Technical Lead, Analytical Sciences #job

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Matthew Masterson
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Technical Lead, Analytical Sciences #job

Job Summary & Responsibilities

The Technical Lead, Analytical Sciences will contribute to, manage, and/or oversee all aspects of analytical sciences in support of pharmaceutical development from pre-clinical through Phase III.

Job Responsibilities

•Manage the development, qualification/validation of phase-appropriate analytical methods to support Drug substance(DS) and Drug Product (DP) manufacture, characterization, controls, reference standards, stability, excipients, formulations and specification development

•Provide guidance for improvements to existing methods and/or alternate methods as needed, with applicable requirements for validation

•Oversee analytical activities while establishing collaborative working relationships with product and process development groups at contract chemical, formulation and analytical laboratories to ensure consistency of analytical methodologies throughout drug development process

•Critically evaluate and interpret experimental data received from contract organizations to make meaningful conclusions/suggestions/resolutions

•Review technical reports, and analytical methods in support of regulatory submissions, method validations, site qualifications, memos, and investigations

•Represents Analytical Sciences on cross functional drug development teams, executes team decisions in a timely manner and provides analytical advise/expertise to the teams

•Prioritizes or seeks prioritization guidance in order to manage and meet the changing needs of multiple projects

•Review bioanalytical data in support of pre-clinical studies

•Ensures completion of raw material, in-process, finished product, process validation, cleaning validation and stability product testing

•Manage stability programs for multiple projects

•Author RFP documents and subsequently provide summaries and recommendations based on responses received

•Provide analytical technical expertise to assist in audit and facility readiness activities for contract facilities

Job Specifications

•M.S. or higher in Analytical Chemistry or related discipline (other degrees will be considered with corresponding amount and applicability of experience)

•Minimum of 5 years relevant experience (development and application of analytical methods)

Knowledge, Skills, and Abilities

•Extensive knowledge of current analytical/bioanalytical methodologies (HPLC and varied detections systems, UPLC, LC/MS, LS/MS-MS, GC/MS, IVRT, FTIR, NIR, plasma extraction and other methodologies used to determine potency, purity, impurities/related substances, and characterization for impurities and related substances)

•Thorough knowledge of US and international regulatory requirements (ICH Quality Guidelines)

•Thorough knowledge of GLPs and GMPs as they relate to analytical support

•Project management and strong team leadership skills

•Demonstrated ability to work on multiple projects and meet timelines

•Innovative self-starter with the ability to work effectively within internal and external organizations and environments

•Excellent verbal and written communication skills

•Ability to adapt and manage change

Terms and Conditions

IPM is an Equal Employment Opportunity employer. Job location: PA or MD. Can be home based.

Apply online: Lead, Analytical Sciences