Job Description Summary:
The Associate Scientist I, Formulation Development actively contributes to drug discovery and drug product development by designing, preparing and characterizing formulations; ensuring a timely supply of formulations for discovery, preclinical, and clinical studies; and performing pre-formulation and formulation characterization studies to support drug product development. This involves performing lab activities, analyzing the data, planning studies & communicating lab results to cross-functional team members and line management, and presenting results to stakeholders as required.
The Associate Scientist I, Formulation Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Under minimal supervision:
- Designs & develops formulations for small molecule compounds from drug discovery and development programs for preclinical and clinical studies (both oral and parental dosage forms).
- Monitors chemical and physical stability and incompatibility of formulations for pre-clinical and clinical studies.
- Prepares and runs samples for the physical and chemical characterization of compounds from drug discovery and development programs using various techniques (TGA/DSC, XRPD, PSD, HPLC/UPLC, UPLC/MS, light microscopy, pH, etc.).
- Coordinates with internal and external groups as necessary to supply formulations to execute pre-clinical & clinical studies on schedule (Chemistry, Pharmacology, DMPK, Shipping services, Clinical Supply, Analytical etc.).
- 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.
- Summarizes and presents characterization data on formulations in reports and presentations prepared and issued in a timely manner.
- Conducts troubleshooting of pre-formulation & formulation (discovery & clinical) challenges and recommends potential solutions.
- Conducts pre-formulation and formulation studies on compounds that are nominated for discovery & clinical development; identifies pharmaceutical development challenges for such compounds and recommends potential solutions.
- 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.
- Collaborates with members of the Formulation Development and/or Analytical Development groups on projects in discovery & clinical development.
- Maintains appropriate experimental records in electronic laboratory notebooks.
- 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.
- 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.
- Master's degree in pharmacy or pharmaceutical science, material science, chemistry, or other related scientific discipline and 0-1 year of discovery formulation, pre-formulation or formulation development experience or a Bachelor's degree in these same disciplines and a minimum of 2 years of relevant experience in discovery formulation, pre-formulation or formulation development in a pharmaceutical, biotechnology or other related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Hands-on experience and demonstrated proficiency with basic laboratory skills such as weighing, pH measurements, light microscopy, preparation and characterization of liquid and solid dosage forms, etc.
- Ability to learn how to prepare formulations for drug discovery support by both oral and parental routes of administration.
- Hands-on experience with analytical instruments [e.g., pH meter, Dissolution baths / PION, High-Pressure Liquid Chromatography (HPLC/UPLC), thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), polarized light microscopy (with and without hot stage), Karl Fisher (KF), X-ray diffractometer), particle size distribution (PSD), and Ultra Performance Liquid Chromatography / mass spectrometry (UPLC/MS)].
- 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.
- Familiarity with the preparation of formulations for drug discovery and clinical support by both oral and parental routes of administration.
- Understanding of physical chemistry and physical pharmacy as they relate to concepts in preformulation 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.
* Travel and Physical requirements
- 0-10%
- Office/ Laboratory based position
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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