Director, Analytical Development

Director, Analytical Development

 

Irvine Pharmaceutical Services, Inc., is a fully cGMP compliant contract testing laboratory provides expert analytical testing services for the Pharmaceutical, Biotechnology and Medical Device industries.

 

Responsibilities:

The AD Director will provide scientific leadership in analytical sciences so that short, efficient and robust analytical methods are developed for defined projects. This position requires the ability to supervise R&D department and have good problem solving abilities. Create and revise departmental and test procedures, SOP’s etc. Provide technical support in the maintenance of lab systems and instrumentation.  Works with the management group to improve and implement the required quality systems. Works closely with QA staff to maintain and improve Quality Systems. Ensure that all jobs are completed on time. Responsible for initiating OOS investigations when required. Coordinate with various departments, such as Microbiology, Quality Assurance, QC, Biopharma, Inhalation and Stability within IPS for the timely implementation of strategies to ensure objectives are properly approached and attained. Perform all assigned responsibilities within stated budgetary guidelines and policies. Achieve sales revenue and performance objectives. Requires decision-making and analysis of multiple factors in matters involving very complex issues. Demonstrated proficiency with the preparation of regulatory submissions, ability to manage multiple projects and meet critical deadlines. Demonstrated successful interdisciplinary collaboration in a team setting.

 

 Requirements:

This position requires a B.S. degree in Chemistry or a related field and at least 15+ years of pharmaceutical experience. Ph.D. preferred. The successful candidate must have bench level experience and at least 6+ years of management experience with successful tracking records. Requires excellent troubleshooting ability, communication skills and ability to present data to clients and scientific meetings. Work in a GMP environment dedicated to high quality and timely scientific results. Knowledge of GMP and regulatory issues relevant to product development (FDA, ICH, USP). Ability to meet project goals of planning, organizing and delivering effective, on-time. In-depth knowledge of a variety of analytical laboratory instrumentation and equipment: HPLC, GC, GC/MS, LC/MS, method development and method validation, etc.

 

 Skills: 

Interpersonal Skills

Time Management Skills

Oral and Written Skills at a high level

Problem Solving

Enthusiastic attitude

Organizational and detail implementation skills. 

Knowledge of the contract laboratory industry

Strong written communication and public speaking skills

Very effective people skills and negotiating ability