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Scientist, Pharmaceutical Microbiology

AbbVie, Inc
Orange County, California, US
Closing date
Dec 16, 2021

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Academic / Research, Consultancy/Private Sector
Conservation science
Salary Type
Employment Type
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Pharmaceutical Microbiology Key Responsibilities: Working independently the Scientist - Pharmaceutical Microbiology, performs a variety of experiments to develop, optimize, validate, and execute test methods for evaluation of the efficacy and safety of microbiological attributes for ophthalmic, dermatological, and parenteral products, for small molecule drugs, biologics, medical devices, their raw materials and components. He/she conducts and reports outcomes of special projects to achieve relevant objectives for R&D programs and projects. He/she assists with the training and transfer of methods to other groups within AbbVie and to other outsourced facilities. He/she oversees method validation and routine tests being conducted at contract research organizations. He/she writes SOPs and conducts investigations to address deviations and OOS/OOT data through QMS. He/she attends product development teams and addresses microbiological attributes. He/she prepares microbiology sections using proper scientific justification in Regulatory submissions and assists in writing responses to microbiological queries post submission. He/she maintains a productive and collaborative laboratory environment consistent with Regulatory and company expectations. The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. Qualifications Qualifications: Ph.D. in Microbiology or a related life science and two years of post-doctoral experience or two years of pharmaceutical and/or industrial microbiology experience is required. Demonstrates a deep understanding of microbiological theories, concepts and principles. Experience in wide range of microbiological techniques including handling of bacterial and fungal cultures, aseptic procedures, and microbiology-related experimentation are required. Experience in attending propduct development teams to address microbiological attributes. Design of experiments, risk-based approaches for product design, testing to edge-of-failure, trouble shooting, and science-driven justification of recommendations are integral to the job function. Experience with pharmaceutical microbiology attributes such as preservative effectiveness, sterility, microbiological examination, bioburden and endotoxin is highly desirable. Articulates ideas in a clear, concise and persuasive manner both orally and via written communication to generate presentations, reports, guidelines, protocols and memos as necessary. Knowledge on the microbiological aspects of sterilization and aseptic processing and their validation will be considered a plus. Self-motivated and shows willingness to take on new approaches/technologies and additional responsibilities. Must be able to work independently with minimum supervision. Must possess good interpersonal skills, the ability to work in a dynamic team environment and must multi-task to meet project timelines. Key Leadership Competencies: Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance. Learns fast, grasps the "essence" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and enables innovation to reality. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.


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