Scientist II, Clinical Bioanalysis

Scientist II

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & 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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency.  We are outcome focused and consistently take accountability for our personal contribution.

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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