Director, Bioanalysis

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

As a Director of Bioanalysis, you will play a critical role in advancing drug development by overseeing outsourced bioanalytical activities related to clinical studies. You will develop and implement bioanalytical strategies aligned with global development and regulatory requirements, while setting industry best practices and standards for bioanalysis.  The Director of Bioanalysis collaborates with cross-functional teams to ensure efficient implementation and continuous improvement and requires strong leadership, scientific expertise, and strategic thinking. You will report to the Senior Director, Bioanalysis, Genomics & Biomarker Research.

This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. Remote options will be considered for US candidates.

Job Description:

Bioanalytical Operations:

• Manage existing and select new external bioanalytical laboratories, including outsourcing, ensuring conformity with contractual agreements, deliverables and regulatory compliance.
• Oversee scientific processes involved in conducting bioanalysis and fit for purpose development and validation of analytical methods for small molecules, biologics, and other drug modalities.
• Coordinate analytical activities with project teams to meet clinical development timelines.

Scientific Expertise:

• Stay abreast of advancements in bioanalytical techniques, instrumentation, and methodologies and establish processes for incorporation into clinical programs when appropriate.
• Contribute to scientific publications and conferences.

Team Management:

• Manage a team of bioanalytical contributor(s).
• Provide mentorship, guidance, and professional development opportunities.
• Foster a collaborative and innovative work environment.

Regulatory Compliance:

• Ensure compliance with regulatory guidelines (ICH, FDA, EMA, PMDA, etc.) for bioanalytical studies.
• Participate in regulatory submissions, contribute to interactions, and answer agency questions.

Minimum Qualifications:

• Ph.D. in Analytical Chemistry, Biochemistry, or related field.
• Extensive experience (8-10+ years) in bioanalysis within the pharmaceutical or CRO industry.
• Strong knowledge of LC-MS/MS, ligand-binding assays, and other bioanalytical techniques.
• Demonstrated ability to work on multiple complex projects simultaneously with high attention to detail.
• Proficient in global bioanalytical regulations.
• Solid knowledge of bioanalytical data flow in support of clinical trials.
• Proven leadership skills and ability to manage teams effectively.
• Team player with strong organizational, inter-personal, written and communication skills.

Our Benefits:

• Comprehensive medical, dental, vision and prescription drug coverage
• Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance.
• Tuition reimbursement
• 401(k) match
• PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

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Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offering