Director, Drug Product

Protego Biopharma, Inc.; San Diego (CA); Hybrid; USD 215,000 - 260,000; Full time

Benefits offered by this job

Stock options

Bonus program

401(k) with employer contribution

Comprehensive health insurance

Relocation assistance

Job summary

Protego Biopharma, Inc. is seeking a Director, Drug Product Development to lead formulation development, drug product process development, and manufacturing for an AL amyloidosis program advancing to registrational Phase 3.

Reporting to the Head of CMC, this role serves as the drug product SME and technical lead for external partners. You will drive oral solid dosage strategy from scale-up to commercial readiness, manage CDMOs, ensure cGMP compliance, and author drug product sections of

Qualifications

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related field with 10+ years of industry experience.
• Deep expertise in small molecule oral solid dosage form development, including formulation design and GMP manufacturing support.
• Experience advancing drug product through late-stage development to registration and commercialization.
• Strong track record managing CDMOs and external manufacturing partners in outsourced settings.
• Knowledge of cGMP, FDA, EMA and ICH; experience authoring CMC content for CTD Module 3 and health authority responses.
• Ability to interpret data and influence cross-functional teams under aggressive timelines.

Responsibilities

• Own the drug product strategy for oral solid dosage products from late-stage development through registration and lifecycle management.
• Lead formulation and manufacturing process optimization for oral solid dosage forms, including excipient selection and dissolution performance.
• Oversee scale-up, tech transfer, engineering and registration batches, validation, and PPQ readiness.
• Establish and maintain drug product quality target attributes, materials attributes, and process parameters using quality by design.
• Select and govern CDMOs and external partners with clear expectations, budgets, timelines, and CAPA resolution.
• Own stability, shelf life, container closure, and primary packaging strategy; align with QA, Regulatory and Supply plans.
• Prepare and review regulatory submissions (IND, IMPD, NDA/MAA) and support health authority inspections.
• Collaborate with Drug Substance and Analytical Development to translate material attributes into development decisions.

Skills

Pharma formulation leadership

Late-stage development

CDMO management

Regulatory strategy (CMC)

Cross-functional leadership

Risk-based decision making

Education

Ph.D. in Pharmaceutics or related field

M.S. with 12+ years experience

B.S. with 15+ years experience

Job description

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.

About the job

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.

Primary Responsibilities

• 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.

Required Qualifications

• 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, registration batches, and commercial readiness.
• Strong track record managing CDMOs and external manufacturing partners in an outsourced biotechnology or pharmaceutical operating model.
• Strong working knowledge of cGMP, FDA, EMA, and ICH expectations, with experience authoring and reviewing high-quality CMC regulatory content, particularly CTD Module 3 drug product sections and health authority responses.
• Demonstrated ability to interpret formulation, manufacturing, analytical, and stability data, make practical risk-based decisions under aggressive timelines, and influence cross functional teams and external partners without direct authority.

Preferred Qualifications

• Experience with a successful NDA or MAA filing, preapproval inspection, product launch, or commercial manufacturing transfer for an oral small molecule product.
• Experience supporting rare disease programs or other settings that require rapid, phase appropriate decisions and close integration of clinical, regulatory, quality, and supply priorities.
• Experience with technically challenging oral formulations, biopharmaceutics, dissolution strategy, formulation enabling technologies, or building drug product systems in a growing biotechnology company is desirable.

Compensation:

$215,000 to $260,000 a year

In addition to a competitive base salary of $215,000 to $260,000, we offer stock options and a target bonus, plus a comprehensive benefits package for employees and their families, including medical, dental, vision, and supplemental disability insurance. Relocation assistance may be available. The salary range is a guideline; total compensation will vary based on qualifications, skill level, competencies, and internal equity.

Job Type:

Full time

Annual bonus program; incentive stock option plan; 401(k) plan with employer contribution; comprehensive medical, dental, and vision insurance; HSA, FSA, and supplemental insurance plans; Paid Time Off; Company Paid Holidays.

Schedule and Work Location

Monday to Friday. United States work authorization required. Hybrid work is preferred, with regular presence in the San Diego office. Ability to travel up to 25 percent for CDMO visits, manufacturing support, technical meetings, or other business needs.

Equal Opportunity Employer

Protego Biopharma is an equal opportunity employer committed to a work environment free of harassment, discrimination, and retaliation. AI tools may assist parts of the recruiting process, but final hiring decisions are made by humans. Contact us for more information on how your data is processed.