Analytical Chemist

---

Job description

Overview

This role will execute on moderately complex research and development activities as assigned by management, including analysis of drug samples using various analytical techniques. Work with project team members to support development of drug delivery platform products. Participate in formulation support, method development and validation, the maintenance and troubleshooting of laboratory equipment, and where necessary, coordinate outsourcing of testing and method development with vendors.

Responsibilities

* Execute the method development and validation in drug delivery development.
* Lead method transfers from internal and external groups to QC.
* Prepare and analyze samples according to established test methods.
* Responsible for analytical chemistry testing using a variety of analytical techniques.
* Write analysis reports.
* Calibrate instrumentation on a scheduled basis.
* Troubleshoot equipment and test method issues.
* Lead test method characterization and validation activities.
* Coordinate with supervisor on scheduling of testing reagents and products.
* Participate in data review.
* Adhere to Good Documentation Practices and data integrity principles (maintaining contemporaneous records, filling out logbooks, forms, etc.)
* Coordinate external outsourcing and testing.
* Lead method improvements and optimization exercises to improve analytical throughput (i.e. cost reduction.).
* Work to GMP & GCLP principles.

Qualifications

* Bachelor's Degree in Chemistry or related field
* Minimum of 5 years of related experience.
* Experienced in numerous analytical techniques to characterize raw materials, drug substances and drug products. Typical advantageous experience includes, HPLC/UPLC, DVS, DSC, TGA, SEM, FTIR, KF, LAL, particle size/laser diffraction (geometric/aerodynamic), XRPD.
* In-vitro dissolution and/or analysis of sustained release dosage forms using USP apparatus (preferred).
* Method Development and Validation experience required.
* Operation in a GMP industry preferred.
* Knowledge of safe laboratory practices.
* Strong verbal and written communication skills.
* Knowledge of CFR 210,211, USP and FDA/ICH guidance.
* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
* Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
* Network with senior internal and external personnel in own area of expertise