Scientist IIPurpose & Scope This role combines scientific expertise and project management leadership to oversee bioanalytical activities across clinical development programs, serving as a key liaison between internal teams and external laboratory partners. The scientist supports bioanalytical and biomarker assay strategies, including assay development, validation, and implementation, while managing timelines, risks, and regulatory requirements to ensure successful study execution. By generating high-quality bioanalytical and biomarker data, the role supports clinical study endpoints, pharmacodynamic assessments, regulatory submissions, and critical decision-making throughout the drug development lifecycle.
Role and Responsibilities - Oversee assay development and routine sample preparation, extraction, and analysis using ELISA, PCR, Sequencing, Flow Cytometry, ELISpot, IHC or other platforms.
- Follow validated methods and standard operating procedures with strong attention to detail under the principles of Good Laboratory Practices (GLP) or GCLP-like regulations.
- Serve as the primary contact for CRO bioanalytical activities, including method transfer, troubleshooting, and data review.
- Oversee method validation/qualification activities.
- Collaborate with Astellas team members and CROs to ensure timely completion of study deliverables within timelines and budgets.
- Responsible for clinical bioanalysis related regulatory submission activities.
Required Qualifications - Advanced Degree in Chemistry, Biochemistry, Analytical Chemistry, or related field.
- PhD with 0-2 years' experience, MS with 3+ years' experience, BS with 5+ years' experience
- Hands-on experience with analytical instrumentation (academic or industry).
- Familiarity with at least one of the following: PCR, Sequencing, Flow Cytometry, ELISpot, IHC, or related platform in biomarker drug development.
- Strong organizational skills and willingness to learn new techniques.
Preferred Qualifications - Demonstrated experience overseeing and managing work conducted at external vendor laboratories, ensuring assay performance, data quality, regulatory compliance, and on-time delivery of bioanalytical results to support clinical development objectives.
- Proven project management experience ensuring the successful delivery of high-quality results that support clinical development milestones.
Location and Working Environment- Remote work from anywhere in the US is available.
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. This role is remote.
Salary Range$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
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
- Company fleet vehicle for eligible positions
- Referral bonus program
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