Pilot Plant Associate I

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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: ****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 ****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 Pilot Plant Manager, the Pilot Plant Associate will participate in upstream and downstream areas of AAV development in the Pilot Plant for new gene therapy programs and processes. This position will be located in South San Francisco, CA.
Responsibilities
Perform all operations as directed per internal policies and other requirements.
Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in the process
Maintain a high level of attention to detail with regards to all aspects of manufacturing execution
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
Conduct operations in a collaborative, team environment with a positive attitude to accomplish goals
Available to work outside of normal business hours and/or overtime as required
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
Requirements
Required Qualifications
BS in Science or Engineering or equivalent experience
Associate I: 1 years of experience working in a pharmaceutical/biologics manufacturing environment
Associate II: 4 years working in a pharmaceutical/biologics manufacturing environment
Senior Associate: 5 years working a pharmaceutical/biologics manufacturing environment
Display understanding of upstream and downstream process theory (i.e., Fermentation, Harvest, Tangential Flow Filtration, Column Chromatography) 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
Strong computer skills including MS Office (Word, Excel, PowerPoint)
Effective problem-solving skills
Available to work outside of normal business hours and/or overtime as required
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
Experience in cell culture and/or protein purification
Experienced in Startup of a new facility
Technical understanding of a biotech manufacturing facility
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 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
#LI-LK1
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type
Full-time
Location
CA, South San Francisco
Category
Engineering & Facilities

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