Manager Analytical Development

We are looking for a <strong>Manager, Analytical Development (AD) </strong>to join the AD team. In this role you will oversee a team responsible for analytical methods development, validation, transfer, testing and reporting. You will be a technical subject matter expert, assuring compliance with regulatory (FDA, cGMP, etc.) and company guidelines while keeping project plans, timelines and budgets on track.<br><br><strong>How You Will Make An Impact:</strong><br><br><strong>Leading scientific development of new analytical methods and identifying opportunities for improvement on existing methods.</strong><br><br><strong>Supporting validation for Process Development (PD) projects inclusive of oral controlled release dosage forms, active drug substance, raw materials, preformulation support, in-process components, and supporting stability (in-house and through outside contractors).</strong><br><br><strong>Assessing budget and proposals and managing the purchase of laboratory equipment and supplies.</strong><br><br><strong>Developing training requirements, and conducting training of staff.</strong><br><br><strong>Write, revise or review SOP's, analytical protocols, analysis reports, specifications, and controlled forms.</strong><br><br><strong>Review and approve relevant laboratory documentation.</strong><br><br><strong>Lead qualification efforts for new and existing analytical equipment.</strong><br><br><strong>Maintain and expand knowledge of analytical methods development capabilities, evolving technologies, and Regulatory environment.</strong><br><br><strong>Assisting with preparation of development proposals, plans, project timelines, and the overall review of project activities.</strong><br><br><strong>Overseeing the progress and direction of laboratory investigations.</strong><br><br><strong>Participating in project management activities and as requested, may represent AD on project teams.</strong><br><br><strong>Leading client communication and scientific related project discussions as the technical manager.</strong><br><br><strong>Developing and achieving personal goals that align with overall business and project goals while assuring the same of any subordinate staff.</strong><br><br><strong>Leading development of project plans and provides leadership in support of analytical transfer activities.</strong><br><br><strong>Ensuring compliance with the change control policy, and other site wide programs (i.e. documentation).</strong><br><br><strong>? Ideal Candidate Will Bring:</strong><br><br>B.S./B.A. in chemistry or related scientific discipline (e.g., chemistry, chemical engineering, pharmacy) is required. Advanced degree (M.S. or PhD) is highly preferred.<br><br>Minimum of 10 years of relevant work experience in a pharmaceutical analytical laboratory and a minimum of 5 years of experience developing/validating test methods for pharmaceutical products across the various phases of development is required<br><br>Minimum of 3 years of prior leadership experience is required.<br><br>Demonstrated advanced technical knowledge of analytical methods, including strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.<br><br>Working knowledge of phase appropriate GLP/cGMP regulations, investigation processes related to lab activities and trends along with understanding of safety procedures.<br><br>High level of pharmaceutical and technical knowledge and awareness of the drug development process with the ability to support and coordinate projects in various stages of the development process.<br><br>Proven ability to work effectively with client and internal project team members, dealing with differing technical opinions from those clients/team members in a professional, constructive, and effective manner.<br><br>Thorough understanding of basic chemistry, organic chemistry, chromatographic techniques and spectroscopic techniques.