Scientist II, Clinical Bioanalysis
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
