Research Associate II, Clinical Gene Editing
Website Astellas Pharma, Inc.
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Universal Cells, an affiliate of Astellas located in Seattle, WA, is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells to produce cells that avoid rejection and can be used in allogeneic cell therapy treatments to treat all patients that need them.
OUR GOAL – ONE CELL FOR EVERYONE
NO IMMUNE SUPPRESSION. NO DONOR MATCHING. NO REJECTION.
We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. Through our diversity, scientific knowledge, professional rigor and focus on innovation, we are merging our technology with the Astellas drug development expertise to unlock cures to many therapies. Join our team of committed, enthusiastic professionals devoted to making the most effective, life-saving cell therapy products in the world.
Universal Cells (UCI) is announcing three Research Associate II, Clinical Gene Editing opportunities at their facility in Seattle, WA.
The primary purpose of the Research Associate II for Clinical Gene Editing is to support the generation of clinical-grade, gene-edited Universal Donor Cells in a controlled manufacturing environment. This Research Associate II role will work as part of a team planning and executing all aspects of gene-editing and engineering of pluripotent stem cells. Will assist with complex laboratory operations, keep appropriate documentation including lab notebooks, batch documentation and experimental summaries. Will be able to execute protocols with minimal guidance and will have the ability to summarize results independently. May assist in generating content and preparing controlled documents and data summaries. This position will acquire further versatility in routine procedures, technical knowledge, understanding of administrative operations, and general troubleshooting.
Essential Job Responsibilities:
- 75% of the time will be spent in the laboratory environment on specified projects editing pluripotent stem cells using aseptic cell culture technique in a controlled manufacturing environment.
- Assists with the designs, planning and execution of AAV-mediated gene-editing of pluripotent stem cells. Demonstrates understanding and ability to record data using Good Documentation Practices.
- Demonstrates ability to write and follow established SOPs.
- Performs data collection and demonstrates understanding and ability to analyze, interpret, and summarize data for stem cell culture and gene-editing processes.
- Communicates results in both oral and written formats in a timely manner and actively participates in team meetings (including cross-functional team meetings) and presentation preparations.
- Prepares and reviews the work of others, including but not limited to, technical slide decks, reports, Standard Operating Procedures (SOPs) and production batch records.
- Serves as a technical resource for preparation of regulatory filings.
- Collaborates with Process Development to identify and troubleshoot challenges in manufacturing operations, and to transfer new process changes.
- Shows initiative in learning new protocols, relevant equipment, and related software.
- Serves as a subject matter expert on experimental methods and production processes.
- Ensures smooth day-to-day operations of the manufacturing lab, assisting junior members as needed.
- Performs other duties as assigned or special projects as needed.
The Research Associate II will be trained to complete competency in laboratory environment, with full team integration within 6 months. During training, they will move into a shifted schedule to support cell culture and data analysis activities for all cell editing projects.
The Research Associate II is a key Technical Operations position ensuring technical execution, documentation and real-time communication of gene-editing production activities to facilitate advancement of clinical candidates.
This position reports to Director of PD and Clinical Gene Editing.
Operates on a shifted schedule that includes at least one weekend day.
May assist with onboarding, training, and guidance to new team members and to junior RAs.
- An MS with 0-2 years or a BS with 2+ years of highly relevant laboratory experience.
- Solid working knowledge of aseptic mammalian cell culture technique and GDP.
- Strong organizational, time management and the ability to maintain accurate and up-to-date records.
- Ability to troubleshoot and think critically, with scientific attention to detail.
- Ability to work effectively both independently and with other team members.
- Excellent communication and interpersonal skills.
- Excellent work planning, organization, and record keeping.
- Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment.
- Flexibility to work shifted schedule with at least one weekend day.
- Experience working in a GMP environment is highly preferred.
- Experience with pluripotent stem cell culturing.
- Experience with gene editing of pluripotent stem cells.
$64K – $86K (NOTE: Final salary could be more or less, based on experience)
To apply for this job please visit astellascareers.jobs.