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Principal Research Associate, Cytogenomics

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 .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a **Principal Research Associate, Cytogenomics** opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

This role fills the critical business need of ensuring compliant laboratory methods within the realm of stem cell therapy development, and biologic and gene therapy quality control, while also making significant scientific contributions and advancing laboratory compliance to improve consistency and efficient delivery of results. The position aims to advance the development of stem cell-based therapies, biologics, and gene therapies across multiple therapeutic areas.

Essential Job Responsibilities:

+ **Method Development, Qualification and Validation:** Support the development, qualification, and validation of methods for the analysis of stem cell products, biologics, and gene therapies, ensuring adherence to GMP standards and regulatory requirements.

+ **Documentation Excellence:** Establish and maintain compliant documentation practices for all qualification and validation activities, emphasizing meticulous record-keeping and compliance with regulatory guidelines.

+ **Scientific Contributions:** Make significant scientific contributions to the development of stem cell-based therapies through innovative experimental design, data analysis, and interpretation.

+ **Quality Assurance:** Implement and maintain a flawless approach to Quality Assurance, including regular audits, process improvements, and adherence to industry best practices.

+ **NGS Expertise:** Apply expertise in next-generation sequencing (NGS) to characterize stem cell products and elucidate underlying molecular mechanisms.

+ **Collaborative Research:** Collaborate effectively with cross-functional teams to integrate genomic analyses into broader research initiatives and therapeutic development projects.

+ **Continuous Improvement:** Drive continuous improvement efforts in assay performance, data analysis workflows, and documentation practices to enhance efficiency, accuracy, and regulatory compliance.

+ **Training and Development:** Provide training and mentorship to junior team members on method development and validation, documentation practices, and Quality Assurance principles

+ **Regulatory Compliance:** Ensure all qualification and validation activities comply with relevant regulatory requirements, including FDA and EMA guidelines for cell therapy products

Qualifications

Required:

+ BS with 10+, MS with 6+ or PhD with 1-2 years of laboratory experience.

+ Highly skilled in chromosome brightfield and FISH processing, analysis, and reporting

+ Highly skilled in cytogenetic and molecular biology principles such as microarray and STR Profiling

+ Excellent documentation practices and attention to detail

+ Leadership and mentorship capabilities

+ Strong knowledge of Quality Assurance and regulatory principles

+ Ability to effectively participate in cross functional collaboration and demonstrate excellent verbal and written communication skills

+ Excellent work planning, organization, and record keeping

+ ASCP certification or equivalent

Preferred:

+ Experience with ddPCR and NGS methods and technologies

+ Familiarity with non-conformance, OOS, CAPA, and change control in the TrackWise digital platform

+ Familiarity with Quality Assurance principles and regulatory guidelines for cell therapy products

+ Familiarity with qualification of laboratory equipment

Working Conditions

+ This position is based in Westborough, MA and will require primarily on-site work in a laboratory working environment.

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

\#LI-TD

Category Integrative Science

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans