Bioanalytical Specialist, Translational Research
About The Position
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Specialist, Bioanalytical, Translational Research supports multiple pharmaceutical development programs by managing clinical sample use and disposition for biomarker testing, coordinating with external vendors, and providing data analysis support to biomarker teams. This role also facilitates collaboration with project teams and contributes to related clinical trial activities as needed.
Requirements
- Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Pharmacology or closely related discipline. Masters degree a plus.
- Minimum 2 years of experience in bioanalytical, translational research, or clinical research settings, preferably in the pharmaceutical or biotechnology industry.
- Exposure to handling and processing clinical samples, including sample tracking and storage.
- Hands-on experience with biomarker assays, data analysis, or quality control activities.
- Participation in cross-functional project teams or collaborative research initiatives.
- Knowledge of bioanalytical and biomarker assay principles, sample handling, and biobanking processes.
- Familiarity with clinical sample documentation and regulatory requirements (e.g., GCP, SOPs, TMF).
- Proficiency in basic data analysis and reporting using standard software tools (e.g., Excel, GraphPad, or equivalent).
- Strong organizational skills with the ability to track multiple samples, datasets, and projects.
- Effective written and verbal communication skills for scientific documentation and cross-functional collaboration.
- Ability to follow protocols, standard operating procedures, and quality guidelines with attention to detail.
- Familiarity with scientific analytical software (JMP, R, Etc)
- Proficient in MS Office Suite
Nice To Haves
- Masters degree a plus.
- Experience interacting with external vendors or laboratory partners is a plus.
Responsibilities
- Implement and coordinate with other functional areas to institute processes for clinical sample management, from informed consent to data generation, including biobanking processes.
- Support biomarker teams in managing biomarker activities, such as organizing and analysis of biomarker data, conducting biomarker data verification and quality control, etc.
- Assist in coordinating and overseeing vendors for biomarker and bioanalytical assays, including selection, contracting, performance monitoring, and collaboration with colleagues across regions (e.g., Japan) and functions (Clinical Operations, Biometrics, Medical Sciences). Represent Translational Research on study teams.
- Maintain and keep bioanalytical assay and clinical study-related files and documents organized and archived in the trial master file (TMF).
- Ensure regulatory and procedural compliance by following applicable standards, guidelines, and regulations for patient sample handling and biomarker data management.
- Contribute to process improvement and innovation by developing optimized methods for sample handling, data management, and integration of results into the design of new clinical studies.
- Develop and maintain SOPs and related documents (manuals, work instructions) for sample acquisition, handling, and use.
- Collaborate across functions to support departmental and company goals, including contributions to study action plans and broader program objectives.
Benefits
- 401K with company match
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Life & Disability Insurance
- Concierge Services
- Long Term Incentive Program (subject to job level and performance)
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
