Scientist II, Formulation Development

About the role

PTC Therapeutics is a global commercial biopharmaceutical company dedicated to extending life’s moments for children and adults living with rare diseases. The Scientist II, Formulation Development actively contributes to drug discovery and drug product development by designing, manufacturing, and characterizing phase-appropriate formulations and processes. This role ensures a timely supply of formulations or drug product for discovery, preclinical, and clinical studies, working cross-functionally with internal departments and external partners.

Responsibilities

• Designs and develops robust formulations and manufacturing processes for small molecule compounds from drug discovery and/or development programs for preclinical and clinical studies.
• Prepares experimental designs, evaluates data, coordinates and executes pre-formulation, formulation, and process development studies, and identifies pharmaceutical development challenges while recommending potential solutions.
• Conducts pre-formulation and formulation studies using techniques such as TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, and pH.
• Works with internal and external partners to meet formulation needs.
• Develops safe, viable, and robust formulations using pharmaceutically acceptable inactive ingredients to enable the delivery of water-insoluble compounds by multiple routes of administration.
• Conducts formulation and process technology transfers to external partner sites and monitors activities at CDMOs to meet PTC’s project timelines.
• Designs studies and conducts phase-appropriate risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
• Conducts formulation and process scale-up and optimization studies using QbD tools, including design of experiments (DoE) and other modeling and scale-up tools.
• Provides pre-formulation, formulation, and manufacturing support for drug product formulation development and transfer to contract manufacturing organizations.
• Independently oversees the maintenance and calibration of laboratory instrumentation (e.g., TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH).
• Maintains safe laboratory working conditions and ensures a steady supply of raw materials, reagents, supplies, and tools.
• Summarizes experimental work in reports and presents study plans and results to broader teams in a timely manner.
• Authors drug product sections of regulatory submissions such as INDs, CTAs, NDAs, or MAAs.
• Maintains appropriate experimental records in laboratory notebooks.
• Mentors and coaches junior team members.
• Performs other tasks and assignments as specified by management.

Requirements

• PhD in pharmaceutical science, material science, chemistry, or related discipline with a minimum of 2 years of relevant experience, or Master’s degree in the same disciplines with at least 4 years of relevant experience, or Bachelor’s degree in the same disciplines with a minimum of 6 years of relevant experience in discovery formulation, pre-formulation, or formulation development.
• Hands-on experience and proficiency with basic laboratory skills, design, development, and characterization of liquid and solid dosage forms using formulation equipment (e.g., blenders, granulators, roller compactors, tablet presses, coaters, fluid-bed dryers).
• Proven understanding of physical pharmacy and engineering concepts in formulation and process development, including scale-up principles.
• Proficiency in working with and overseeing CMOs for formulation development and manufacture is desirable.
• Proficiency with Microsoft Office applications.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
• Analytical thinker with strong problem-solving skills and adaptability to changing priorities and deadlines.
• Strong planning, organization, and time management skills, including the ability to support and prioritize multiple projects.

Preferred Qualifications

• Familiarity with the preparation of formulations for drug discovery and clinical support by oral and parenteral routes of administration.
• Understanding of physical chemistry and physical pharmacy as they relate to preformulation and formulation concepts.
• Experience using electronic lab notebooks.
• Hands-on experience using and troubleshooting analytical instruments (e.g., HPLC, DSC, light microscopy, Karl Fisher, X-ray diffractometer, hot stage microscopy, TGA).
• Working knowledge of US and international CMC regulations and guidance, including GMP, 21 CFR, and ICH guidelines.

Pay

Expected base salary range: $133,100–$158,000. The base salary offered will be contingent on candidate education, background, and experience, as well as internal equity. Eligible employees may also receive short- and long-term incentives.

Benefits

• Medical, dental, and vision plans.
• Retirement savings plans.

Schedule

Travel requirements: 0-10%.