Associate Director, Microbiology
West Chester, United States, Pennsylvania, 19380
We Are Teva
Our Team, Your Impact
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.
How You’ll Spend Your Day
Essential Duties & 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:
o Management and implementation of relevant microbiological tests (e.g. TOC, conductivity, endotoxin, bioburden) to support routine in-process and non-routine testing.
o Management of investigations related to QC Microbiology testing and provide support to other relevant micro investigations.
o Developing and executing strategies for specialty studies (e.g. Hold Time, Low Endotoxin recovery)
o Supporting review and approval of documentation, as needed.
o Management of method suitability activities.
o Initiate, prepare, evaluate and recommend proposals for improved methods of analysis and continuous improvement initiatives.
o 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.
Additional Responsibilities / Secondary Duties:
• Participate in budget planning including capital and annual operations by proposing and executing purchases.
• Other projects and duties as required/assigned.
Your Skills and Experience
Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.
Qualifications / Education 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.)
How We’ll Take Care of You
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
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