MS&T Senior Scientist - Small Molecule Drug Substance

Vertex Inc.•Boston, MA

1d•$120,000 - $180,000•Onsite

About The Position

The MS&T Senior Scientist exercises a high level of experimental productivity contributing to the advancement of projects in pharmaceutical development or commercial manufacturing and may be running chemistry on multiple projects concurrently. This role requires bench chemistry as well as the management of projects, including roles on cross-functional project teams representing MS&T. This role will interpret complex chemistry, may champion new technologies and involve an increasing knowledge of related scientific disciplines, including regulatory and quality compliance. Cross functional association with Analytical Sciences & Technology (AS&T) Supply Chain management (SCM), Quality (QA) and Regulatory is expected, along with change management activities.

Requirements

Experience in writing and transferring developed technology to outside CDMOs and working with suppliers to solve chemical issues for compound delivery.
Excellent synthetic chemistry laboratory skills.
Ability and track record of successfully working in cross-functional teams.
Deep understanding and knowledge of SOPs and GMPs and ensure compliance with all applicable regulations and SOPs.
Excellent verbal and written communication skills to exchange complex technical/scientific information with others in complex situations and to prepare presentations and reports as required.
Ability to interact/communicate with various levels throughout the organization.

Nice To Haves

Experience and ability to support CMC sections of INDs is preferred

Responsibilities

Manages technical transfer and manufacturing collaborations with external CDMOs, including extensive documentation and change control management.
Performs synthetic organic experiments efficiently, independently and in a fit-for-purpose fashion for the stage of development (clinical through process validation to commercial).
Performs reaction process monitoring using a variety of analytical methods and work with analysts developing sufficient methods.
Generates effective hypotheses to pursue synthesis or manufacturing goals and set new experimental direction as necessary.
Contributes to department/group discussions and departmental initiatives
Impacts and participates in cross-functional teams
Demonstrates a practical and advanced understanding of related scientific disciplines
Communicates and enables the effective dissemination of advanced ideas, internally and externally
Multitasks to effectively manage multiple activities/projects.
Provides technical recommendations regarding process chemistry by assisting other chemists in the department and/or articulating issues to management.
Makes conceptual contributions to development activities and scientific strategies.
Provides on the job training and support to other scientists on day-to-day experiments and assists with ensuring compliance with relevant regulations and SOPs.
Develops internal reports and regular updates at appropriate project intervals and contributes to regulatory documents.