Associate, Manufacturing

Audentes Therapeutics in South San Francisco, CA

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
  • Compensation: $103,730.00 - 157,700.00 / Year*
[1]Associate, 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 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

Reporting to the Manufacturing Supervisor, this role will be a contributing participant on the Manufacturing 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 Associate 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.

Responsibilities
  • 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
  • Available to work various shifts (Day, Swing, Holidays) as directed by the production schedule
  • Assist in the evaluation and incorporation of new technologies
  • Other duties as assigned
  • Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues. Execute corrective measures addressing any issues in a timely manner
  • Ability to contribute to process improvement plans and help drive to completion
  • Firm understanding of GMPs and is able to identify and escalate potential GMP issues
Required Qualifications
  • BS in Science or Engineering or equivalent experience
  • Associate: 1+ years of experience working in a GMP manufacturing environment
  • Associate II: 4+ years of experience working in a GMP manufacturing environment
  • Senior Associate: 5+ years of experience working a GMP manufacturing environment
  • Display understanding of upstream and downstream process theory (i.e. Cell Culture, Harvest, Tangential Flow Filtration, Column Chromatography, Filling) and equipment operation.
  • Strong communicator with ability to work effectively both independently and as part of a team
  • Experience in maintaining detailed records and ability to assist in document revisions
  • Understanding of cGMPS as related to commercial and clinical operations. Assists in identifying and addressing GMP gaps and ensuring cGMP compliance
  • Effective problem-solving skills
  • Strong computer skills including MS Office (Word, Excel)
  • 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
Preferred Qualifications
  • Knowledge of protein purification and technique
  • Experience with bioreactors and harvest operations
  • Experienced in startup of a new facility
  • Understanding of Clinical and Commercial manufacturing concepts
  • 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 uncertainty and changing priorities
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.

[1] Title commensurate with experience

(ref. AAA-26)
Associated topics: bio, bioinformatic, biophysics, bioprocessing, biosynthetic, enzyme, metabolic, msat, neuroscience, therapeutic

* Estimated salary


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