Formulation Scientist

Job Description Summary:

The Contractor, Formulation Development actively contributes to formulation & process development, process scale up and validation readiness of small molecules (early to late stage) by designing, preparing and characterizing of formulations; ensuring a timely supply of formulations for preclinical, and clinical studies; and performing pre-formulation and formulation characterization studies to support drug product development. This involves performing lab & manufacturing activities, working with external CDMOs, analyzing the data, planning studies & communicating lab results to cross-functional team members and line management, authoring technical reports and regulatory source documents, and presenting results to stakeholders as required. The Contractor, Formulation Development, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

JOB SUMMARY

The Contractor, Formulation Development actively contributes to formulation & process development, process scale up and validation readiness of small molecules (early to late stage) by designing, preparing and characterizing of formulations; ensuring a timely supply of formulations for preclinical, and clinical studies; and performing pre-formulation and formulation characterization studies to support drug product development. This involves performing lab & manufacturing activities, working with external CDMOs, analyzing the data, planning studies & communicating lab results to cross-functional team members and line management, authoring technical reports and regulatory source documents, and presenting results to stakeholders as required.

The Contractor, Formulation Development, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Under limited Supervision:

· Designs & develops formulations & process for small molecule compounds from drug discovery and development programs for preclinical & clinical studies as well as for commercial validation readiness (both oral and parental dosage forms).

· Monitors chemical and physical stability and incompatibility of formulations. 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 technical reports, regulatory source documents, and presentations prepared and issued in a timely manner.

· Conducts troubleshooting of pre-formulation, formulation, and manufacturing process challenges 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.

· Ph.D. or a Master’s degree or a Bachelor’s degree in pharmacy or pharmaceutical science, material science, chemistry, or other related scientific discipline and a minimum of 5 years of relevant experience in formulation and process 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 both oral and parental routes of administration.

· Hands-on experience with equipment/instruments [e.g., blenders, screens, mills, dry and wet granulators, tablet compression machines, capsule filling machines, mixers, liquid filling machines, 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.

· 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.