DIRECTOR, AR&D

PRIMARY PURPOSE:

Formulated Solutions is looking for an AR&D Director to actively, collaboratively and professionally lead the Analytical Research and Development (AR&D) laboratory to drive efficiency and effectiveness while cultivating an innovative culture with technical excellence in execution. The selected candidate will lead the department and will assign, direct and manage new AR&D projects, while also establishing and implementing a strategy consistent with Formulated Solutions' defined business plan. This role will also be leading the review and trending of data associated with laboratory investigations, test method execution, method validation protocol execution, and investigation of OOS/OOT results. This individual must have extensive cGMP experience in pharmaceutical laboratory and manufacturing operations, and be able to provide leadership and mentoring to lab personnel. Additionally, this individual must have direct expertise and thorough understanding of Good Laboratory Practices, Good Documentation Practices, Analytical Method Development & Validation, transfer of robust test methods to QC, interpreting & analyzing data/trends, and excellent technical writing skills (protocols, reports, customer memos, SOPs, lab investigations, etc.).

MAJOR DUTIES AND RESPONSIBILITIES:

• Leads and manages all analytical aspects of new product development projects (e.g., method development, method validation, method transfer, regulatory compliance & submissions, laboratory investigations, approval of reports, protocols, etc.)
• Represents the AR&D department and works cross-functionally to drive on-time, right-first-time, and technical excellence in execution
• Establishes and implements strategy consistent with defined business plan
• Optimizes laboratory processes, business processes, and write/revise procedures (SOPs, work instructions, test methods, training programs, etc.)
• Interacts and collaborates directly with Quality Assurance & Quality Control to lead, review and trend laboratory investigations from aberrant data, system suitability failures, method/ protocol deviations and OOS/OOT results, and implement CAPAs and drive continuous improvement initiatives
• Provides technical support and excellent customer service to internal and external customers
• Trains, coaches, and manages the AR&D Team
• Provides support for design and maintenance of Quality Training Program in the analytical lab
• Works directly with Project Management to ensure timely completion of AR&D Projects
• Supports the analytical development efforts of multiple projects and performs review and interpretation of data and review of reports to ensure technical excellence and compliance with appropriate regulatory standards
• Coordinates and manages method transfer and qualification activities to ensure timely completion of designated projects
• Creates, reviews and approves laboratory SOPs, method validation protocols, development reports, validation reports and other technical documents
• Oversees all method development, validation and documentation activities for new product launches and regulatory submissions
• Other applicable duties, as assigned and as deemed necessary by management.

QUALIFICATIONS:

Required

• Excellent leadership skills and ability to build an engaging and collaborative culture
• Proficient with validation of analytical instrumentation such as HPLC, GC, UPLC, UV-Vis, FTIR, Viscometer, Karl Fischer, AA, ICP, Particle Size, etc.
• Extensive experience with Waters Empowers 3 CDS for data acquisition, data review, custom calculations and report generation
• Excellent project and time management skills
• Able to lead OOS, perform root cause analysis and implement corrective actions in timely manner
• Knowledge of current regulatory/compendial (i.e. USP/NF, EP, BP, JP, etc) testing requirements
• Working knowledge of FDA and ICH regulations for drug products, medical devices, cosmetics and consumer products
• Ability to use a personal computer and peripheral equipment to accurately enter, review and analyze data and produce reports
• Proficient with Microsoft Office (Word, PowerPoint, Excel) and LIMS software applications
• Knowledge of chemical safety and protective equipment
• Knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, FTIR, HPLC/UPLC, GC, AA, ICP, Particle size analysis, etc.
• Ability to establish priorities, work independently, collaboratively and productively, and proceed with objectives without supervision
• Ability to handle and resolve recurring problems
• Communicate with all levels of the organization, verbally and in writing, clearly and concisely
• Ability to work in a dynamic, fast-paced environment
• Must be able to lift up to 15 pounds.

EDUCATION AND TRAINING:

• Minimum of a Bachelor's degree in Chemistry or appropriate scientific discipline.
• Must have a minimum of 10 years experience in an analytical laboratory in an FDA-regulated industry, with at least 5 years of lab management and direct people leadership.