Scientist

Expertise and technical leadership managing instrument/method validations change requests and improvement initiatives. Lead/Manage assay qualification and validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with the functional area managers, performing statistical data analysis and final summary reports per ICH and internal guidelines. Lead investigator providing technical and analytical representation for, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making. Coordinate analytical support within QC necessary to identify root cause. Facilitate major investigations, review of change control requests, provide representation to tech transfer as needed, review of process and method validation initiatives in support of the QC laboratories in the. Provide technical expertise and support for monitoring/assessing analytical method performance, troubleshooting and assay remediation. Manage and contribute to cross functional teams to,. Lead management of the document change requests for method SOPs. Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates to meet schedules and/or resolve technical problems. Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies. Responsibilities: Project Management (5%) Technical writing-author and review of protocols, reports, data summaries, procedures, etc (25%) Lead analytical method qualification and validation studies (400%) Support with Training personnel as required (10%)Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Manufacturing Technical Service, Regulatory Affairs, and CMOs (10%).
Education and Experience Requirements: 7-10 year experience in pharmaceutical industries with focus on Chromatography/Mass-spectrometry and similar analytical instrumentation; Team leadership; Experience with analytical method validation and/or GMP investigations; Direct experience in authoring and review of CMC sections for regulatory filings; Direct experience in presenting CMC topics in regulatory inspections; Degree in Chemistry or Biological sciences. Key Skills, Abilities, and Competencies: Direct experience within GMP organizations, experience in Quality preferred; Excellent, professional interpersonal and communication skills (both verbal and written); Demonstrated ability to work effective by independently and on cross functional teams. Internal and External Contacts: Internal: QC Biological & Analytical Sciences, Quality Assurance, Validation Vendor: Waters Customer: Analytical Development, Process Development, Manufacturing, Supply Chain.

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