Primary Role:
Responsibilities include, but are not limited to: Operational support including but not limited to execution, review, and approval of QC data, development of various procedures, protocols and reports. Leads and/or supports aberrant/OOT result investigations related to laboratory and process related excursions for drug substance and drug product manufacturing Method validation and transfer (Planning, authoring protocols, reports, review of qualification reports, working with development labs to address method qualification GAPS, authoring and/or reviewing SOPs) QC Analytical method troubleshooting, Method re-validation, Data trending Participation and support in any required quality systems (CAPA, deviation, change controls) or investigations Reviewing technical memos, stability data, assay controls etc Cross functional interactions to address assay related issues Coordinate QC testing of development lab studies Provide technical oversight and troubleshoot assays in contract testing labs and DS and DP manufacturers Support QC CMC activities in various ongoing filings Support instrument IOQ activities
Responsibilities:
Major responsibilities include:
Operational support including but not limited to execution, review, and approval of QC data: 60%
Method qualification review, validation and transfer activities: 10%
Technical oversight and troubleshoot assays in Shire HGT QC, contract testing labs globally, and DS and DP contract manufacturers: 10%
Support CMC activities: 10%
Cross functional interactions in QC and PAD to address assay related issues: 10%
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
Requirements:
Education & Experience Requirements:
Minimum Educ/Exp: MS with 3-7+ years of experience or BS with 6-9+ years of experience in Chemistry/Biochemistry
Key Skills and Competencies:
The candidate must demonstrate solid chemistry experience. Technical expertise in HPLC and other Biochemical methods is required. Understanding of cGMPs and quality systems Good organization skills, self-motivation, team player and knowledge of good manufacturing practices and good laboratory practices. Excellent written and oral communication skills. Good problem solving ability to address complex problems
Complexity and Problem Solving:
Good understanding of analytical methods, data analysis, and interpretation
Internal and External Contacts:
Shire HGT QC Functional Groups (Biochemistry, Cell Biology, Stability, Test Technology, Technical Services, Sample Control) Internal Shire HGT Development Labs and others (PAD, PD, CCPD, RA, QA) Shire HGT Manager, and Associate Director (Quality Control, PAD, PD, CCPD, QA, RA) Internal and Shire HGT
Other Requirements: Limited Domestic Travel Rarely and only if necessary International Travel Rarely and only if necessary
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