Preclinical Formulation Scientist - Research Analyst

Position Title: Preclinical Formulation Scientist - Research Analyst

Work Location: Cambridge, MA 02139

Assignment Duration: 10 months (possible Extension)

Work Arrangement: Onsite

Position Summary:

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 The Organization Pharm Sci colleagues.

Background & Context:

The role's purpose is 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.

Qualification & Experience:

• Bachelor’s degree in a chemistry or pharmaceutical science, or equivalent with 5 years of experience, or Master's degree with 3 years of experience in formulating small molecule APIs
• Broad knowledge of acceptable excipients and equipment/instruments widely used in pre-clinical formulation preparation
• Demonstrates technical knowledge of formulations and pharmaceutics of small molecule APIs including:
• Solubilizing/solution formulations
• Solid/suspension formulations
• Well-versed in analytical instrumentation (HPLC, Mass Spec) to assess:
• Formulation stability (physical)
• Chemical stability
• A good understanding of pre-clinical formulation science
• Exceptional organizational skills
• Strong attention to detail, communication, and teamwork

Key Responsibilities:

• 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
• Ensures formulations meet IUCUC guidelines and industry standards in coordination with in vivo study director
• 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 The Organization 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