Principal Scientist, 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 lifes 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 Principal Scientist, Formulation Development primarily contributes to the early- and late-stage formulation and process development of oral drug products. The position contributes to drug product development and life cycle management by designing and developing formulations and processes for preclinical & clinical evaluations as well as for commercial technology transfer.

This position works cross-functionally with internal departments and external partners on formulation and process development related issues.

The Principal Scientist, Formulation Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
. Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Designs studies and conducts risk assessments as per target product profiles to build in quality-by-design (QbD) during formulation and process development.
• Develops robust formulations and manufacturing processes for Phase I-III clinical studies and assists in their transfer to Contract Manufacturing Organizations (CMOs).
• Develops alternate formulations for current commercial products through life cycle management as required.
• Assists in monitoring formulation and process development activities at CMOs to meet PTCs project timelines.
• Conducts process scale up and optimization studies using various QbD tools including design of experiments (DoE) and other modeling and scale-up tools.
• Supports formulation and process technology transfers to commercial manufacturing sites.
• Conducts troubleshooting of formulation & processing related challenges and recommends potential solutions.
• Provides formulation and process development support to enable delivery of water insoluble compounds in preclinical and clinical studies by providing viable options of pharmaceutically acceptable formulations.
• Prepares experimental designs, evaluates data and coordinates and executes preformulation, formulation, and process development studies on compounds that are nominated for clinical development; identifies pharmaceutical development challenges for such compounds and formulations, conducts risk assessments, and recommends potential solutions.
• 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.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum level of education and years of relevant work experience:

• Masters degree in a pharmacy, chemical engineering or chemistry related discipline and a minimum of 8 years of experience in preformulation and formulation development in a pharmaceutical, biotechnology or other related environment OR a PhD degree in a pharmacy or chemistry related discipline and a minimum of 5 years of experience in preformulation and formulation development in a pharmaceutical, biotechnology or other related environment.

Special knowledge or skills needed and/or licenses or certificates required:

• Hands-on experience using formulation equipment such as blenders, granulators, roller compactors, tablet presses, coaters, fluid-bed dryers etc.
• Hands-on experience in design and development of oral solid dosage forms for clinical studies and commercialization.
• Proven understanding of physical pharmacy & engineering concepts in formulation and process development and related scale-up principles.
• Proficiency in working with and overseeing CMOs for formulation development and manufacture for PTC projects is desirable.
• Proficiency with Microsoft Office applications.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Special knowledge or skills and/or licenses or certificates preferred:

• Hands-on experience using and troubleshooting analytical instruments (e.g., High Pressure Liquid Chromatography (HPLC), differential scanning calorimetry (DSC), light microscopy, Karl Fisher (KF), X-ray diffractometer), hot stage microscopy, thermogravimetric analyzer (TGA), etc.
• Experience using electronic lab notebook.
• Working knowledge of US and international Chemistry, Manufacturing and Control (CMC) regulations and guidance, including Good Manufacturing Practice (GMP), the US Code of Federal Regulations (21CFR) and International Conference of Harmonization (ICH) guidelines is desired.
• Use of Microsoft Project and managing timelines.

Travel requirements:

• Up to 10%

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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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