Associate II, Manufacturing
Astellas

Job Info

Why Work for Us

Are you ready to use your experience and expertise to make an impact on patients' lives? Audentes 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 Audentes Therapeutics

Audentes Therapeutics, an Astellas Company, 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 their 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

Reporting into the Supervisor, Manufacturing Upstream, this role will be a contributing participant to the upstream operations at Astellas Gene Therapies. The Associate, 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, Manufacturing will be present in the production process, meet deadlines, and be an active participant in issue reporting and resolution.

This position is located in South San Francisco.



Primary Responsibilities


* Upstream operations (cell growth, harvest), equipment operation (bioreactors, incubators, tube welders/sealers), and aseptic processing.
* Performs aseptic work inside a hood.
* Adhere to and perform all documentation to provide the proper accountability and traceability of components used and operations taken.
* Set up equipment/machines for proper operation, including installation of consumables and disassembly of equipment and parts required for upstream operations.
* Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process. Adheres to current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations.
* 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.
* Assists/writes SOPs (Standard Operating Procedures), batch records, and other GMP documentation.
* Records and helps review documents that are required to maintain documentation and compliance with cGMP
* Other duties as assigned.



About you

Must Have/Required


* BS in Science or Engineering or equivalent experience
* Associate: 1+ years of experience working in a GMP manufacturing environment
* Associate II: 2+ years of experience working in a GMP manufacturing environment
* Associate III: 5+ years of experience working in a GMP manufacturing environment
* Senior Associate: 8+ years of experience working a GMP manufacturing environment
* Displays 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
* Experience in maintaining detailed records and ability to assist in document revisions
* Firm understanding of cGMPS 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.
* Effective problem-solving skills
* Strong computer skills including MS Office (Word, Excel)
* Ability to support general investigations and CAPA execution.
* Available to work various shifts (Day, Swing, Holidays) and OT as directed by the production schedule
* 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.
* Must be willing to work second shift, rotating shifts, overtime, weekends and holidays, as required

May Have/Preferred


* Experience in cell culture and/or protein purification.
* 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
* Technical understanding of a biotech manufacturing facility

Benefits:


* Medical, Dental and Vision Insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
* 401(k) match and annual company contribution
* Company paid life insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled