Director​/Senior Director, Drug Product Development

Kalaris Therapeutics is a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs.

Kalaris’ lead asset, TH103, was developed by Lasker Award winner, Dr. Napoleone Ferrara, a pioneer in the field of VEGF research, and the inventor of Lucentis and Avastin during his time 03 is a novel, clinical stage anti-vascular endothelial growth factor (VEGF) drug, specifically engineered to achieve extended intraocular retention with enhanced VEGF inhibition in patients with exudative and/or neovascular retinal diseases.

In head-to-head preclinical studies, TH103 showed more anti-VEGF activity and longer duration of activity compared to aflibercept, the current market-leading anti-VEGF agent. In a Phase 1a single ascending dose trial, TH103 was generally well tolerated and showed a potent anti-VEGF effect on functional and anatomical outcomes at 1-month post-dosing. Single dose durability signals, including pharmacokinetic analysis and retreatment results, suggest that TH103 may offer extended treatment durability outcomes after a standard four-dose loading regimen.

Kalaris is currently enrolling a Phase 1b/2 Multiple Ascending Dose trial of TH103 in patients with nAMD, to help assess the safety and efficacy of repeat TH103 administration and to inform dose selection for potential Phase 3 development.

Kalaris’ board of directors, management team and investors include co-founders, scientists and leaders and investors from companies that have played pivotal roles in developing retina therapeutics.

About nAMD

nAMD is a leading cause of blindness in the United States and Europe that affected an estimated 1.6 million adults in the United States in 2024. Over the past 20 years, anti-VEGF therapeutics have revolutionized the treatment of prevalent exudative and/or neovascular retinal diseases, which represented an estimated $15 billion global branded market in 2024. While clinical trials for these drugs have shown improvements in mean visual acuity, these results often are not reproduced in real-world settings.

Many patients find the treatment burden to be challenging because it requires a demanding schedule of clinic visits and years of monitoring and treatments. This onerous treatment burden can lead to a lack of adherence to the frequent visit regimen and a decline in vision after initial gains.

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Kalaris is seeking an Director/Senior Director, Drug Product Development. The Director/Senior Director, Drug Product Development will provide strategic and technical leadership for development and commercialization of an intravitreal Fc-fusion biologic product from Phase 3 clinical development through commercial launch. This leader will oversee formulation development, Drug Product process development, analytical characterization, container closure development, technology transfer, and manufacturing readiness supporting stable vial and prefilled syringe presentations.

The candidate will manage study execution, guide data analysis and interpretation, and synthesize iterative experimentation with line of sight to enabling intellectual property protection.

Job Description and Specific Responsibilities

• Lead formulation development for Phase 2 through commercial vial and prefilled syringe products.
• Lead physical and chemical protein stability optimization, degradation mitigation, and formulation robustness.
• Lead successful pivotal stage transitions to both high concentration formulation and combination device drug product.
• Oversee sterile fill-finish drug product process development and commercial process characterization studies including but not limited to: mixing, freeze-thaw, hold time, filtration.
• Contribute to the definition of the qTPP, CPPs, CQAs, process validation strategies, and commercial control strategies
• Oversee container closure development and selection by overseeing studies including but not limited to: transportation, compatibility, extractable/leachables, in use.
• Define characterization strategies and non-GMP real time, accelerated, and forced degradation stability studies
• Provide CDMO oversight of…