Associate Director / Director, Pharmaceutical Development

About Leona:

LeonaBio, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company dedicated to the development 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, lasofoxifene and ATH-1105, are novel, small molecule therapies with the potential to 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:

LeonaBio is seeking an experienced Associate Director / Director, Pharmaceutical Development to lead late-stage oral solid dose development activities across our portfolio. This individual contributor role will play a critical part in advancing development and commercial readiness for oral solid dose products, with particular emphasis on roller compaction, tableting, coating, and primary and secondary packaging. The ideal candidate brings deep formulation and process development expertise, strong experience working across US and EU regulatory environments, and a proven ability to independently drive execution through CDMOs and other external partners. This is an opportunity to make a meaningful impact in a dynamic biotech environment while helping shape development strategy, technical execution, and future growth of the function.

Responsibilities:

• Lead late-stage oral solid dose development, with direct responsibility for process and product development activities related to roller compaction, tableting, coating, and primary and secondary packaging.
• Provide technical leadership for formulation and manufacturing activities across internal teams and third-party development and manufacturing partners.
• Manage workplans, timelines, technical deliverables, and issue resolution through CDMOs and other external partners to support development, scale-up, validation, and commercial readiness.
• Author, review, and contribute to CMC regulatory documentation, including Module 3.2.P sections, in support of submissions and lifecycle management activities in the US and EU.
• Collaborate cross-functionally with analytical, quality, regulatory, supply chain, and project management stakeholders to define development strategy, apply Quality by Design principles, and establish an appropriate control strategy to support development and commercialization.
• Monitor manufacturing performance, review batch documentation and technical reports, and ensure accurate, detail-oriented assessment of process data, risks, deviations, and change controls.
• Support technology transfer, process validation, and commercial launch readiness activities for oral solid dosage products.
• Travel as needed to CDMO network sites on the East Coast of the United States to support Person-in-Plant, technical reviews, and key development or manufacturing activities.

Requirements:

• Bachelor’s, Master’s, or PhD in Chemical Engineering, Physical Pharmacy, Pharmaceutics, or another scientific discipline with direct formulation development experience.
• Significant industry experience in pharmaceutical development, including late-stage oral solid dose development, with the level of responsibility and title aligned to overall experience and qualifications.
• Hands-on expertise in oral solid dose manufacturing and process development, specifically roller compaction, tableting, coating, and primary and secondary packaging.
• Demonstrated experience working within US and EU regulatory frameworks, including authoring and reviewing CMC documentation and content.
• Proven ability to independently manage technical programs with strong attention to detail, sound scientific judgment, and consistent follow-through.
• Experience managing work through CDMOs, contract laboratories, or other third-party partners, including oversight of deliverables, timelines, and technical quality.
• Strong written and verbal communication skills, with the ability to clearly present technical issues, recommendations, and risks to cross-functional stakeholders.
• Experience supporting technology transfer, process validation, commercial manufacturing, and post-approval lifecycle activities is strongly preferred.
• 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 is preferred.
• Must be comfortable in a remote environment and 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.
• This role is currently remote; however, candidates should be willing to support a future hybrid work model with on-site presence 2–3 days per week in the greater Philadelphia area if business needs evolve.
• Must be authorized to work in the United States; visa sponsorship is not available for this role.

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s 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, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.