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Pilot Plant Associate I

Employer
Astellas Pharma US, Inc.
Location
South San Francisco, California
Start date
Aug 4, 2022
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Job Details

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 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

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

Category Engineering & Facilities

EOE including Disability/Protected Veterans. Flowserve will also not discriminate against an applicant or employee for inquiring about, discussing or disclosing their pay or, in certain circumstances, the pay of their co-workers. Pay Transparency Nondiscrimination Provision

If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access flowservecareers.com as result of your disability. You can request a reasonable accommodation by sending an email to employment@flowserve.com. In order to quickly respond to your request, please use the words "Accommodation Request" as your subject line of your email. For more information, read the Accessibility Process.

Company

Research and Development is at the core of everything we do. It not only drives our work today, but it fosters the work we will do tomorrow, enabling us to develop innovative therapies with the potential to help millions of people. That’s why we’re focused on turning innovative science into value for patients in areas of unmet medical needs where we have expertise and where Astellas believes innovation can help to address some of the most significant of these needs.

To find out more about our Global Research Divisions, please visit our Astellas Research page: Drug Research | Astellas Pharma Inc.

Find Us
Website
Phone
800-695-4321
Location
1 Astellas Way
Northbrook
Illinois
60062
United States
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