Associate Director, Quality Control, Biologics

Job Summary

Associate Director, Quality Control, Biologics is responsible for late development stage through commercial biologic products including product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content. Candidate should have extensive experience in late phase Biologics development and commercialization, and foster productive collaborations with internal QA, Quality Control, Clinical Development, and Regulatory teams.

Job Description

• Manage analytical method development, characterization and Quality Control testing of late clinical phase an commercial biologic products at contract testing labs and CDMOs. Develop phase-appropriate methods for drug substance/drug product characterization and release testing, including qualification and validation activities.
• Oversee pharmaceutical stability studies for IND and BLA activities, ensuring compliance with regulatory guidelines and industry standards. Provide subject matter expertise on stability-related topics during internal and external audits, inspections, and regulatory interactions. Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in biopharmaceutical stability studies and comparability programs.
• Develop stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions.
• Work closely with Manufacturing and Development partners in TechOps, as well as external stakeholders, to execute analytical development and Quality Control activities according to program needs.
• Responsible for technical leadership and strategic planning to meet cross functional program goals.
• Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones. Collaborate with CMC teams and demonstrating ability to understand and communicate impact of technical risks on CMC program timelines.
• Review and interpret complex data, communicating clearly to cross functional leadership as appropriate.
• Author technical documents (e.g., methods, protocols, reports, etc.), scientific publications, presentations, and regulatory documents.
• Develop and manage comprehensive budgets for various projects ensuring financial resources are effectively allocated and aligned with strategic objectives.
• Lead the QC function in the strategic selection and evaluation process for third-party vendors, conducting market research, assessing vendor capabilities, and making informed recommendations to department leadership regarding vendor partnerships that align with organizational goals and objectives.

Qualifications

Required

• Advanced degree (MS or PhD) in a relevant discipline (e.g., analytical chemistry, biochemistry or related field)
• 10+ years of analytical development and quality control experience with complex biologics spanning late-stage development and commercial products
• Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, and cell-based bioassays
• Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development
• Excellent communication skills with an ability to collaborate effectively across functional lines
• Ability to work independently and multi-task in a fast-moving organization.
• Strong knowledge of ICH and other regulatory guidelines including Analytical Quality by Design.
• Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions.
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders.
• Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment
• Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards.

Preferred

• MS in Analytical Sciences, Biochemistry, or related field with a minimum of 12 years of experience in the biopharmaceutical industry
• PhD in Analytical Sciences, Biochemistry, or related field with a minimum of 7 years of experience in the biopharmaceutical industry

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.

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

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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