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Job #02985

About our client Our client is a leading provider of contracted drug development services to the pharmaceutical industry. Their services span from pre-clinical through manufacturing, clinical, regulatory and commercial phases of drug development. Our client’s executive team are accomplished leaders in the full spectrum of drug development and have extensive experience working in and with pharmaceutical, biotech and contract services organizations. Position Location Coordinator of CMC Services, Analytical Cincinnati, Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare and/or review, file as well as maintain the analytical portion of regulatory submissions 2) Identify and assess regulatory risks associated with analytical method development 3) Prepare, review and update analytical documentation protocols, stability protocols as well as data and product-related SOPs 4) Define requirements as well as monitor analytical and bioanalytical work in support of process development experimentation 5) Coordinate/oversee technology transfer, process demonstration as well as troubleshoot and support manufacturing 6) Develop, review and execute process development analytical methods as well as technical reports to support regulatory submissions 7) Lead and/or manage all analytical method development and revision, including stability and all affiliated documentation (through FDA submission and possible approval) 8) Act as analytical testing liaison between client and/or FDA to facilitate communication of information as well as question and issues’ leads 9) Ensure completeness and accuracy of content in analytical sections of regulatory submissions 10) Prepare and deliver effective presentations for external and internal audiences 11) Build and maintain relationships with key FDA personnel in CDER, CDRM, CFSAN, etc. 12) Manage/oversee pre-formulation and formulation testing method development of drug products (liquids, semi-solids, lyophilized, IR solids, parenterals, gels and extended release products) 13) Oversee the writing of pre-formulation and formulation-related stability protocols and reports 14) Analyze and/or review results statistically (as required) 15) Oversee the writing of master batch records, compounding procedures and establish justified finished product stability and in-process specifications 16) Source contract laboratories and similar vendors in collaboration with operations 17) Ensure specifications are in place to optimize quality materials from vendors in collaboration with Regulatory and Operations Departments 18) Establish and maintain adequate records of client project information 19) Advise Operations on substandard vendor performance or work product 20) Participate actively (as needed) in quality issues to ensure efficient management, reduced production delays and improvement in quality 21) Prepare and manage project’s timing, costs and resources 22) Direct progress reports and ensure that all appropriate functional executives receive progress notifications 23) Establish and maintain relationships with industry influencers and maintain ongoing relationships with regional and national practitioners to support the organization’s product portfolio 24) Represent the company at trade associations and scientific meetings 25) Provide analytical testing, regulatory vision and leadership 26) Handle the task of delivering major tangibles in the form of analytical sections of IND, ANDA and NDA applications, amendments, supplements as well as standard reports Requirements 1) BS (Chemistry/Biochemistry or related field) 2) 6 – 9 years of pharmaceutical experience in research and/or development of analytical methods as well as characterization of materials, process transfers, method qualification and validation 3) Knowledge of cGMP requirements and regulatory affairs 4) Ability to manage multiple and diverse projects simultaneously 5) Ability to develop relationships and generate collaborations 6) Superb analytical and time-management skills 7) Strategic thinker with the ability to plan and implement 8) Excellent presentation and communication (written and verbal) skills 9) Team player with high integrity and an open interactive style with strong interpersonal skills 10) Assertive, decisive and result-oriented individual