstream Manufacturing

Audentes Therapeutics, Inc.