The Senior 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 oral, 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 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.
Location: Irvine, CA
- BS in Microbiology or a related life science and ten years of experience or MS in Microbiology or a related life science and eight years of experience
- 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 with pharmaceutical microbiology attributes such as preservative effectiveness, sterility, microbiological examination, bioburden and endotoxin is 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.
- 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, aseptic processing, and environmental control 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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.