Pharmaceutical Clinical Associates, LLC
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Raritan ,
NJ
ESSENTIAL DUTIES AND RESPONSIILITIES:
Perform complex analyses related to protein/glycoprotein characterization. Develop new methods and optimize existing methodology to address analytical challenges related to current standards of “Well-Characterized Proteins”. Lead method development through validation and eventual transfer to QC. Apply acceptable cGMP practices during execution of all applicable work tasks. Work independently with minimal supervision.
1. Perform complex analyses of test articles by appropriate protein characterization methods.
2. Develop new and optimize existing methods with guidance. Compile/analyze data. Write SOPs.
3. Conduct test method validation. Assist with eventual technology transfer to QC. Write validation protocols/reports with guidance.
4. Demonstrate initiative to assure completion of all routine and non-routine responsibilities.
5. Apply acceptable cGMP practices during execution of applicable work tasks.
6. Actively and effectively: Engage in teamwork, Communicate, and Collaborate within and outside the department.
7. Use scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problem resolution. Suggest process improvements to dept. management.
8. Work independently with minimal supervisory guidance.
9. Update Management of progress at least weekly. Seek guidance as needed.
Experience and Skills:
1. B.S., M.S. or Ph.D. in relevant science such as Biochemistry, Chemistry, or Biology.
2. B.S. (3-7 yr.), M.S. (0-5 yr), Ph.D. (0-3 yr) of experience in state-of-the-art analytical techniques relevant to protein/glycoprotein characterization (e.g. HPLC, Electrophoresis, Mass Spectrometry).
3. Significant hands-on experience and thorough working knowledge of Capillary Electrophoresis is a strong plus.
4. Experience in the characterization and comparability studies of therapeutic monoclonal antibodies is preferred.
5. Experience in the Biopharmaceutical industry, methods validation and technology transfer is preferred.
6. Experience in a cGMP environment and a working knowledge of cGMP regulations is preferred.
7. Excellent teamwork and communication skills. Attentive to detail. Good computer skills.
8. Ability to work independently, perform complex troubleshooting of instruments and methods, and develop/validate methods with minimal supervision.
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience: At least 5 Years
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan , NJ
Raritan , New Jersey
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