Associate Director, MSAT, Downstream Drug Substance - Otsuka Pharmaceutical Co. : Job Details

Associate Director, MSAT, Downstream Drug Substance page is loadedAssociate Director, MSAT, Downstream Drug SubstanceApply locations Princeton Remote time type Full time posted on Posted 7 Days Ago job requisition id R9769

Job Summary

The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes for the company's biologics portfolio executed at CDMOs . This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management activities conducted by external partners.

• Key Responsibilities:
  • Serve as the primary technical subject matter expert (SME) for downstream processing (chromatography, TFF/UFDF, viral clearance/filtration, etc.).
  • Lead and manage the technical aspects of downstream process technology transfers to CDMOs, including documentation review, gap analysis, and risk assessment.
  • Provide expert technical oversight of downstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls.
  • Lead or significantly contribute to troubleshooting efforts and root cause investigations for downstream process deviations or performance issues at CDMOs.
  • Analyze downstream process data (via CPV program, campaign summaries) to monitor performance, identify trends, and propose process improvements.
  • Support process characterization and validation activities (PPQ) for downstream processes executed at CDMOs.
  • Evaluate and manage the implementation of downstream process changes and improvements post-approval.
  • Author and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing.
  • Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory, Process Development, Analytical Development, and CDMO technical teams.
  • Stay current with advancements in downstream processing technologies, analytics, and regulatory expectations.

• Qualifications:
  • Degree (Ph.D. preferred, MS/BS considered with extensive experience) in Chemical Engineering, Biochemical Engineering, Biochemistry, or related life sciences field.
  • Minimum 8-10+ years of relevant experience in the biopharmaceutical industry with a strong focus on biologics downstream process development, scale-up, technology transfer, and/or manufacturing sciences/support.
  • Significant experience providing technical oversight for biologics downstream processes manufactured at CDMOs is highly desirable.
  • In-depth technical knowledge of purification techniques (various chromatography modes, TFF/UFDF), viral clearance strategies, filtration, and potentially formulation/fill-finish operations.
  • Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH).
  • Familiarity with process validation principles and CPV.
  • Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus).
  • Excellent communication, collaboration, and influencing skills.
  • Ability to work effectively in a fast-paced, virtual environment.

Travel Requirements: Approximately 15-25% travel required (domestic and potentially international) to CDMO sites

CompetenciesAccountability 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 offerings; .

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic .

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request .

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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond —under any circumstances—for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023 .

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.

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