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Manufacturing Associate, Swing Shift X 3

Expired Job

Audentes Therapeutics, Inc. San Francisco , CA 94118

Posted 2 months ago

Manufacturing Associate, Swing Shift[1]

About Audentes Therapeutics

Audentes Therapeutics (NASDAQ:BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We believe gene therapy technology has tremendous potential as a treatment approach for many genetic diseases. We currently have four programs in development for the treatment of X-Linked Myotubular Myopathy (XLMTM), Crigler-Najjar Syndrome Type 1 (CN Type 1), CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Pompe disease. We are 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.

Job Description

Reporting into the Manufacturing Management team, this role will be a contributing participant on the newly established Manufacturing Swing Shift team at Audentes. The Manufacturing Associate 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 Manufacturing Associate will contribute to the operation of the production process, meet deadlines, and be an active participant in issue reporting and resolution.

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

  • Execute corrective measures addressing any issues in a timely manner

  • Contributes to process improvement plans and help drive to completion

  • Follows GMPs and identifies and escalates potential GMP issues

  • Will work various shifts (e.g., Days, Holidays) ad hoc as needed and as directed by the production schedule

Required Education, Skills and Experience

  • BS in Science or Engineering or equivalent experience in the pharmaceutical or biotech industry and working in a GMP manufacturing environment

  • Strong understanding of Downstream and/or Upstream process theory (e.g., tangential flow filtration, column chromatography, cell culture theory, cell harvest, aseptic technique) and equipment operation

  • Proven experience in maintaining detailed records and ability to assist in document revisions

  • Understanding of cGMPs as related to commercial and clinical operations

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

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

  • Effective problem solving skills

Preferred Skills & Experience

  • Technical understanding of a biotech manufacturing facility

  • Knowledge of cell culture and/or protein purification

  • Experience in startup of a new facility

  • Experience with single-use technologies

  • Ability to support general investigations and CAPA execution

  • Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle changing priorities

[1] Title commensurate with experience


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Manufacturing Associate, Swing Shift X 3

Expired Job

Audentes Therapeutics, Inc.