Evommune is seeking a Director, Drug Product Development to manage formulation, process, and delivery-device development for protein therapeutic programs in our clinical pipeline. The Director, Drug Product Development will be responsible for all aspects of biologics drug product development, including formulation optimization, manufacturing process oversight, and container closure system changes such as vials, prefilled syringes, and autoinjectors, as necessary during the product lifecycle. This individual will accomplish these activities through the management of external development labs and contract manufacturers. 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.
Formulation, Process, and Device Development
- Coordinate phase-appropriate drug product development activities for protein therapeutics, including formulation, process, container closure, and delivery-device considerations.
- 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.
- Contribute to phase-appropriate control strategies, in partnership with CMC leadership, Analytical Development, Quality Assurance, and Regulatory.
- Identify drug product, formulation, device, and manufacturing risks and recommend practical mitigation options.
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.
- Identify and troubleshoot drug product manufacturing, formulation, device, vendor, and process-related issues in partnership with CDMOs and internal stakeholders.
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.
- Identify drug product and device risks and proactively develop mitigation plans
- Forecast drug product manufacturing needs to meet clinical milestones
- Author and review relevant CMC sections for amendments and briefing packages to support regulatory filings in all relevant territories
Budget & Timeline Management
- Partner with other functional leads and project management to ensure drug product timelines are aligned with broader program timelines.
- Be able to provide scenarios for paths forward and an assessment of associated technical risk.
- 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.
- 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.
- Demonstrated experience in development and implementation delivery devices (PFS, autoinjectors, etc.)
- Demonstrated strong knowledge of FDA and ICH CMC requirements for biologics
- Experience with monoclonal antibodies and fusion proteins
- Strong technical judgment and ability to make phase-appropriate recommendations in a lean biotech environment.
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. Salary ranges are determined by role, level and location and additional factors, including job-related skills, experience, and relevant education or training. We offer 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.
Evommune is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
