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Analytical Chemist I
Ref No.: 18-05529
Location: Andover, Massachusetts
Job Description: Analytical scientist to be a part of the quality control analytical group to support method validation projects within Pharmaceutical's polysaccharide vaccine portfolio. This candidate will be responsible for executing or facilitating method validation gap assessments through collaboration with laboratory subject matter experts (SMEs) at multiple departments/sites in Pharmaceutical, as well as performing laboratory studies for the remediation of validation gaps. Clear communication skills will be a key element to the success of this position.

The positon is at Pharmaceutical, Andover, MA.


Key Responsibilities

• Facilitating, proposing and/or performing analytical method validation gap assessments through collaboration with SMEs
• Author and review findings from the assessments into reports utilizing a supplied format
• Support gap remediation work in the form of executing laboratory validation test plans/protocols when required per remediation plans
• Provide input to SOPs, validation protocols and reports


Requirements

• BS/MS degree in chemistry, biochemistry, biology or related discipline
• Proficiency in standard bioanalytical techniques such as HPLC (SEC, IEX, RP) and UV-Vis spectroscopy is highly preferred
• Experienced in authoring technical reports, documents and/or professional journal articles
• Prior biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance... etc.), as well as familiarity of cGMPs, FDA and other regulatory guidelines (ICH, USP, EP) as it pertains to analytical method validation, is preferred but not required
• Ability to work in a team setting is a must as a high degree of interdepartmental collaboration will be required
• Proficiency in Microsoft Office (Excel functions, Word and PowerPoint)
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