Scientist II, Formulation Development
PTC Therapeutics, Inc.
August 08, 2026
Remote friendly (Bridgewater, NJ)
United States
Other
Scientist II, Formulation Development
ESSENTIAL FUNCTIONS
Primary Duties/Responsibilities:
- Design/develop robust formulations and manufacturing processes for small molecules for preclinical/clinical studies.
- Plan experiments, evaluate data, and coordinate/execute pre-formulation, formulation, and process development studies; identify challenges and propose solutions.
- Conduct pre-formulation/formulation studies (e.g., TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH).
- Work with internal/external partners; transfer formulation/process to external sites and monitor CDMOs to meet timelines.
- Develop safe, viable, robust formulations (pharmaceutically acceptable excipients) enabling delivery of water-insoluble compounds via multiple routes.
- Conduct QbD risk assessments (per target product profiles) and scale-up/optimization using DoE and modeling tools.
- Provide formulation/manufacturing support and support transfers to contract manufacturing organizations.
- Oversee lab instrumentation maintenance/calibration; maintain safe lab conditions and inventory supply.
- Summarize/report results; present study plans/results; author drug product sections for IND/CTA amendments, NDA, and MAA as needed.
- Maintain experimental records; mentor junior staff.
Knowledge/Skills/Abilities Required:
- PhD (2+ yrs) or MS (4+ yrs) or BS (6+ yrs) in pharmaceutical/material science, chemistry, or related field with relevant formulation experience.
- Hands-on liquid/solid dosage formulation and characterization using lab/formulation equipment (e.g., blenders, granulators, roller compactors, tablet presses, coaters, fluid-bed dryers).
- Understanding of physical pharmacy/engineering and scale-up; desirable CMO oversight.
- Microsoft Office; excellent written/verbal communication; independent and collaborative work; analytical/problem-solving; strong planning/time management.
Preferred:
- Oral and parental route formulation experience; physical chemistry/pharmacy knowledge.
- Electronic lab notebook; analytical instrument troubleshooting (e.g., HPLC, DSC, microscopy, Karl Fisher, X-ray diffractometer, hot stage microscopy, TGA).
- Working knowledge of US/international CMC regs (GMP, 21 CFR, ICH).
Travel: 0–10%
Base salary range: $133,100–$158,000. Eligible for short- and long-term incentives; medical, dental, vision, and retirement savings plans.
ESSENTIAL FUNCTIONS
Primary Duties/Responsibilities:
- Design/develop robust formulations and manufacturing processes for small molecules for preclinical/clinical studies.
- Plan experiments, evaluate data, and coordinate/execute pre-formulation, formulation, and process development studies; identify challenges and propose solutions.
- Conduct pre-formulation/formulation studies (e.g., TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH).
- Work with internal/external partners; transfer formulation/process to external sites and monitor CDMOs to meet timelines.
- Develop safe, viable, robust formulations (pharmaceutically acceptable excipients) enabling delivery of water-insoluble compounds via multiple routes.
- Conduct QbD risk assessments (per target product profiles) and scale-up/optimization using DoE and modeling tools.
- Provide formulation/manufacturing support and support transfers to contract manufacturing organizations.
- Oversee lab instrumentation maintenance/calibration; maintain safe lab conditions and inventory supply.
- Summarize/report results; present study plans/results; author drug product sections for IND/CTA amendments, NDA, and MAA as needed.
- Maintain experimental records; mentor junior staff.
Knowledge/Skills/Abilities Required:
- PhD (2+ yrs) or MS (4+ yrs) or BS (6+ yrs) in pharmaceutical/material science, chemistry, or related field with relevant formulation experience.
- Hands-on liquid/solid dosage formulation and characterization using lab/formulation equipment (e.g., blenders, granulators, roller compactors, tablet presses, coaters, fluid-bed dryers).
- Understanding of physical pharmacy/engineering and scale-up; desirable CMO oversight.
- Microsoft Office; excellent written/verbal communication; independent and collaborative work; analytical/problem-solving; strong planning/time management.
Preferred:
- Oral and parental route formulation experience; physical chemistry/pharmacy knowledge.
- Electronic lab notebook; analytical instrument troubleshooting (e.g., HPLC, DSC, microscopy, Karl Fisher, X-ray diffractometer, hot stage microscopy, TGA).
- Working knowledge of US/international CMC regs (GMP, 21 CFR, ICH).
Travel: 0–10%
Base salary range: $133,100–$158,000. Eligible for short- and long-term incentives; medical, dental, vision, and retirement savings plans.