Talent.com
Associate Director, MSAT, Downstream Drug Substance

Associate Director, MSAT, Downstream Drug Substance

Otsuka Pharmaceutical Co.Princeton, NJ, US
19 hours ago
Job type
  • Full-time
Job description

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

    Create a job alert for this search

    Director Drug Substance • Princeton, NJ, US

    Related jobs
    • Promoted
    Associate Director, MSAT (Advanced Therapies)

    Associate Director, MSAT (Advanced Therapies)

    J&J Family of CompaniesRaritan, NJ, US
    Full-time
    Associate Director, MSAT (Advanced Therapies).Johnson and Johnson Innovative Medicines is recruiting for the Manufacturing Science and Technology organization! We are working to create a world with...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Drug Product, Manufacturing Sciences and Technology

    Associate Director, Drug Product, Manufacturing Sciences and Technology

    BeiGeneHopewell, NJ, US
    Full-time
    Manufacturing Science And Technology (MST) Role.BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we loo...Show moreLast updated: 15 days ago
    • Promoted
    • New!
    Director of Toxicology

    Director of Toxicology

    VirtualVocationsPhiladelphia, Pennsylvania, United States
    Full-time
    A company is looking for a Director, Toxicology to lead drug development efforts from preclinical stages to clinical trials. Key Responsibilities Oversee IND-enabling activities including pre-clin...Show moreLast updated: 18 hours ago
    • Promoted
    Associate Director Biostatistics

    Associate Director Biostatistics

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    East Hanover, New Jersey or Cambridge, MA.Novartis are supported by biostatisticians in 10+ sites around the globe.Biostatisticians transform clinical data into analyses that build the basis for ma...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director of Analytics

    Associate Director of Analytics

    VirtualVocationsElizabeth, New Jersey, United States
    Full-time
    A company is looking for an Associate Director - Analytics, Global Regulatory Affairs.Key Responsibilities Oversee the semantic layer and custom analytics capabilities in alignment with the Globa...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Global Trial Lead

    Associate Director, Global Trial Lead

    GenmabPrinceton, NJ, US
    Full-time
    Associate Director, Global Trial Lead.At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO ant...Show moreLast updated: 30+ days ago
    • Promoted
    • New!
    Associate Director, Small Molecule Analytical Development

    Associate Director, Small Molecule Analytical Development

    Otsuka Pharmaceutical Co.Princeton, NJ, US
    Full-time
    Associate Director, Small Molecule Analytical Development.Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs.Design and lead method ...Show moreLast updated: 19 hours ago
    • Promoted
    Associate Director, PV Case Management - ICSR

    Associate Director, PV Case Management - ICSR

    Daiichi Sankyo, Inc.Bernards, NJ, US
    Full-time
    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address dive...Show moreLast updated: 29 days ago
    • Promoted
    Associate Director, Regulatory Policy

    Associate Director, Regulatory Policy

    Bristol Myers SquibbPrinceton, NJ, US
    Full-time
    Associate Director Regulatory Policy.Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens ever...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, US Medical Affairs Oncology Solid Tumors

    Associate Director, US Medical Affairs Oncology Solid Tumors

    Daiichi Sankyo, Inc.Bernards, NJ, US
    Full-time
    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address dive...Show moreLast updated: 7 days ago
    • Promoted
    Associate Director, Global Oncology Medical Affairs, Medical Analytics

    Associate Director, Global Oncology Medical Affairs, Medical Analytics

    Daiichi Sankyo, Inc.Bernards, NJ, US
    Full-time
    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address dive...Show moreLast updated: 3 days ago
    • Promoted
    Associate Director, MSAT, Downstream Drug Substance

    Associate Director, MSAT, Downstream Drug Substance

    Otsuka PharmaceuticalPrinceton, NJ, US
    Full-time
    Associate Director, MSAT - Downstream.The Associate Director, MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes for the company's ...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Global Regulator Strategy, Neuroscience

    Associate Director, Global Regulator Strategy, Neuroscience

    Bristol Myers SquibbPrinceton, NJ, US
    Full-time
    Associate Director, Global Regulatory Strategy, Neuroscience.Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely inter...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Precision Health Laboratory Partnership Lead

    Associate Director, Precision Health Laboratory Partnership Lead

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    The Precision Health Lab Partnership Lead will lead Precision Health capability-building across all therapeutic areas with Novartis, aimed to advance the effective adoption of Precision Health labo...Show moreLast updated: 21 days ago
    Associate Director of Drug Safety

    Associate Director of Drug Safety

    SystimmunePrinceton, NJ, US
    Full-time
    Quick Apply
    SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its establi...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, BioStatistics

    Associate Director, BioStatistics

    GenmabPlainsboro, NJ, United States
    Full-time +1
    At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives an...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director, Global Access Strategy Integration Oncology

    Associate Director, Global Access Strategy Integration Oncology

    Bristol Myers SquibbPrinceton, NJ, US
    Full-time
    Associate Director Global Access Strategy Integration, Oncology.Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual.Here, uniquely in...Show moreLast updated: 5 days ago
    • Promoted
    Associate Director, Global Regulatory Affairs, Strategy

    Associate Director, Global Regulatory Affairs, Strategy

    GenmabPrinceton, NJ, US
    Full-time
    Associate Director, Global Regulatory Affairs, Strategy.At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-...Show moreLast updated: 30+ days ago