Associate, Downstream Manufacturing at Astellas in South San Francisco, California

Job Description:

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 an Astellas Center of Excellence 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.astellasgenetherapies.com

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

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 to the Downstream Manufacturing Supervisor, this role will be a contributing participant on the Manufacturing team at Audentes. The Associate, Downstream 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, Downstream Manufacturing 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.

Primary Responsibilities

* Perform all manufacturing operations under cGMP/ISO requirements
* Display understanding of Downstream process theory (i.e. Tangential Flow Filtration, Column Chromatography) and equipment operation
* 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
* 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
* Available to work various shifts (Day, Swing, Holidays) as directed by the production schedule

About you

Must Have/Required

* BS in Science or Engineering or equivalent experience
* Associate: 0-3+ years working in a GMP manufacturing environment in downstream operations
* Associate II: 4-5+ years working in a GMP manufacturing environment in downstream operations
* Senior Associate: 5+ years working a GMP manufacturing environment in downstream operations
* 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
* Strong computer skills including MS Office (Word, Excel)
* Effective problem-solving skills
* 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

May Have/Preferred

* Knowledge of protein purification and technique
* Experienced 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 uncertainty and changing priorities

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