Evommune

Evommune

Director, Drug Product Development, Biologics

Palo Alto, CA · Director

Sponsorship not specified$220k-$260kDetected 19 days ago
Product ManagementProject ManagementForecastingGMPFDA RegulatoryLeadershipCollaborationPublic Speaking

About the role

  • This individual will accomplish these activities through the management of external development labs and contract manufacturers.

Responsibilities

  • Support development and implementation of delivery devices for clinical stage biologics, including prefilled syringes, autoinjectors, and other combination product presentations as applicable.
  • Drive development of phase-appropriate drug product manufacturing processes, including fill-finish process development, scale-up, technology transfer, and manufacturing readiness.
  • Support development/optimization of formulations that meet clinical and commercial needs, including stability, compatibility, and manufacturability considerations.
  • CDMO and Manufacturing Oversight Participate in external vendor and CDMO screening and selection Ensure technical content/scope of contracts meets program needs Manage external development labs and CDMOs responsible for formulation development, fill-finish process development, scale-up, technology transfer, and GMP manufacturing activities.
  • Provide technical oversight for drug product manufacturing activities, including person-in-plant support as needed.
  • Coordinate with Quality Assurance to ensure cGMP compliance Review and approve key technical documents including batch records, development reports, protocols, stability reports, manufacturing records, deviations, investigations, and change controls.
  • Work with the Executive Director, CMC Biologics to ensure timely access to appropriate resources for drug product-related activities Support vendor planning, budget forecasting, and resource prioritization for drug product development, manufacturing, device, and clinical supply activities.
  • The Position Evommune is seeking a Director, Drug Product Development to manage formulation, process, and delivery-device development for protein therapeutic programs in our clinical pipeline.

Requirements

  • This individual must be able to make phase-appropriate development-related recommendations based on a thorough knowledge of formulation/device fundamental principles, cGMP requirements, and regulatory guidelines.
  • In this role, the ability to operate effectively in a fast-moving, resource-disciplined biotech environment is essential for the successful candidate.
  • Qualifications Degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field.
  • 8+ years of relevant industry experience with PhD, 10+ years with MS, or 12+ years with BS in biologics drug product development, formulation, process development, or CMC technical operations.
  • Demonstrated experience in formulation development and drug product process development Experience with parenteral biologic drug products, including liquid and/or lyophilized formulations.
  • Experience with fill-finish process development, technology transfer, GMP manufacturing, and CDMO oversight.

Compensation

  • $220k-$260k

Benefits

  • Company-sponsored benefits, which include comprehensive health, dental and vision plans, and pet insurance.
  • In addition, we provide a 401(k) plan, ample time off programs, paid parental leave, life insurance, disability insurance and an employee referral bonus program.
  • Compensation The salary range for this position is $220,000-$260,000 and the position may be eligible for performance-based bonuses and/or equity-linked compensation.

Company info

  • Cross-Functional Collaboration Partner cross-functionally with other process and analytical leads as well as QA, Regulatory, and project management to ensure execution of drug product deliverables as part of the larger program.

Equal opportunity

  • equal opportunity employer and will consider all qualified applicants for employment.
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