Post-Doc - Analytical Development

Purdue Pharma L.P. Coventry, RI
Job Summary

Working closely with senior staff, this position will be responsible for analytical method development and validation

Primary Responsibilities

* Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP, DEA, and company policies and procedures.

* Ensure high quality in analytical work and accurately document all necessary and relevant information in a clear concise manner as per cGMPs.

* Develop / improve and validate robust analytical methods that are GMP friendly based on quality-by-design and document formal protocols and reports.

* Perform stability testing and data trending.

* Review experimental data, notebooks, and instrument qualification protocols / reports.

* Actively participate in investigations, problem solving, and troubleshooting. Write investigation reports.

* Prepare and present data summaries (written and oral) as necessary. Present to cross functional teams and effectively communicate critical analytical issues and solutions.

* Write, revise, develop, and evaluate SOPs.

* Perform analytical method transfers to third party organizations.

* Operate and maintain all analytical instrumentation and equipment as per established procedures.

* Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.

* Support identification and qualification of API related impurities and degradants.

* Maintain good laboratory practices in compliance with safety and environmental requirements.

* Ability to work successfully in both a team/matrix environment as well as independently.

* Performs other related assignments and duties as required and assigned.

Education and Experience

* PhD in chemistry with a concentration in analytical chemistry.

* Demonstrated knowledge of analytical chemistry, separation sciences, spectroscopy, and a variety of hands-on analytical techniques.

* Working knowledge of industry guidance (GMP, GLP, etc.).

* Prior experience in pharmaceutical method development, validation, and transfer preferred.

* Understanding of risks in all aspects of method development, validation, and transfer and the ability to use risk analysis and quality-by-design approaches.

* Ability to problem solve and trouble shoot.

* Skillful in HPLC, GC, dissolution, FTIR, UV, LC/MS, KF, and wet chemistry.

* Knowledge of Waters Empower chromatography software and Waters online HPLC Automated Dissolution.

Necessary Knowledge, Skills, and Abilities

* Must be able to perform analytical tasks and complete assignments on time with supervision.

* Organization and coordination of activities for assigned tasks is crucial to keep projects on time and within budget.

* Must be able to develop robust methods, design appropriate validation protocols and conduct successful method validation and transfer.

Supervisory Responsibilities (if Applicable)

N/A

Additional Information

This position is for a one year duration.

Rhodes Pharmaceuticals is committed to our customers. We achieve our mission through our people who are our strength, who are relentless and possess a passion for providing quality products to meet the needs of patients.