Associate Director, Bioanalysis

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs • Oversee bioanalytical method development, qualification, validation, and sample analysis activities • Conduct scientific troubleshooting and optimization • Develop and maintain partnerships with bioanalytical CROs and external vendors • Monitor vendor performance and adherence to study timelines, quality standards, contractual obligations, and regulatory requirements • Ensure bioanalytical activities comply with global regulatory guidance and industry best practices • Serve as the bioanalytical subject matter expert on cross-functional project teams • Provide scientific recommendations and risk assessments to support decision making • Support regulatory submissions through submission-related documents, agency-question responses, and inspection-readiness activities • Evaluate emerging analytical technologies, biomarker strategies, and innovative measurement approaches • Drive continuous improvement, digital solutions, and operational efficiencies within bioanalysis

🎯 Requirements

• Ph.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or M.S. or B.S. degree with a minimum of 8 years of relevant industry experience • Demonstrated expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays • Strong knowledge of global bioanalytical regulatory guidance and industry standards • Hands-on experience and understanding of LC-MS/MS, ELISA, ECL, flow cytometry, and other relevant platforms • Experience with immunogenicity assays, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, is a plus • Experience managing CROs and external partnerships, including oversight of deliverables, budgets, timelines, quality, and compliance • Strong project management skills with the ability to prioritize and manage multiple complex programs simultaneously • Excellent verbal, written, and presentation skills • Ability to communicate complex scientific information effectively to technical and non-technical stakeholders • Demonstrated ability to work collaboratively in cross-functional teams and influence decision making

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Incentive opportunity