Astellas Pharma
Principal Research Associate, Cytogenomics
Astellas Pharma, Westborough, Massachusetts, us, 01581
Principal Research Associate, Cytogenomics
Astellas Institute for Regenerative Medicine (AIRM) invites applications for the Principal Research Associate, Cytogenomics, located in Westborough, MA. This role ensures compliant laboratory methods within stem cell therapy development and makes significant scientific contributions to the development of stem cell-based therapies, biologics, and gene therapies across multiple therapeutic areas. 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
BS with 10+ years, MS with 6+ years 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, and national holidays. 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. EOE
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
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Astellas Institute for Regenerative Medicine (AIRM) invites applications for the Principal Research Associate, Cytogenomics, located in Westborough, MA. This role ensures compliant laboratory methods within stem cell therapy development and makes significant scientific contributions to the development of stem cell-based therapies, biologics, and gene therapies across multiple therapeutic areas. 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
BS with 10+ years, MS with 6+ years 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, and national holidays. 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. EOE
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
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