This position will support drug development through analytical method development, validation, transfer, stability testing and activities to support formulation development and clinical studies in compliance with all applicable guidelines with minimum supervision. This position will develop and author laboratory Standard Operating Procedures (SOPs), methods, protocols, and reports. Supports work related to production, R&D and NDA/ANDA filings. This position will be responsible for laboratory instrument troubleshooting and routine maintenance to ensure they are in compliance with established procedures and cGMPs requirements. This position will maintain accuracy in laboratory operations, scientific data, and notebook writing as well as responsible for review, interpretation, compilation of results and preparing scientific reports. This role may independently identify/observe problems and recommend experimental strategies and solutions.
- 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 contract 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.
- Provide training and assistance to other group members.
- 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.
B.S. in Chemistry or Pharmaceutical Chemistry with 10 plus years of relevant experience. MS or PhD a plus.
Required Experience & Technical Requirements
- Demonstrated knowledge of analytical chemistry, separation sciences, spectroscopy, and a variety of hands-on analytical techniques.
- Thorough understanding and working knowledge of industry guidance (GMP, GLP, etc).
- Experience in pharmaceutical method development, validation and transfer.
- 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 solving and trouble shooting.
- 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.
- Prior experience in finished dosage for the generic market.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 17 months ago