Scorpion Therapeutics
Director, Drug Substance and Early Development
Scorpion Therapeutics, Waltham, Massachusetts, United States, 02254
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Role Summary Director, Drug Substance and Early Development overseeing early development activities for the clinical-stage biologics pipeline, including monoclonal antibodies and fusion proteins. Responsible for advancing drug substance development strategy, formulation, cell line development, bioreactor scale-up and tech transfer to ensure robust, scalable, and compliant processes for clinical and future manufacturing. Remote work option available for US-based candidates.
Responsibilities
Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing.
Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners.
Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance.
Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements.
Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions.
Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
Evaluate and implement new technologies to enhance upstream development capabilities.
Qualifications
PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or MS with 12+ years.
Proven track record in upstream process development, cell line development, and bioreactor scale-up for biologics is highly preferred.
Hands-on experience with monoclonal antibodies and/or Fc fusion proteins is required.
Strong understanding of formulation development for early-phase biologics.
Experience working with CDMOs and managing outsourced development/manufacturing activities.
Familiarity with regulatory requirements for early- and late-stage biologics development.
Excellent leadership, communication, and project management skills.
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A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary Director, Drug Substance and Early Development overseeing early development activities for the clinical-stage biologics pipeline, including monoclonal antibodies and fusion proteins. Responsible for advancing drug substance development strategy, formulation, cell line development, bioreactor scale-up and tech transfer to ensure robust, scalable, and compliant processes for clinical and future manufacturing. Remote work option available for US-based candidates.
Responsibilities
Lead MSAT activities for monoclonal antibodies and fusion proteins, from early development through clinical manufacturing.
Oversee cell line development, clone selection, and characterization in collaboration with internal teams and external partners.
Design and optimize bioreactor processes (shake flask to pilot scale) to ensure scalability, robustness, and regulatory compliance.
Drive formulation development strategies for early-phase programs, ensuring compatibility with downstream processing and stability requirements.
Collaborate cross-functionally with Analytical Development, Downstream Process Development, Quality, Regulatory, and Clinical Supply teams.
Serve as a technical SME during tech transfer to CDMOs and during regulatory interactions.
Author and review CMC sections of regulatory filings (IND/IMPD/BLA).
Evaluate and implement new technologies to enhance upstream development capabilities.
Qualifications
PhD in Biochemical Engineering, Cell Biology, Biotechnology, or related field with 10+ years of relevant industry experience; or MS with 12+ years.
Proven track record in upstream process development, cell line development, and bioreactor scale-up for biologics is highly preferred.
Hands-on experience with monoclonal antibodies and/or Fc fusion proteins is required.
Strong understanding of formulation development for early-phase biologics.
Experience working with CDMOs and managing outsourced development/manufacturing activities.
Familiarity with regulatory requirements for early- and late-stage biologics development.
Excellent leadership, communication, and project management skills.
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