Senior Director, Ophthalmic Drug Product Development

Kalaris Therapeutics, Inc.; Berkeley Heights (NJ); Hybrid; USD 180.000 - 270.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Ausbildung

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

Jobbeschreibung

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.