Scientist

Scientist, AbbVie Inc., Irvine, CA. Design, develop, validate, and conduct microbiological experiments for pharmaceutical products of various dosage forms. Design and conduct experiments 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. Utilize experience with pharmaceutical microbiology attributes including preservative effectiveness, sterility, microbiological examination, bioburden, endotoxin, aseptic procedures, and microbiological handling of pathogenic and non-pathogenic bacterial and fungal cultures. Design experiments, risk-based approaches for product design and testing to edge-of-failure, troubleshooting, and science-driven justification of recommendations. Support the development of new pharmaceutical products by developing methods for Bioburden, Sterility, APET, BET, Microscopy and establishing control strategies for microbial growth and control. Conduct and report outcomes of special projects to achieve relevant objectives for R&D programs and projects. Design and implement micro qualification testing for ophthalmic products in special multi-dose preservative-free containers. Biofilm development and evaluation on pharmaceutical product surfaces using tools like confocal microscopy. Comply with US Pharmacopeia, Ph Eur, cGMP to ensure the quality of medicines and their ingredients, and to protect the safety of patients. Assist with the training and transfer of methods to other groups within AbbVie and to other outsourced facilities. Address deviations and OOS/OOT data through QMS. Write SOPs and conducts investigations to address deviations and OOS/OOT data through QMS. Work with medical devices, biofilm evaluation, and employing biofilm control strategies on surfaces of pharmaceutical products. Attend product development teams & address microbiological attributes. Utilize knowledge in protein & biopharmaceutical characterization, microbiological aspects of sterilization & aseptic processing & their validation. Prepare microbiology sections using proper scientific justification in Regulatory submissions & assist in writing responses to microbiological queries post submission. Maintain a productive & collaborative laboratory environment consistent with Regulatory & company expectations.

Must possess a PhD degree or foreign academic equivalent in Microbiology, Nanoscience or a highly related field of study with at least 2 years of experience in the following: (i) Experience with pharmaceutical microbiology attributes including preservative effectiveness, sterility, microbiological examination, bioburden, endotoxin, aseptic procedures, & microbiological handling of pathogenic & non-pathogenic bacterial & fungal cultures; (ii) Designing experiments, risk-based approaches for product design & testing to edge-of-failure, troubleshooting, & science-driven justification of recommendations; (iii) working with medical devices, biofilm evaluation, & employing biofilm control strategies on surfaces of pharmaceutical products; (iv) utilizing knowledge in protein and biopharmaceutical characterization, microbiological aspects of sterilization and aseptic processing & their validation.