at Astellas Pharma in Northbrook, Illinois, United States
Job Description
Principal Scientist – PK, Clinical Bioanalysis Operations
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 .
The Role
Responsible for the regulated bioanalytical assay development, validation, and implementation of bioanalytical methods in the quantification of human biospecimens from clinical studies across multiple therapeutic areas/assets to support decision making.
Work in cross functional capacity to obtain clinical sample results to inform program strategy and clinical trial decisions.
Responsibilities
+ Serve as a subject matter expert for regulated bioanalysis across multiple modalities, regulatory inspections and QA audits.
+ Serve as a bioanalytical lead in asset teams and clinical development for decision making (Go/No-go) from P0 through post marketing obligations.
+ Collaborate with stakeholders providing solutions to challenges and mitigating risk.
+ Manage the bioanalytical assay transfer/validation, quality and conduct at external bioanalytical vendors and ensuring regulatory compliance. Provide technical expertise and guidance over the assay life cycle.
+ Contribute to regulatory submission documentation i.e., INDs, IBs, NDAs/BLAs
+ Ability to collaborate cross functionally within the research organization and clinical development across all regions.
+ Lead the identification and application of new technology assessments and utilization in human clinical trials.
+ Ability to develop, coach and mentor people. Team lead a plus.
+ Keep current with all regulatory guidelines and technical innovations.
+ Follow and influence relevant Standard Operating Procedures and current bioanalytical regulatory guidelines.
Required Qualifications
+ PhD in biochemistry, molecular biology, immunology, or cell biology with minimum 8 years industry experience in biopharma development with a primary focus on the development, validation and implementation of regulated bioanalytical methods supporting clinical development.
+ Working knowledge of bioanalytical method validation and sample analysis regulatory guidelines in all regions (ICH, FDA, EMA, PMDA, )
+ Extensive experience in ligand binding and/or chromatography assays of small molecule, biologics, oncovirus, and AAVs
+ Exposure to work experience in assay validations for biomarkers a plus.
+ Must be able to work under strict or accelerated timelines with ability to provide deliverables.
+ A clear and organized approach to work activities, strong process driven mindset with creative problem solving skills. Great attention to detail and a work ethic to deliver high quality results.
+ Skilled in preparing and presenting scientific presentations.
+ Participate in process improvements and develop best practices for bioanalysis operations.
+ Self-motivated, excellent team player with good communication skills
+ Travel is <30%
+ Other relevant responsibilities as assigned
Preferred Qualifications
+ Experience with mass spectrometric analyses of biologics.
+ Experience with regulatory agencies interactions and inspections
Work Environment
*Position is open to remote working environment with requirement to be onsite as needed for business conferences or meetings.
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.
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
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
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Category Applied Research Management
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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