Associate Director, Extractables & Leachables
The Associate Director for the Extractables & Leachable (E&L) group is responsible for the day-to-day operations of the E&L group. The position reports directly to the Director of E&L.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Implement strategic business initiatives outlined by the Director with the objective of consistently producing accurate test results, maintaining clients and increasing business. Participate in the development of these strategic business initiatives.
- Ensure that client needs are met in a cost effective manner by working with the Director to manage the E&L budget.
- Interact with other groups within Boston Analytical for clients/projects requiring multiple resources to ensure effective communication and that the needs of the client/project met.
- Participate in project quote review with attention to accurate documentation of project scope, complete capture of necessary materials/supplies to deliver the project, and accurate accounting of resource effort to complete the final deliverable.
- Responsible for overall laboratory operations with attention to consistent implementation of policies, procedures and business practices.
- Develop and maintain a work schedule for the E&L group that allows for assignment of studies to the team and also allows for accurate discussions with sales and CS groups regarding potential new work.
- Responsible for direct management of the laboratory staff, with a focus on performance management and ensuring scientists are working independently.
- Ensure the attainment of company objectives through the selection, development, motivation and evaluation of lab staff. Work with the Director relating to hiring, termination, and performance management issues.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
REQUIREMENTS & QUALIFICATIONS
Qualifications include a Master’s and/or Bachelor’s degree in Chemistry or a related discipline is required with 5+ years of chemistry analytical laboratory experiences in a pharmaceutical contract laboratory environment and 3+ years’ experience managing laboratory personnel. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the current best practices, requirements, and regulations for conducting Extractables & Leachables studies on packaging and manufacturing components for all forms of drug products, as well as medical devices.
MINIMUM SKILLS REQUIREMENTS
- Ability to properly schedule the workload to meet the varying demands.
- Ability to implement appropriate strategies used in the laboratory to address market segments or business growth as outlined by the Director.
- Self-starting, motivated person who possesses strong interpersonal who is able to motivate, train and monitor the Laboratory personnel by establishing and maintaining guidelines for standards of performance.
- Delegate responsibilities to Managers and Group leaders.
- Proven ability to be an effective hands-on leader.
- Objectively evaluate the performance of others.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Analytical Chemists *All-Levels*
- Analytical Chemist III
- Associate Director, Extractables & Leachables
- Client Services Project Manager
- Client Services Project Manager Assistant
- Lab Technician - Chemistry
- Lab Technician - Microbiology
- Microbiology Manager
- Microbiologist II
- Quality Assurance Specialist
- Senior Scientist - Extractables & Leachables
- Senior Scientist - Analytical Development