Associate Director, Microbiology

Teva Pharmaceuticals•West Chester, IA

18d

About The Position

This position requires knowledge, experience and skills to manage a group for quality control operations, focusing on microbiological testing and corresponding investigations within a GxP-compliant laboratory to support the manufacture of pre-clinical and clinical product(s) as well as supporting the transition of testing programs to Teva Global Operations (TGO) upon commercialization. Primary activities center on being able to adapt departmental plans and expertise to implement and manage state-of-the-art microbiological equipment and methods (i.e. evaluate, initiate, execute and manage transfer and validation). Additional responsibilities include providing technical guidance to employees, colleagues and/or customers. Assessing, improving and maintaining local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position. The position requires demonstrated application of standard principles, theories, and techniques to solve specific problems in a productive manner and the ability to manage multiple projects.

Requirements

BS/MS/PhD with 10+ years’ experience in Microbiology within the pharmaceutical industry
7+ years’ experience in laboratory management
4+ years’ of supervisory experience
Strong microbiology background (regulations, expectations, GMPs, Manufacturing processes, etc.)

Responsibilities

Maintain up to date knowledge of and compliance with government regulations (e.g., FDA, EMA, MHRA, OSHA, DEA, etc.), industry standards (e.g., WHO, ICH guidance) and Teva policies and procedures.
Identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols and reports, including performing Corporate Gap Assessments and Periodic reviews.
Supervise resources and assets that include a small team and multiple simultaneous projects.
Provide oversight of and/or manage QC microbiology laboratory operations, including but not limited to: Management and implementation of relevant microbiological tests (e.g. TOC, conductivity, endotoxin, bioburden) to support routine in-process and non-routine testing.
Management of investigations related to QC Microbiology testing and provide support to other relevant micro investigations.
Developing and executing strategies for specialty studies (e.g. Hold Time, Low Endotoxin recovery).
Supporting review and approval of documentation, as needed.
Management of method suitability activities.
Initiate, prepare, evaluate and recommend proposals for improved methods of analysis and continuous improvement initiatives.
Equipment and instrument management (e.g. qualification, implementation, maintenance, retirement, etc.) in accordance with the governing SDLC procedures and regulations.
Develop staff by ensuring their skills and motivations suit their roles and responsibilities, as well as providing appropriate growth opportunities to maintain/increase expertise in Quality Control work activities which will improve productivity and efficiency of the department operations.
Participate in budget planning including capital and annual operations by proposing and executing purchases.
Other projects and duties as required/assigned.