Director/Senior Director, Drug Product Development

Kalaris Therapeutics, Inc.; Berkeley Heights (NJ); Hybrid; USD 180,000 - 270,000; Full time

Job summary

Kalaris Therapeutics, Inc. in Berkeley Heights, NJ, seeks a Director/Senior Director, Drug Product Development to lead strategic and technical development of an intravitreal Fc-fusion biologic from Phase 3 through commercial launch.

This role oversees formulation development, DP process development, analytical characterization, container closure, technology transfer, and manufacturing readiness for vial and prefilled syringe formats.

Qualifications

• PhD, MS, or BS in Pharmaceutical Sciences, Engineering, Biochemistry, or related field.
• 12+ years biotechnology or pharmaceutical industry experience.
• 8+ years leadership experience.
• Intravitreal or ophthalmology biologics experience.
• Expertise in sterile injectable biologics development and commercial manufacturing.
• Experience with Fc fusion proteins or monoclonal antibodies.
• Experience establishing high-concentration protein formulations and partnering with Downstream PD to successfully implement.
• Proven success managing vial to pre-filled syringe conversions.
• Experience supporting Phase 2 through commercial launch.
• Strong understanding of biologics formulation, fill-finish operations, and required drug product process development requirements.
• Experience with CDMO management and technology transfer.
• Experience with Pivotal to commercial vial and syringe development.
• Experience overseeing structural protein analyses and leveraging formulation chemistry.
• A growth mindset.
• Strong executive level leadership.
• Proactive communication and collaboration skills.

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 technical transfers to ensure successful transition of activities to Manufacturing operations and enable GMP production.
• Support IND/BLA regulatory submissions and commercial launch readiness.
• Drive cross-functional execution across Analytical, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain teams.
• Provide executive updates and mentor scientific staff.
• Characterization focus: Subvisible particle assessment, Forced degradation, Stability-indicating analytical strategies, Container closure compatibility, Comparability assessments, Commercial stability strategy development.

Education

PhD, MS, or BS in Pharmaceutical Sciences, Engineering, Biochemistry, or related field

Job description

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 at Genentech. TH103 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 technical transfers to ensure successful transition of activities to Manufacturing operations and enable GMP production.
• Support IND/BLA regulatory submissions and commercial launch readiness
• Drive cross-functional execution across Analytical, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain teams
• Provide executive updates and mentor scientific staff
• Characterization focus:
• Subvisible particle assessment
• Forced degradation
• Stability-indicating analytical strategies
• Container closure compatibility
• Comparability assessments
• Commercial stability strategy development

Qualifications

• PhD, MS, or BS in Pharmaceutical Sciences, Engineering, Biochemistry, or related field
• 12+ years biotechnology or pharmaceutical industry experience
• 8+ years leadership experience
• Intravitreal or ophthalmology biologics experience
• Expertise in sterile injectable biologics development and commercial manufacturing
• Experience with Fc fusion proteins or monoclonal antibodies
• Experience establishing high-concentration protein formulations and partnering with Downstream PD to successfully implement
• Proven success managing vial to pre-filled syringe conversions.
• Experience supporting Phase 2 through commercial launch
• Strong understanding of biologics formulation, fill-finish operations, and required drug product process development requirements.
• Experience with CDMO management and technology transfer
• Experience with Pivotal to commercial vial and syringe development
• Experience overseeing structural protein analyses and leveraging formulation chemistry
• A growth mindset
• Strong executive level leadership
• Proactive communication and collaboration skills

This role is hybrid and will require travel to external vendors as needed to manage vendor relationships and to provide technical oversight. This role requires multiple overnight days of monthly travel to on site meetings in Berkeley Heights, NJ for analytical & formulation, CMC, and company meetings. The travel time is expected to be approximately 25% of the total working hours.

The salary range for this position is $180,000 USD to $270,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.