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Astellas Pharma Documentation Manager, Analytical Method Development in Seattle, Washington

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 Documentation Manager, Analytical Method Development opportunity at their facility in Seattle, WA .

Purpose:

The primary purpose of the Documentation Manager, Analytical Method Development, is to manage and coordinate the optimization, qualification, execution, and documentation of analytical methods to enable in-process and characterization testing.

Essential Job Responsibilities:

  • Leads documentation efforts for in-house activities, including management of in-process and characterization testing of gene edited pluripotent stem cells, plasmids, and recombinant Adeno-Associated Virus.

  • Tracks various aspects of the execution of analytical methods, sample transfers, characterization, investigations, assay set-up/running/analysis while collaborating with QA, QC, and Operations teams.

  • Works closely with QA teams to author/review/revise analytical method and sample transfer Standard Operating Procedures (SOPs).

  • Works closely with project managers to coordinate the transfer of samples, running of assays and transmission of results.

  • Participates in documentation of method qualifications and method transfers within and outside of Universal Cells.

  • Interacts with contract test laboratories (CTLs) or research affiliates to support sample testing, data analysis and method transfer as required.

  • Performs other duties as assigned or special projects as needed

Quantitative Dimensions:

  • Direct impact on research related to gene editing

Organizational Context:

  • Reports to the Director, Core Technology

  • Collaborates regularly with various teams to track activities document data analysis and interpretation

  • Collaborates regularly with Quality Assurance team

Qualifications:

Required:

  • PhD, MS or BS in Molecular Biology, Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent

  • D. with 3+ years relevant laboratory experience; MS with 7+ years or BS with 10+ years

  • Strong organizational, time management, and problem solving skills with careful attention to detail

  • Experience with analytical method qualification and document creation

  • Familiarity with PCR, qPCR assays, flow cytometry, and other cell based assays

  • Demonstrated technical writing skills

  • Ability to work independently and ability to effectively collaborate with other teams

  • Excellent communication and interpersonal skills

Preferred:

  • Extensive experience with Good Documentation Practices and working within quality system

  • Experience with stem cell biology

  • Experience with gene-editing and cell engineering

  • Experience in the biotech and/or pharmaceutical industry

  • Working knowledge of Southern blotting and Next Generation Sequence analysis

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

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Category Research and Development Research and Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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