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Bioanalytical Specialist, Translational Research

Princeton, New Jersey

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.

Essential Functions:

•    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.

Requirements:

Education: 
Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Pharmacology or closely related discipline. Masters degree a plus.

Experience: 
•    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.
•    Experience interacting with external vendors or laboratory partners is a plus.

Technical Skills
•    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 

Working Conditions:

Requires up to 5% domestic and international travel

The anticipated salary for this position will be $90,000 to $105,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

  • 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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