Associate Director, Drug Product Development

The Associate Director of Drug Product Development supports the planning and execution of the overall drug product (DP) development strategy from clinical development through commercialization for multi-component biologic drug products, including monoclonal antibodies (mAbs) and synthetic oligonucleotides. This role provides technical expertise and operational oversight for formulation development, formulation and process robustness characterization, GMP manufacturing, process and product characterization, process validation, and commercial readiness while working closely with external CDMOs.

The Associate Director is responsible for planning, supervising, and supporting drug product development activities throughout the product lifecycle and overseeing outsourced development and manufacturing activities in a virtual operating environment. This position ensures high-quality execution, adherence to project timelines, and compliance with regulatory and quality requirements across formulation development, process optimization, robustness characterization, GMP production, technology transfer, process characterization, process validation, and commercial manufacturing.

The successful candidate should possess demonstrated expertise in formulation development for biologics, formulation and process robustness characterization, late-phase process development, process characterization and validation, technology transfer, GMP manufacturing, quality systems, and CMC documentation to support global regulatory submissions. Experience with Design of Experiments (DoE), Quality by Design (QbD), and risk-based process development approaches is highly desirable. This role requires close collaboration with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other cross-functional teams to advance therapeutic candidates from development through commercialization.

Principal Duties and Responsibilities include the following:

Drug Product Formulation Development
- Serve as the technical subject matter expert (SME) for formulation development of multi-component biologic drug products, including monoclonal antibodies (mAbs) and synthetic oligonucleotides, supporting development from clinical through commercial stages.

- Support the planning and execution of the overall drug product development strategy with primary responsibility for formulation development and formulation lifecycle management.

- Supervise CDMO to execute formulation development activities such as formulation optimization, compatibility assessments, and forced degradation studies.

- Supervise CDMO to execute formulation robustness characterization by evaluating formulation design space (DOE), critical formulation parameters, stress conditions, and manufacturability to establish stable, scalable, and commercially viable drug product formulations.

- Develop formulation control strategies based on product knowledge, risk assessments, Quality by Design (QbD) principles, and regulatory expectations.

- Collaborate closely with Drug Substance Development, Analytical Development, Device Development, and Manufacturing teams to ensure formulation compatibility, product performance, manufacturability, and lifecycle management.

Drug Product Process Development and Manufacturing
- Execute process development, scale-up, technology transfer, and GMP manufacturing activities by providing technical leadership and oversight to CDMOs throughout clinical and commercial development.

- Support process optimization, process characterization, process validation, continued process verification (CPV), and lifecycle management through development, review, and execution of protocols, reports, and technical documentation.

- Integrate formulation characteristics, process capability, and critical quality attributes (CQAs) to establish robust manufacturing processes and commercially viable control strategies.

- Supervise and manage CDMOs and C