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.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:The Precision Medicine and Diagnostics team is dedicated to the co-development of companion diagnostics alongside our drugs, as well as providing diagnostic testing for patient selection and stratification in clinical studies across all phases of development.
As a Diagnostic Laboratory Operations Manager, you will lead central laboratory operations for patient eligibility and biomarker stratification in clinical studies, ensuring compliance with regulatory and quality standards. You will manage vendor relationships, oversee biosample logistics, and collaborate with study teams to deliver high-quality diagnostic testing and data management support.
Essential Job Responsibilities:- Lead operations for central diagnostic laboratory testing, ensuring that assay validation, laboratory accreditation and quality management system requirements are met for specific clinical trials, and assist in implementing corrective actions as needed.
- Collaborate with clinical and diagnostic teams on laboratory vendor assessment, selection, contracting and execution of services.
- Serve as the primary contact for clinical study teams and companion diagnostic partners, managing laboratory vendors to ensure high-quality biospecimen analysis in adherence to contracted testing specifications.
- Oversee logistics of biosamples from trial sites to central laboratories, ensuring sample integrity, traceability, and compliance with timelines.
- Work with clinical study teams and external vendors to develop diagnostic monitoring and communication plans and ensure proper design of electronic case report forms and data transfer specifications.
- Support data management and clinical study teams on central laboratory diagnostic data reconciliation.
- Troubleshoot and resolve issues related to sample collection, processing, testing, storage, and shipment in collaboration with clinical operations, vendors and diagnostic partners.
- Member of Precision Medicine & Dx project teams supporting drug programs and trials
- Reports to Global Head of Precision Medicine and Diagnostics.
- Matrixed relationship to colleagues on Global Development Teams including Precision Medicine & Diagnostic Lead, Alliance Management, Biosample Management, Project Management, Clinical Science, Data Science, Regulatory Affairs and Translational Medicine.
- Manages lab operations for 4-8 trials within 2-4 drug programs based on complexity and extent of Dx activities
Qualifications:Required- BSc with 3+ years or MSc/PhD with 2 years of relevant experience in lab operations and clinical research.
- Technical expertise in biomarker testing methods, including immunohistochemistry, immunofluorescence, and DNA/RNA assays.
- Experience in vendor management, contract negotiation, and human biosample logistics within clinical trials.
- Familiarity with Laboratory Information Management Systems (LIMS).
- Proven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
- Strong collaboration skills with the ability to present findings to both technical and non-technical stakeholders.
Preferred:- Experience of diagnostic test development under Design Control in compliance with FDA Quality System Requirements or other Health Authority (e.g. EU, Japan, China) regulatory requirements.
- FDA IDE, EU IVDR experience for clinical studies.
Salary Range$125K - $170K (NOTE: Final salary could be more or less, based on experience)
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
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