Research Associate I, Formulation Development at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

Job Description:

In this newly created role, the Research Associate I, Formulation Development contributes to the drug discovery and drug product development process by developing and supporting formulations for preclinical and clinical evaluation and performing pre-formulation characterization studies to support drug product formulation development.

This position works cross-functionally with internal departments and external resources on formulation support related issues. 

The Research Associate I, Formulation Development supports adherence to relevant sound scientific lab practices, regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

• Under guidance from the supervisor, develops formulations for compounds from drug discovery and clinical phase development programs for evaluation in pharmacokinetic (PK), efficacy, and other pharmacology studies; develops formulations that enable the delivery of water insoluble compounds in preclinical and clinical studies by providing safe and viable formulations composed of pharmaceutically acceptable vehicles and excipients dosed by multiple routes of administration.

• Under guidance from the supervisor, conducts troubleshooting of drug discovery and clinical formulation development challenges and recommends potential solutions.

• Under guidance from the supervisor, conducts pre-formulation and formulation studies on compounds that are nominated for early clinical development; identifies pharmaceutical development challenges for such compounds and recommends potential solutions.

• Under guidance from the supervisor, provides pre-formulation, formulation, and manufacturing support for drug product formulation development; provides supporting development data for the transfer of formulation development to contract manufacturing organizations, as necessary.

• Summarizes and presents characterization data on development candidates in reports and presentations prepared and issued in a timely manner.

• Maintains appropriate experimental records in electronic laboratory notebooks.

• Maintains safe laboratory working conditions and maintains a steady uninterrupted supply of raw materials, reagents, supplies, and any required tools as necessary.

• Performs other tasks and assignments as needed and specified by management. 

* Minimum level of education and years of relevant work experience.

• Bachelor’s degree in material science, chemistry, chemical engineering or other related scientific discipline with minimum of 1 year of relevant academic or professional experience preferably in the areas of pre-formulation, formulation or manufacturing process development.

* Special knowledge or skills needed and/or licenses or certificates required.

• Applied, hands-on experience and demonstrated ability to perform laboratory activities under the supervision of a more senior scientist.

• Proficiency in Microsoft Office.

• Excellent written and verbal communication 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 formulation and process equipment including analytical/microbalance, tablet press, roller compactor, sieving, blending and preformulation / solid state characterization instruments (e.g., thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), light microscopy (with hot stage), X-ray diffractometer).

• Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization.

• Understanding of organic and polymer physical chemistry and physical pharmacy as they relate to concepts in pre-formulation and formulation.

• Experience using electronic lab notebook.

• Ability to learn US and international Chemistry, Manufacturing and Control (CMC) regulations and guidance, including Good Laboratory Practice (GxP), the US Code of Federal Regulations (21CFR) and International Conference of Harmonization (ICH) guidelines.

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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