Analytical Scientist II

About the role

The Analytical R&D Scientist II position requires skill and knowledge of various separation science platforms such as HPLC/UPLC, GC and GC-HS, with a focus on degradation/impurity analysis, API/Preservative Assays and Residual Solvent analysis. This position assists in developing these methods, performs method validations/verifications from start to finish and drafts the associated protocols and reports. Additionally, this position requires knowledge and skill at basic analytical laboratory techniques.

Responsibilities

• Proficient understanding of knowledge in the areas of:cGMP/GLP
• Understanding
• Working with standard lab equipment, instruments, and processes
• Working principles of major analytical techniques
• Perform both routine and non-routine testing on Drug Product, Drug Substance (API) and excipients.
• Perform full Stability Testing on Drug Products to support FDA filings. (including Physical tests, Assay and Impurity testing)
• Perform preliminary testing on products in the Development phase as requested by the Product Development group.
• Capable of performing investigations independently or with minimal guidance, and able to assist in developing related procedures.
• Demonstrates ability to manage small to medium sized projects.
• Able to accurately write and review analytical data, test methods, validation/verification protocols, and reports.
• Demonstrates ability to develop less complex methods as needed.
• Able to provide solutions to various technical problems of moderate scope and complexity.
• Perform troubleshooting of OOS/OOT/Aberrant results.
• Able to perform timely and precise peer reviews of fellow Scientist’s work.
• Willingness to train lower-level scientists on new skills.
• Maintain a GMP compliant laboratory environment.

Requirements

• Ability to work independently and effectively prioritize tasks.
• Ability to take direction from senior team members.
• Strong written and verbal communication skills.
• Demonstrates initiative in learning new skills and concepts.
• Strong background in HPLC/UPLC and GC; Advanced instrument and method troubleshooting skills are required.
• Proficiency with the use of chromatographic software applications such as Syngistix, OpenLab, and Empower.
• Proficiency in basic laboratory techniques such as pH, Karl Fischer, UV/Vis, FTIR, Particle Size Analysis, etc.
• Proficiency in performing Wet Chemistry analyses (such as USP Identification Tests).
• Proven ability to adhere to good documentation standards and maintain detailed records of all work performed.
• Experience with and/or knowledge of the regulatory requirements including knowledge of appropriate control and testing strategies.
• Knowledge of ICH/USP guidelines relating to analytical method validation/verification.

Preferred Qualifications

• Experience with and/or knowledge of the regulatory requirements including knowledge of appropriate control and testing strategies.
• Basic knowledge of LC/MS, GC/MS and ICP/MS instrumentation and techniques (Such as Elemental Impurities, Extractable/Leachables and Nitrosamines).

Education And Experience

• BS + 4 years relevant experience or MS + 0 – 2 years relevant experience