The main responsibility of this position is to perform routine sample analysis, develop analytical methods and validate said methods under senior staff members' supervision, in accordance with cGMP/GLP guidelines, and transfer to CMOs and/or train other staff members in the proper use of the methods. This position supports analytical requirements of product development, QA/QC, regulatory affairs, and manufacturing operations. This position will assist management in the areas designated by supervisors, such as reviewing notebooks/experimental data, trouble shooting, training personnel, and writing SOPs/test methods/protocol/reports. This position will see that all analytical equipment is maintained in compliant condition and assist coordinating equipment qualification. This position will maintain accuracy in laboratory operation, scientific data, and notebook writing.
1. Ensure high quality in analytical work and maintain accuracy in record keeping.
2. Perform routine sample analysis including stability testing.
3. Provide analytical support for formulation development.
4. Develop/improve and validate analytical method and document formal reports.
5. Transfer methods to third party contract organizations and document formal protocols/reports.
6. Coordinate laboratory equipment preventative maintenance and qualification, and maintain analytical instrumentation in compliant condition.
7. Review experiment data, notebook, protocols and reports.
8. Maintenance of safe/environmentally responsible laboratory practices.
Bachelor of Science with 5+ years of experience.
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.
- Demonstrate knowledge of analytical chemistry
- Skillful in HPLC, GC, FTIR, UV, titration and wet chemistry
- Experience in pharmaceutical method development and validation
- Ability to problem solve and trouble shoot instrument issues
- Good knowledge in cGMP/GLPBrief 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.