To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03570

About our client Our client is the analytical development and manufacturing services division of a well respected global pharmaceutical company. The company's growth has outpaced the industry for a number of years and they boast both an experienced management team and a commitment to maintaining a world-class corporate culture. This is a great situation for a candidate that is pursuing a challenging opportunity with significant potential for career advancement. Position Location Associate Director, Analytical Development Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide leadership to Analytical Development groups to support timely development of a multi-source product that is manufacturable, stable, non-infringing and bioequivalent 2) Ensure timelines are communicated and adhered to throughout the analytical method development and validation lifecycle under the highest GMP requirements 3) Provide the highest quality customer service (PD, DRA, BIRI, etc.) 4) Direct analytical groups to ensure assigned projects are developed and ensure these projects are qualified and registration lots are released within the determined timelines 5) Communicate issues related to projects to senior management and strategies to the Analytical Group 6) Direct an analytical group to provide method validation reports and technical documentation in support of regulatory filings 7) Determine regulatory strategies in support of ANDA/NDA and IND filings 8) Coordinate regulatory responses to deficiency letters to support project approvals 9) Lead an Analytical Development Group by coaching management 10) Provide support to managers and section heads in their efforts to coach 11) Develop extreme potential individual contributors 12) Utilize maximizing performance tools for professional growth of the group 13) Ensure that the group and the lab complies with cGMP, SOP, FDA, DEA regulations, ICH guidelines, OSHA and safety procedures 14) Lead departmental change by being a change advocate 15) Monitor currents systems and facilitate necessary changes to increase efficiency and accuracy to achieve right the first time objectives 16) Communicate with upper management, interdepartmental and intradepartmental project teams 17) Facilitate successful project and technology transfers associated with the analytical development group’s projects 18) Audit and review procedures, processes, data and laboratory preparedness for inspections 19) Participate in FDA and customer audits Requirements 1) Ph. D. in Chemistry/Pharmaceutics/Engineering with minimum 10 years of supervisory experience in the pharmaceutical industry (or MS in Chemistry/Pharmaceutics/Engineering with 12 years of supervisory experience or BS in a scientific discipline with 14 years of supervisory experience) 2) Analytical development experience in the generics sector 3) Experience in managing analytical development staff (chemists and documentation people) 4) Demonstrated knowledge of analytical development, validation, analytical instrumentation chemistry and ability to troubleshoot complex analytical issues 5) Basic knowledge of organic/inorganic chemistry and basic understanding of toxicology 6) Demonstrated knowledge of most current FDA/ICH guidelines, national Pharmacopieias and ANDA/NDA requirements 7) Demonstrated ability to communicate with all levels of management and leadership, to build and maintain inter and intradepartmental relationships 8) Ability to direct multiple projects in a fast-moving, dynamic environment 9) Demonstrated ability to coach and mentor Managers and Section Heads 10) Ability to communicate with internal and external customers 11) Ability to work independently 12) Good mentoring ability