This position will work with senior staff for analytical method development, validation, transfer, stability testing and activities to support formulation development and clinical studies in compliance with all applicable guidelines. This position will develop and author laboratory Standard Operating Procedures (SOPs), methods, protocols, and reports. 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.
- Develop, validate and transfer robust analytical methods that are GMP friendly and document formal protocols and reports.
- Perform stability testing and data trending.
- Review experimental data, notebooks and instrument qualification protocols / reports.
- Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
- Actively participate in investigations, problem solving and troubleshooting. Write investigation reports.
- Prepare and present data summaries (written and oral) as necessary.
- Write, revise, develop and evaluate SOPs.
- Operate and maintain all analytical instrumentation and equipment as per established procedures.
- Provide training and assistance to other group members.
- 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. or M.S. in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry.
Required Experience & Technical Requirements
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.
- Demonstrated knowledge of analytical chemistry, separation sciences, spectroscopy, and a variety of hands-on analytical techniques.
- Good understanding and working knowledge of industry guidance (GMP, GLP, etc).
- Experience in pharmaceutical method development, validation and transfer.
- 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.Brief Description/Overview:
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. - 2 years ago