Talent.com
Associate Director, MSAT, Downstream Drug Substance
Associate Director, MSAT, Downstream Drug SubstanceOtsuka Pharmaceutical • Princeton, NJ, US
Associate Director, MSAT, Downstream Drug Substance

Associate Director, MSAT, Downstream Drug Substance

Otsuka Pharmaceutical • Princeton, NJ, US
1 day 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

    Associate Director Msat Downstream Drug Substance • Princeton, NJ, US

    Related jobs
    Associate Director, Regulatory Affairs CMC

    Associate Director, Regulatory Affairs CMC

    New Jersey Staffing • Princeton, NJ, US
    Full-time
    Acadia Pharmaceuticals Job Opportunity.Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communiti...Show more
    Last updated: 1 day ago • Promoted
    Associate Director, MSAT, Downstream Drug Substance

    Associate Director, MSAT, Downstream Drug Substance

    Otsuka Pharmaceutical Co. • Princeton, NJ, US
    Full-time
    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....Show more
    Last updated: 28 days ago • Promoted
    Associate Director, Drug Product, Manufacturing Sciences and Technology

    Associate Director, Drug Product, Manufacturing Sciences and Technology

    BeiGene • Hopewell, 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 more
    Last updated: 30+ days ago • Promoted
    Global Regulatory Affairs Device Lead (Associate Director)

    Global Regulatory Affairs Device Lead (Associate Director)

    New Jersey Staffing • Morristown, NJ, US
    Full-time
    Global Regulatory Affairs Device Lead.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families.Your s...Show more
    Last updated: 1 day ago • Promoted
    Associate Director, Global Trial Lead

    Associate Director, Global Trial Lead

    Genmab • Princeton, 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 more
    Last updated: 30+ days ago • Promoted
    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 more
    Last updated: 28 days ago • Promoted
    Associate Director / Director of Drug Safety

    Associate Director / Director of Drug Safety

    Systimmune • Princeton, 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 more
    Last updated: 30+ days ago
    Associate Director, Small Molecule Analytical Development

    Associate Director, Small Molecule Analytical Development

    Otsuka Pharmaceutical • Princeton, NJ, United States
    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 more
    Last updated: 1 day ago • Promoted
    Associate Director / Director, Regulatory Affairs -GDP Contractor

    Associate Director / Director, Regulatory Affairs -GDP Contractor

    Shionogi Inc. • Florham Park, NJ, United States
    Full-time
    Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions. Assisting in preparing presentations...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director, Regulatory

    Associate Director, Regulatory

    University of Pennsylvania • Philadelphia, PA, US
    Full-time
    Associate Director, Clinical Research Regulatory.With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within ...Show more
    Last updated: 22 days ago • Promoted
    Associate Director, MSAT, Downstream Drug Substance

    Associate Director, MSAT, Downstream Drug Substance

    Otsuka Pharmaceutical • Princeton, 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 more
    Last updated: 30+ days ago • Promoted
    Associate Medical Director, Rare Hematology

    Associate Medical Director, Rare Hematology

    New Jersey Staffing • Morristown, NJ, US
    Full-time
    Associate Medical Director, Rare Hematology.We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, ...Show more
    Last updated: 1 day ago • Promoted
    Associate Director, Global Regulator Strategy, Neuroscience

    Associate Director, Global Regulator Strategy, Neuroscience

    Bristol Myers Squibb • Princeton, 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 more
    Last updated: 30+ days ago • Promoted
    Associate Director / Director-Global Clinical Pharmacology

    Associate Director / Director-Global Clinical Pharmacology

    HUTCHMED • Florham Park, NJ, US
    Full-time
    Associate Director / Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects. Serves as a team member supporting multiple facets of ...Show more
    Last updated: 30+ days ago • Promoted
    Global Regulatory Affairs Device Lead (Associate Director)

    Global Regulatory Affairs Device Lead (Associate Director)

    Sanofi • Morristown, NJ, US
    Full-time
    Global Regulatory Affairs Device Lead (Associate Director).Location : Morristown, NJ or Cambridge, MA or Framingham, MA.Are you ready to shape the future of medicine? The race is on to speed up drug...Show more
    Last updated: 7 days ago • Promoted
    Associate Director, Global Regulatory Affairs Diagnostics

    Associate Director, Global Regulatory Affairs Diagnostics

    J&J Family of Companies • Raritan, NJ, US
    Full-time
    Job Title : Associate Director, Global Regulatory Affairs Diagnostics.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where c...Show more
    Last updated: 1 day ago • Promoted
    Associate Director / Director, Regulatory Affairs -GDP Contractor

    Associate Director / Director, Regulatory Affairs -GDP Contractor

    Shionogi • Florham Park, NJ, US
    Full-time
    Regulatory Affairs Executive Director.Support the Regulatory Affairs Executive Director in developing and executing regulatory strategies for antiviral programs globally or within specific regions....Show more
    Last updated: 2 days ago • Promoted
    Associate Director, Global Regulatory Affairs, Strategy

    Associate Director, Global Regulatory Affairs, Strategy

    Genmab • Princeton, 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 more
    Last updated: 30+ days ago • Promoted