Principal Scientist, Analytical Development

Job Title

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 suchas 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.