Scientist II, Formulation Development

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Scientist II, Formulation Development actively contributes to drug discovery and drug product development by designing, manufacturing, and characterizing phase-appropriate formulations and process; ensuring a timely supply of formulations or drug product for discovery, preclinical, and clinical studies. This involves performing lab activities, analyzing the data, planning studies and communicating lab results to cross-functional team members and line management, and presenting results to stakeholders as required.

The incumbent works cross-functionally with internal departments and external partners on formulation development related issues.
The Scientist II, Formulation Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.


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Job Description:

ESSENTIAL FUNCTIONS

Primary duties/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, and recommends potential solutions.
• Conducts pre-formulation and formulation studies using various techniques (TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH, etc.).
• Works with internal and external partners as necessary to meet formulations needs.
• Develops safe, viable and robust formulations using pharmaceutically acceptable inactive ingredients that 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 & process scale up and optimization studies using various 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 for the transfer of formulation development to contract manufacturing organizations, as necessary.
• Independently oversees the maintenance and calibration of laboratory instrumentation within the group (TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH, etc.).
• Maintains safe laboratory working conditions and maintains a steady uninterrupted supply of raw materials, reagents, supplies, and any required tools as necessary.
• Summarizes experimental work in reports, presents the study plans and results to broader teams in a timely manner.
• Authors the drug product sections of regulatory submissions such as Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), or their amendments, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) as necessary.
• Maintains appropriate experimental records in laboratory notebooks.
• Mentors and coaches junior team members.
• Performs other tasks and assignments as needed and specified by management.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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