Sr. Research Associate, 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 Sr. Research Associate, Process Development opportunity at their facility in Seattle, WA .
The primary purpose of the Process Development Senior Research Associate is to work as part of a team planning/executing experiments to evaluate all aspects of culturing, gene-editing, and characterization processes of pluripotent stem cells. This Senior Research Associate will play a key role in the development of programs and assays to support the generation of clinical-grade, gene-edited Universal Donor Cells. This position will also be cross-trained in Good Manufacturing Practices and Good Documentation Practices and will support the Cell Editing Production and Process Development Editing team as needed.
Essential Job Responsibilities:
Designs and executes complex laboratory experiments to evaluate processes and products. 70% of the time will be spent in the laboratory environment on specified projects editing pluripotent stem cells or improving processes using aseptic cell culture technique.
Performs data collection, analysis, and interpretation with a high degree of scientific rigor. Communicates results in both oral and written formats by participating regularly in team meeting preparations and presentations.
Establishes and maintains programs/databases.
Collaborates with other departments to establish and tech transfer new manufacturing processes and assays.
Prepares and reviews the work of others to include, but not limited to, technical slide decks, reports, Standard Operating Procedures (SOPs) and Production batch records.
Supports the Process Development team as well as other departments with the maintenance of pluripotent stem cell cultures.
Supports the Cell Editing Production team to identify and troubleshoot challenges in manufacturing processes. Serves as a subject matter expert on experimental methods and Production processes.
Remains cross-trained on new batch documentation and protocols to support the Cell Editing Production team as needed.
Serves as a technical resource for preparation of regulatory filings.
Performs detailed record-keeping and communicates data analysis in a timely manner.
Ensures smooth day-to-day operations of the cell culture lab.
Performs other duties as assigned or special projects as needed.
- The Senior Research Associate will have trained to complete competency, with full team integration within 3 months. This is a key Technical Operations position ensuring technical execution, documentation, and real-time communication of Process Development activities to facilitate advancement of clinical candidates.
This position reports to the Director of Process Development and Cell Editing.
Will have Lead responsibilities for Process Development team members.
Will assist with onboarding and training of Process Development team members.
Closely collaborates with colleagues within Technical Operations and other departments at Universal Cells and other Astellas sites.
Operates on a Sunday-Thursday or Tuesday-Saturday schedule.
An MS with 2+ years or a BS with 5+ years of highly relevant experience.
Solid technical background in aseptic mammalian cell culture and process optimization.
Ability to identify opportunities for process improvement and to problem solve in a timely manner.
Strong work ethic and adaptability with a passion for working in a fast-paced, dynamic, and diverse work environment.
Strong organizational, time management, and problem-solving skills with scientific attention to detail.
Ability to work effectively both independently and in collaboration with other teams.
Excellent communication and interpersonal skills.
Excellent record keeping.
Experience building and managing databases.
Ability to write and follow established SOPs.
Willingness to learn new protocols, relevant equipment, and related software.
This role will be on a shifted schedule, either Tuesday to Saturday OR Sunday to Thursday.
Experience with culturing, editing, and/or differentiation of pluripotent stem cells.
Experience with scale-up, fill-finish, and cryopreservation processes in cell therapy manufacturing.
Experience with method and cellular assay development.
Familiarity with Good Documentation Practices and working within Quality Systems.
Experience initiating/managing/leading projects.
Experience in leading a team and mentoring/training junior researchers.
Experience with technical writing.
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 Research and Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans