Manufacturing Associate, Swing Shift
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.
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
 Title commensurate with experience
Audentes Therapeutics, Inc.