Senior Principal Analytical Chemist

Job Description

This is an exciting opportunity for individuals with analytical chemistry experience to develop and perform analytical experiments under the direction of the Sr. Director, Analytical Chemistry, or other team members.

The candidate will support the company’s contract development and manufacturing services to ensure business objectives are met for execution of API development as well as commercial projects. The candidate will personify the organization’s shared values and culture, both internally and externally.

Essential Job Duties & Responsibilities

• Independently conduct analytical method development, validation, and project support
• Work closely with QC department
• Identify technical challenges during analytical method development and perform analytical method troubleshooting
• Manage CMO/CRO analytical project resources as required such as contractors and contract laboratories, as needed
• 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 material
• 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

Experience & Qualifications

• P.D. with a minimum 10 years of experience in analytical method development, validation and API and/or drug product development activities regulated by FDA, M.S with a minimum 15 years of experience, or B.S. degree with a minimum 20 years of experience in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field
• Ability to work well both independently and with a team
• Broad range of functional expertise in analytical chemistry, compound purification, spectral analysis/interpretation
• Experience with common analytical techniques such as: HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS, Raman, FTIR
• Knowledge of ICH and cGMP requirements
• Experience working for a contract organization (CROs/CMOs/CDMOs) is a plus
• Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus
• Experience with the development and implementation of Process Analytical Technology (PAT) is a plus
• Experience with Design of Experiments (DOE) is a plus