Senior/Executive Director, Process and Formulation Development

Liquidia•,

About The Position

The Senior/Executive Director of Process and Formulation Development reports to the VP, CMC R&D and is responsible for leading the development, optimization, and scale-up of pharmaceutical manufacturing processes and drug product formulations through external partners. This role provides strategic and technical leadership in translating laboratory/clinical-scale processes to commercial manufacturing, including oversight of technology transfer activities to contract manufacturing organizations (CMOs) focused on Liquidia’s liposomal treprostinil clinical program. The Senior/Executive Director ensures robust, scalable, and compliant processes through the application of scientific principles, Design of Experiments (DoE), and Quality by Design (QbD) methodologies.

Requirements

Ph.D., M.S., or B.S. in Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific or engineering field.
Demonstrated experience with scaling manufacturing processes and technology transfer to CMOs.
Strong expertise in Design of Experiments (DoE), statistical analysis, process characterization, CPP development, pharmaceutical formulation, and manufacturing scale-up.
Deep understanding of GMP, QbD, and process validation.
Excellent technical writing and report authoring skills.
Proven problem-solving ability, strategic thinking, and cross-functional collaboration.
Strong written and verbal communication skills, with the ability to provide clear, concise status updates to cross-functional stakeholders at all levels.
Minimum 15+ years of experience in pharmaceutical process development and/or formulation development.
Demonstrated competency with Design of Experiments (DoE) software and Quality by Design (QbD) principles applied to pharmaceutical development in line with ICH guidelines.

Nice To Haves

Experience in Lipid Nanoparticle (LNP) or liposomal formulation development is highly preferred.
Proven track record of overseeing external partners in manufacturing process/formulation development for late-stage development of pharmaceutical drug products.

Responsibilities

Lead and provide oversight of external partners in drug product and manufacturing processes from late-stage development through commercialization.
Oversee the design, execution, and interpretation of formulation and process development studies.
Develop and characterize critical process parameters (CPPs) and critical quality attributes (CQAs).
Apply Design of Experiments (DoE) and statistical tools to optimize processes.
Provide technical oversight of outsourced manufacturing operations for a liposomal drug product including mixing, extrusion, filtration, sterile processing, and filling operations.
Evaluate process scalability and troubleshoot manufacturing issues.
Provide technical oversight of technology transfer to CMOs.
Develop and review transfer documentation including batch records and process descriptions.
Partner closely with technical interface with external partners.
Collaborate cross-functionally with, Manufacturing, Program Management, External Manufacturing, Regulatory Affairs, and Quality Assurance to ensure alignment on program timelines, priorities and deliverables.