AbbVie

Scientist, Pharmaceutical Microbiology

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Jan 16, 2021
Ref
205645
Required Education
Doctorate/PHD/MD
Position 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 www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Scientist - Pharmaceutical Microbiology, working independently, 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 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.

Furthermore, 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 Allergan internal and applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

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.
• 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.
• Previous experience with proteins, biochemistry and/or biopharmaceutical characterization is considered a plus.
• 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.

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.