Scientist II, Formulation Development
PTC Therapeutics, Inc.
August 29, 2026
Remote friendly (Bridgewater, NJ)
United States
Clinical Research and Development
Scientist II, Formulation Development
Primary Duties/Responsibilities:
- Design and develop robust formulations and manufacturing processes for small molecule compounds for preclinical and clinical studies.
- Prepare experimental designs; coordinate and execute pre-formulation, formulation, and process development studies; identify challenges and recommend solutions.
- Conduct pre-formulation/formulation studies using techniques such as TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, and light microscopy.
- Work with internal and external partners to meet formulation needs.
- Develop safe, viable, robust formulations for water-insoluble compounds via multiple routes of administration.
- Perform formulation and process technology transfers to external partner sites and monitor CDMO activities.
- Conduct phase-appropriate risk assessments (QbD) based on target product profiles.
- Support formulation/process scale-up and optimization using DoE and other modeling tools.
- Provide support for formulation development and transfers to contract manufacturing organizations.
- Oversee maintenance/calibration of laboratory instrumentation; maintain safe lab conditions and uninterrupted supply of materials.
- Summarize work in reports; present plans/results to teams.
- Author drug product sections of regulatory submissions (IND, CTA amendments, NDA, MAA) as needed.
- Maintain experimental records; mentor junior team members; perform other assigned tasks.
Qualifications/Required:
- PhD (2+ years) or Master’s (4+ years) or Bachelor’s (6+ years) in pharmaceutical science, material science, chemistry, or related field with relevant discovery formulation/pre-/formulation experience.
Skills/Required:
- Hands-on formulation development and characterization of liquid/solid dosage forms; proficiency with relevant formulation equipment.
- Understanding of physical pharmacy and engineering concepts; strong scale-up principles.
- Proficiency with Microsoft Office; excellent written/verbal communication.
- Ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Analytical problem-solving, planning/organization/time management.
Preferred:
- Experience working with CMOs; familiarity with oral/parental route formulations; electronic lab notebook.
- Instrument troubleshooting (e.g., HPLC, DSC, KF, X-ray diffractometer, hot stage microscopy, TGA, etc.).
- Working knowledge of US/international CMC regulations (GMP, 21 CFR, ICH).
Travel: 0–10%
Compensation/Benefits:
- Base salary range: $133,100–$158,000; eligible for short- and long-term incentives and medical/dental/vision and retirement savings plans.
Primary Duties/Responsibilities:
- Design and develop robust formulations and manufacturing processes for small molecule compounds for preclinical and clinical studies.
- Prepare experimental designs; coordinate and execute pre-formulation, formulation, and process development studies; identify challenges and recommend solutions.
- Conduct pre-formulation/formulation studies using techniques such as TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, and light microscopy.
- Work with internal and external partners to meet formulation needs.
- Develop safe, viable, robust formulations for water-insoluble compounds via multiple routes of administration.
- Perform formulation and process technology transfers to external partner sites and monitor CDMO activities.
- Conduct phase-appropriate risk assessments (QbD) based on target product profiles.
- Support formulation/process scale-up and optimization using DoE and other modeling tools.
- Provide support for formulation development and transfers to contract manufacturing organizations.
- Oversee maintenance/calibration of laboratory instrumentation; maintain safe lab conditions and uninterrupted supply of materials.
- Summarize work in reports; present plans/results to teams.
- Author drug product sections of regulatory submissions (IND, CTA amendments, NDA, MAA) as needed.
- Maintain experimental records; mentor junior team members; perform other assigned tasks.
Qualifications/Required:
- PhD (2+ years) or Master’s (4+ years) or Bachelor’s (6+ years) in pharmaceutical science, material science, chemistry, or related field with relevant discovery formulation/pre-/formulation experience.
Skills/Required:
- Hands-on formulation development and characterization of liquid/solid dosage forms; proficiency with relevant formulation equipment.
- Understanding of physical pharmacy and engineering concepts; strong scale-up principles.
- Proficiency with Microsoft Office; excellent written/verbal communication.
- Ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Analytical problem-solving, planning/organization/time management.
Preferred:
- Experience working with CMOs; familiarity with oral/parental route formulations; electronic lab notebook.
- Instrument troubleshooting (e.g., HPLC, DSC, KF, X-ray diffractometer, hot stage microscopy, TGA, etc.).
- Working knowledge of US/international CMC regulations (GMP, 21 CFR, ICH).
Travel: 0–10%
Compensation/Benefits:
- Base salary range: $133,100–$158,000; eligible for short- and long-term incentives and medical/dental/vision and retirement savings plans.