Associate Director, Microbiology

Teva Pharmaceuticals

West Chester, PA

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JOB DETAILS

SKILLS

Analysis Skills, Asset Management, Biotech and Pharmaceutical, Budget Management, Capital Budgeting, Continuous Improvement, Documentation, Environmental Protection Agency (EPA), Equal Employment Opportunity (EEO), Establish Priorities, FDA (Food and Drug Administration), Fast Food, GMP (Good Manufacturing Practices), Government Regulations, GxP, ICH Regulations, Immunology, Industry Standards, International Operations, Laboratory, Laboratory Management, Laboratory Operations, Manufacturing/Industrial Processes, Medical Conditions, Medical Genetics, Medical Products, Medicine, Microbiology, Military, Multitasking, Neuroscience, OSHA, People Management, Pre-Clinical, Problem Solving Skills, Procedure Implementation, Productivity Management, Project Tracking, Project/Program Management, Quality Control, Regulations, Regulatory Compliance, Resource Management, Resume Search, Software Development Lifecycle (SDLC), Standard Operating Procedures (SOP), Strategic Planning, Team Lead/Manager, Technical Leadership, Test Program, Testing, United States Drug Enforcement Agency (DEA)

LOCATION

West Chester, PA

POSTED

1 day ago

**We Are Teva** We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. **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** At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.  When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.  **Already Working @TEVA?** Make sure to apply through our internal career site on Twist—your one-stop shop for career development **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.   Important notice to Employment Agencies - Please Read Carefully   Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. EOE including disability/veteran

About the Company

Teva Pharmaceuticals

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