Purdue Pharma Work Values

Daily Duties at Purdue Pharma:

Auditor – Manufacturing Quality Assurance (2003 – 2004) Played a lead role in the completion of successful FDA audits. Audited the manufacturing facilities of P.F. Labs to ensure the quality of raw materials compliant with FDA and DEA regulations. Maintained and coordinated PDKM auditing support at the Ardsley Manufacturing facility. Qualified vendors for compliance of raw materials testing and distribution.  Saved the company both time and money by driving improvement in the quality of timely batch disposition and release of tested raw materials for regulated Pharmaceutical manufacturing.  Dramatically cut the number of rejected batches by 95%. Qualified 8 vendors to guarantee the use of quality product in manufacturing. Associate Research Scientist – Pharmacokinetic and Drug Metabolism Group (PKDM) (2001 – 2003) Developed, validated, executed and revised clinical and nonclinical bio-analytical LC-MS/MS methods while serving concurrently as Reference Standard Program Administrator, DEA Core Team Member and Analytical License Sub Team Chair. Analyzed data, drafted reports, and investigated assay failures. Audited contracted laboratories and personnel to ensure GLP compliance and consistently high levels of support.  Served as DEA Core Team Member and Lead scientist for a drug therapy program that positioned the company for significant additional revenue growth.  Enhanced the company’s visibility within the industry. Co-authored a scientific poster for a national conference presentation of company scientific expertise and state of art technology. Bioanalytical Laboratory Manager (2000 – 2001) Guided the operations of 4 regulated bio-analytical sample preparation and analysis laboratories while serving as the Reference Standard Program Administrator. Additionally served as DEA Core Team member and Analytical License Sub Team Chair. Ensured CRO compliance with GLP requirements as well as internal staff compliance with departmental regulations and equipment operating procedures. Played a key role in delivering successful DEA and FDA audits. Assessed and implemented changes to drug compound storage and dispensing for all Purdue U.S. facilities. Directed consumable and equipment procurement. Ensured the timely maintenance and reliable operation peripheral lab equipment used for sample processing. Authored all related documents and delivered all necessary related training.  Improved compliance with FDA and DEA guidelines. Designed and implemented a novel and compliant storage and dispensing system for departmental reference standard drug compounds.  Improved operational efficiency as well as the utilization of lab resources. Developed and implemented more efficient lab layouts and procedures. Research Associate and Scientist (1998 – 2000) Supported clinical and nonclinical toxicology studies while providing data in support of regulated FDA submissions. Developed, validated and executed sample extraction methods using Tomtec and Packard robotic systems. Recovered and analyzed various Pharmaceutical drugs and metabolites from many biological matrices. Analyzed samples using LC-MS/MS Procured and maintained DEA schedule controlled and non-controlled reference standard inventory.  Dramatically improved quality and accuracy of generated bio-analytical concentration data through the development of highly pure and certified drug standards. o Managed systhesis budget of approximately $4 million annually. o Qualified more than 5 synthesis and analytical testing vendors as well as 8 equipment calibration and maintenance vendors.

What they like about Purdue Pharma:

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Tags

Principal Investigator, Project Manager, Team Leader, Bioanalytical, Principal Scientist

Skills

These are some of the questions we asked our climbers about their experiences with Purdue Pharma: