Associate, Manufacturing Plasmid

Company: Audentes Therapeutics, Inc.
Location: South San Francisco
Posted on: June 6, 2021

Job Description:

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene Therapies 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 Astellas Gene Therapies

Astellas Gene Therapies 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 the 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

This role encompasses upstream and downstream areas of both process development and cGMP manufacturing of plasmids for our gene therapy programs. Reporting to the Manufacturing Manager, this role will be a contributing participant on the Plasmid Manufacturing team. The Plasmid Manufacturing Associate will follow defined tasks in the Plasmid Manufacturing department and will effectively contribute to a team that is ultimately responsible for producing plasmid supply. The Plasmid Manufacturing Associate will assist in process development experiments in the Plasmid development labs and will transfer the process to the production suites, where the Manufacturing Associates will make plasmids under GMP. The Plasmid Manufacturing Associate will meet deadlines and be an active participant in issue reporting and resolution. This position will be located in South San Francisco.

Primary Responsibilities

• Perform all GMP 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
• Execute corrective measures addressing any issues in a timely manner
• 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
• Conduct operations in a collaborative, team environment with a positive attitude to accomplish goals
• Available to work various shifts (Day, Swing, Weekend, Holidays) and OT as directed by the production schedule
• Assist with process development experiments following defined experimental plans for non-GMP supply
• Assist in the evaluation and incorporation of new technologies
• Other duties as assigned

About you

Must Have/Required

• Associate's or BS in Science or Engineering or equivalent experience
• Associate I: 1+ years of experience working in a GMP manufacturing environment
• Associate II: 4+ years working in a GMP manufacturing environment
• Senior Associate: 5+ years working a GMP manufacturing environment
• Display understanding of upstream and downstream process theory (i.e. Fermentation, 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
• Demonstrated experience in maintaining detailed records and ability to assist in document revisions
• Understanding of cGMP's as related to commercial and clinical operations. Assists in identifying and addressing GMP gaps and ensuring cGMP compliance
• Knowledge of aseptic technique, cGMP, or FDA regulations
• Strong computer skills including MS Office (Word, Excel, PowerPoint)
• Effective problem solving skills
• Available to work various shifts (Day, Swing, Weekend, Holidays) as directed by the experimental and production schedules
• Ability to support general investigations and CAPA execution
• Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

• Experience in cell culture and/or protein purification
• Experienced in Startup of a new facility
• Technical understanding of a biotech manufacturing facility
• Understanding of Clinical and Commercial manufacturing concepts
• Experience with single-use technologies
• Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders
• 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.

Keywords: Audentes Therapeutics, Inc., South San Francisco , Associate, Manufacturing Plasmid, Other , South San Francisco, California