Christopher Kegan Cala Email & Phone Number

Greater Chicago Area

-Involved in all stages of product development for parenteral formulations (feasibility stage through product launch).-Plan, develop, and implement formulation and developmental studies, following GMP requirements. Evaluate and interpret test results; develop alternate courses of action when needed to achieve desired goals.-Provide technical service and product information for the support of manufacturing, quality assurance, medical information, and marketing.-Identify critical process parameters and process controls for scale up of manufacturing process and transfer knowledge accurately to the manufacturing plant.-Write Chemistry, Manufacturing and Control (CMC) documents for Regulatory submission and FDA communication letters.

Greater Chicago Area

Thousand Oaks, Ca

-Applying fundamental protein chemistry and engineering principles in identifying and resolving issues related to protein formulation and development.-Designed and executed studies to evaluate the stability of protein formulation for drug substances and drug products.-Supported a late stage protein drug product process development group in process characterization studies for unit operations including: freeze/thaw, mixing, filtration, filling and stoppering.-Examined individual unit operations and optimized processes, assessing the impact on product quality from various stages of the manufacturing process, and report findings.-Authored and data verified documentation, technical reports, technical assessments, GMP documentation, and regulatory filings.-Experience operating and troubleshooting HPLC with working knowledge of Chromeleon for HPLC.-Proficient project management skills, multi-tasking, and ability to elevate relevant issues to project or supervisory lead.-Able to learn new techniques and concepts independently and by recruiting the expertise of others.-Participated in global cross-functional teams and work effectively in a highly matrixed team environment.

Camarillo, Ca

-Comply with GMPs, adhere to SOPs and use aseptic technique to manufacture buffers and enrichment media.-Supervision and training of other employees during manufacturing, hands-on tasks, and critical processes.-Drafting and revision of documents, and review of documentation.-Report and investigate problems.

Department Of Atmospheric And Oceanic Sciences

-Work both individually and collectively with others to prepare and execute experiments.-Meticulous collection and subsequent analysis of data.-Work with a fluorescent spectrophotometer to determine hydroxyl radical formation.-Work with a liquid waveguide capillary cell instrument to determine iron formation.