Job Description
Job Description
OBJECTIVES:
- We are seeking to fill a contractor position reporting to the Global Chemistry organization in Cambridge, MA to prepare formulated API for in vivo PK, pharmacology, and safety studies.
- This role entails collaboration with a wide range of cross-functional research project teams, external CRO collaborators, and Client Pharm Sci colleagues to develop project specific formulation strategies for in vivo studies (PK, efficacy, tox), enabling the rapid advancement of compounds from PE through CN and CS.
ACCOUNTABILITIES:
- Prepares and optimizes pre-clinical drug formulations using appropriate technology and scientific principles for in vivo PK, Pharmacology, and safety studies
- Conducts limited screening of known excipients, pH adjustment, etc, and chemical/physical stability check for program compounds. Prepares cassette dosing solutions for PK screening.
- Conducts experiments and analyzes/shares data to support project progression using analytical instrumentation (HPLC, Mass Spec) to assess formulation stability and chemical stability
- Accurately records formulation experiments/protocols in an e-notebook
- Prepares/shares formulation protocols, technical reports, presentations, and regulatory documents as necessary
- Adherence to lab safety and quality protocols
o Ensures formulations meet IUCUC guidelines and industry standards in coordination with in vivo study director
o Understanding and ability to implement good laboratory practices, particularly in handling preclinical pharmaceutical small molecule API for neuroscience, immunology, and oncology indications
- Collaborates with a Global Chemistry manager, cross-functional research project teams, CROs, the Comparative Medicine group, and Pharmaceutical Science colleagues to provide project specific formulations and formulations strategies for in vivo studies (PK, efficacy, tox)
- Continuous review and learning of formulation science through reading the literature and active engagement with client Pharm Sci group and CROs to guide project formulation strategy
- Exceptional organizational skills will be required, as the role requires receiving, managing, and delivering on requests from a wide range of groups and teams across the Research organization, often under tight timelines