Location: Hauppauge,NY, USA
We are looking for a Manager, Analytical Development (AD) 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.
How You Will Make An Impact:
Leading scientific development of new analytical methods and identifying opportunities for improvement on existing methods.
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).
Assessing budget and proposals and managing the purchase of laboratory equipment and supplies.
Developing training requirements, and conducting training of staff.
Write, revise or review SOP's, analytical protocols, analysis reports, specifications, and controlled forms.
Review and approve relevant laboratory documentation.
Lead qualification efforts for new and existing analytical equipment.
Maintain and expand knowledge of analytical methods development capabilities, evolving technologies, and Regulatory environment.
Assisting with preparation of development proposals, plans, project timelines, and the overall review of project activities.
Overseeing the progress and direction of laboratory investigations.
Participating in project management activities and as requested, may represent AD on project teams.
Leading client communication and scientific related project discussions as the technical manager.
Developing and achieving personal goals that align with overall business and project goals while assuring the same of any subordinate staff.
Leading development of project plans and provides leadership in support of analytical transfer activities.
Ensuring compliance with the change control policy, and other site wide programs (i.e. documentation).
Ideal Candidate Will Bring:
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.
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
Minimum of 3 years of prior leadership experience is required.
Demonstrated advanced technical knowledge of analytical methods, including strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.
Working knowledge of phase appropriate GLP/cGMP regulations, investigation processes related to lab activities and trends along with understanding of safety procedures.
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.
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.
Thorough understanding of basic chemistry, organic chemistry, chromatographic techniques and spectroscopic techniques.