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Analytical technology transfer specialist
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Pharmaceutical industry today.
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Analytical technology transfer specialist : MedImmune
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| Job Number |
57539 |
| Employee Type |
Full Time |
| Company Name |
MedImmune |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
6 to 9 Years |
| Start Date |
1/25/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Science |
| Relocation |
Not Required |
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MedImmune
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| Description |
Basic Qualification
•At least a bachelor’s degree in biochemistry or analytical chemistry plus a minimum of 6 years experience in the biopharmaceutical industry;
•Candidate must have a strong working knowledge in a biopharmaceutical quality control or development laboratory environment with experience in associated analytical methods (SDS-PAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay);
•Work experience in method validation, technology transfer and stability testing.
Details
•Contribute to the successful and timely transfer of BioPharm analytical technologies to and from various R&D departments, GSK commercial manufacturing organizations or contract manufacturers’ testing labs;
•Own and manage method life cycles, apply appropriate statistical tools to assess assay capability, and develop method qualification/validation strategies consistent with ICH requirements and current regulatory expectations;
•Author and coordinate the execution of qualification and validation protocols;
•Administer the critical reagents/reference standard inventory program and supports the effective transfer of analytical methods to and from sites;
•Assume responsibility for writing and reviewing SOPs, protocols, and other laboratory documentation as necessary;
•Contribute to product specification development and ensure alignment with process/method capabilities;
•Strong technical writing abilities and in depth knowledge of cGMPs, biopharmaceutical manufacturing processes, validation processes, and analytical methods is required;
•Work closely within and across interdepartmental matrix teams to ensure harmonization of release, stability and technology transfer testing practices;
•Collaborate with GSK analytical development groups and serve as a liaison on technical issues with secondary customers;
•Work with QA, document control and validation groups to ensure quality standards are maintained and/ or enhanced;
•Travel, including international travel, will be required. |
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| Requirements |
Preferred Qualification
•At least a bachelor’s degree in biochemistry or analytical chemistry plus a minimum of 6 years experience in the biopharmaceutical industry. Ph.D. degree preferred;
•Candidate must have a strong working knowledge in a biopharmaceutical quality control or development laboratory environment with experience in associated analytical methods (SDS-PAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay);
•Work experience in method validation, technology transfer and stability testing;
•Cold chain distribution and other logistics experience are highly desirable.
•Strong project management skills;
•Strong familiarity with FDA/EU/ICH and ROW regulations and guidance.
•Self motivated;
•Excellent communication skill, ability to interact with both internal and external parties;
•Ability to work both independently and within a team environment;
•Second language is a plus. |
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