Remote Director Formulation Development Jobs (NOW HIRING)

About Leona:

LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to thedevelopment of novel therapeutics for high unmet medical needs, including amyotrophic lateral sclerosis (ALS) and treatment-resistant metastatic breast cancer, with the goal of improving patients lives. Our lead drug candidates,lasofoxifeneand ATH-1105, are novel, small molecule therapies with the potentialto address devastating diseases where current treatment options are limited or ineffective. With a strong commitment to scientific excellence and patient-centered innovation, we are dedicated to developing meaningful new therapies for those who need them most.

About this role:

LeonaBiois seeking an experienced Senior Director, Pharmaceutical Development to provide strategic and technical leadership for late-stage oralsolidand oral liquid dosageform development activities across our portfolio. This individual contributor role will serve as a senior leader within the CMC organization, shaping development strategy and driving execution to advance development and commercial readiness. The ideal candidate brings deep formulation and process developmentexpertise,significant experienceworking across US and EU regulatory environments, and a strongtrack recordof leading complex programs through CDMOs and other external partners. This is an opportunity to make a meaningful impactina dynamic biotech environment while helping define long-term developmentstrategy, influence cross-functional decision-making, and build capabilities for future growth.

Responsibilities:

• Lead the strategic direction for late-stage oralsolid and oral liquiddosage form development across the portfolio, with direct accountability for process and product development activities.

• Serve as a senior technical leader within the CMC organization, providing subject matterexpertiseand influencing development, manufacturing, and commercialization strategy across programs.

• Oversee complex workstreams, timelines, technical deliverables, budgets, and risk mitigation plans through CDMOs and other external partners to support development, scale-up, validation, and commercial readiness.

• Lead authoring, review, and strategic input for CMC regulatory documentation, including Module 3.2.P sections, in support of global submissions, responses, and lifecycle management activities in the US and EU.

• Partner cross-functionally with analytical, quality, regulatory, supply chain, and project management stakeholders to define integrated development strategies, apply Quality by Design principles, andestablishrobust control strategies to support development and commercialization.

• Provide senior oversight of manufacturing performance, batch documentation, technical reports, deviations, and change controls, ensuring sound scientific assessment of process data, risks, and operational decisions.

• Drive technology transfer, process validation, and commercial launch readiness activities for oral solid dosage products, including escalation management and executive-level communication when needed.

• Contribute to organizational capability building by mentoring colleagues, shaping best practices, and helping scale the Pharmaceutical Development function in support of company growth.

• Travel as needed to CDMO network sites on the East Coast of the United States to support Person-in-Plant activities, technical reviews, and key development or manufacturing milestones.

Required Qualifications:

• Bachelors, Masters, or PhD in Chemical Engineering, Physical Pharmacy, Pharmaceutics, oranotherscientific discipline with direct formulation development experience.

• Extensive industry experience in pharmaceutical development, including substantial leadership responsibility in late-stage oral solidand oral liquiddose development and commercialization.

• Substantial hands-onexpertisein oral dosage form manufacturing and process development, including oral solid dose (e.g., roller compaction, tableting, coating) and/or oral liquid formulation and processing

• Demonstrated experience working within US and EU regulatory frameworks, including leading the authoring and review of CMC documentation and regulatory content withdemonstratedsuccessful NDA submission approvals

• Proven ability to lead complex technical programs independently with strong scientific judgment, strategic thinking, attention to detail, and consistent execution.

• Significant experiencemanaging and influencing work through CDMOs, contract laboratories, or other third-party partners, including oversight of technical quality, deliverables, timelines, and risk resolution.

• Strong written and verbal communication skills, with the ability to clearly present technical issues, recommendations, and risks to cross-functional stakeholders and executive leadership.

• Demonstrated ability to mentor others, influence across functions, and contribute to building organizational capabilities in a growing biotech environment.

• Comfortable working in a remote environment.
• Willing to travel to CDMO network sites on the East Coast of the United States as business needs require.

• Must be authorized to work in the United States; visa sponsorship is not available for this role.

• This role is currently remote; however, candidates should be willing to support a future hybrid work model with on-site presence 23 days per week in the greater Philadelphia area if business needsevolve.

Preferred Qualifications:

• Experience supporting technology transfer, process validation, commercial manufacturing, and post-approval lifecycle management activities.

• Working knowledge of cGMP requirements, deviation investigations, change control, risk management, Quality by Design principles, and control strategy development for late-stage and commercial products.

• Recent experience within the last five years supporting NDA and/or MAA submissions and approvals.

• Demonstrated ability to work independently and excel in a dynamic, fast-paced, evolving environment.

LeonaBiois an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employmenton the basis ofan individuals race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms,conditionsand privileges of employment, including recruitment, hiring, placement, compensation, promotion,disciplineand termination.