Research Associate II, Process Development
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 a Research Associate II, Process Development opportunity at their facility in Seattle, WA.
The primary purpose of the Research Associate II for Process Development is to execute experiments to improve clinical-grade, gene-editing processes of Universal Donor Cells and to provide data for CMC documents. This Research Associate II role will work as part of a team evaluating processes, and planning/executing experiments to evaluate all aspects of culturing, gene-editing, and processing of pluripotent stem cells. This position will be provided training to perform all required fundamental skills. 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 using aseptic cell culture technique in both a research and a controlled manufacturing environment.
* Assists with the design and execution of complex laboratory experiments to evaluate processes and products.
* Stays cross-trained on batch record documentation and protocols, and support the clinical gene editing as well as other departments with the maintenance of pluripotent stem cell cultures.
* Collaborate with the clinical gene editing team to identify and troubleshoot challenges in manufacturing processes.
* Demonstrates understanding and ability to record data using Good Documentation Practices.
* 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.
* Collaborates to establish and tech transfer new manufacturing processes and assays.
* Keeps detailed record-keeping and demonstrates ability to write and follow established SOPs.
* 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 cell culture lab, assisting junior members as needed.
* Performs other duties as assigned or special projects as needed.
* The Research Associate 2 will be trained to have complete competency in laboratory environment, with full team integration within 6 months. Once trained, they will move into a shifted schedule to support cell culture and data analysis activities for all process development projects.
* The Research Associate 2 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 the Director of Process Development 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 3+ years of highly relevant laboratory experience.
* Solid years of working knowledge of aseptic mammalian cell culture technique and GDP.
* Experience with method and assay development.
* Ability to troubleshoot and think critically, with scientific attention to detail.
* Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment.
* Ability to adapt and contribute with evolving priorities.
* Strong organizational, time management, and problem-solving skills 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.
* Flexibility to work shifted schedule with at least one weekend day.
* Industry experience with cell culture processes and cell-based assay development strongly preferred.
* Experience with pluripotent stem cell culturing is preferred.
* Experience with gene editing of pluripotent stem cells is preferred.
* Experience working in a GMP environment is highly preferred.
* 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
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Princeton, New Jersey
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