Director, Drug Product

Protego discovers and develops first in class small molecule therapeutics that reprogram protein folding to treat monogenic protein misfolding diseases, including myopathy, cardiomyopathy, stroke, renal, retinal, and other degenerative diseases and channelopathies. Our approach builds on the pharmacological chaperone strategy pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, in tafamidis for transthyretin amyloidosis.

Protego Biopharma is seeking a Director, Drug Product Development to provide scientific, technical, and operational leadership for formulation development, drug product process development, and manufacturing as our lead AL amyloidosis program advances from proof of concept into a global, registrational Phase 3 program. Reporting to the Head of CMC, this person will serve as the drug product subject matter expert and accountable technical lead for external development and manufacturing partners.

The role will drive oral drug product strategy across scale up, technology transfer, GMP manufacturing, process characterization and validation, stability and packaging, regulatory filings, and commercial readiness. The Director will partner closely with Analytical Development, Drug Substance, Quality Assurance, Regulatory Affairs, Clinical Supply, Clinical Operations, and Project Management to deliver reliable clinical supply while building a manufacturing process and control strategy suitable for registration and future commercialization.

• Own the drug product technical strategy and execution for oral small molecule products from late-stage clinical development through registration, launch readiness, and lifecycle management.
• Lead formulation and manufacturing process optimization for oral solid dosage forms, including excipient selection, blending, granulation where applicable, compression, coating, encapsulation, dissolution performance, manufacturability, and product stability.
• Lead scale up, technology transfer, engineering and registration batches, process characterization, process validation, PPQ readiness, and planning for continued process verification.
• Establish and maintain the drug product quality target product profile, critical quality attributes, critical material attributes, critical process parameters, specifications, control strategy, and risk assessments using quality by design principles.
• Select, qualify, and provide technical governance for CDMOs and other external partners. Set clear technical expectations, timelines, budgets, and deliverables, and lead resolution of manufacturing deviations, investigations, change controls, OOS or OOT events, and CAPA relevant to drug product.
• Own drug product stability, shelf life, container closure, and primary packaging strategy, and ensure technical alignment among manufacturing, packaging, labeling, release, and clinical supply plans.
• Partner with Quality and Supply Chain to ensure timely GMP manufacture and release of clinical drug product and to establish reliable supply strategies that can transition to commercial scale.
• Author and critically review drug product sections of regulatory submissions and responses, including IND, IMPD, CTA, NDA, and MAA content, and support health authority interactions and inspection readiness.
• Partner with Drug Substance and Analytical Development to understand material attributes that can affect drug product manufacturability, performance, stability, and comparability, and translate data into sound development decisions.
• Communicate technical risks, options, and recommendations clearly to CMC leadership and cross functional teams, manage drug product budgets and timelines, and provide technical leadership to employees, consultants, and external partners as the organization grows.

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related discipline with 10 or more years of relevant industry experience; M.S. with 12 or more years or B.S. with 15 or more years of directly relevant experience will also be considered.
• Deep expertise in small molecule oral solid dosage form development, including formulation design, process development, scale up, technology transfer, GMP manufacturing support, and technical troubleshooting.
• Demonstrated experience advancing drug product through late-stage clinical development, including Phase 3 manufacturing readiness, process characterization, validation strategy,…