Principal Scientist

Responsibilities:

Conduct analytical method development, validation, and project support. Identifies technical challenges during analytical method development and performs method troubleshooting.

Manage CMO/CRO analytical project resources as required such as contractors and contract laboratories.

Manage technical direction of analytical projects; identify key deliverables and next steps and communicate to the team.

Responsible for data review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.

Identify and implement new techniques and instrumentation to expand internal capabilities.

Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents.

Performs the assigned analytical tasks with minimum supervision in support of product development and clinical trial materials.

Performs activities within the assigned timelines and in compliance with cGXP's, regulatory requirements, and company practices and procedures.

Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development.

Manage day-to-day laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, maintaining equipment and calibrations with various vendors.

Qualifications:

Degree in chemistry, pharmaceutics, or related field; advanced degree is a plus.

10+ years experience in analytical method development, validation and drug product development activities regulated by FDA.

Working knowledge of standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).

Ability to work well both independently and with a team.

Excellent written and verbal communication skills.