"Biocon - Introduction to US FDA and European Laws and Regulations (Adjunct), Henry E. Riggs School of Applied Life Sciences"

The primary responsibilities of the Adjunct Faculty member are the instruction and coordination of the Biocon Introduction to US FDA and European Laws and Regulations course for the Henry E. Riggs School of Applied Life Sciences. The Biocon-KGI program is a program in partnership with an Indian Biopharmaceutical company which has global presence in the areas of diabetes, cancer and autoimmune diseases. This program helps train recent college graduates in various areas of Drug Development, thereby making them ready to step into industry jobs. Candidates will be expected to have a strong commitment to innovative teaching and active learning. The adjunct faculty appointment is on a term-by-term basis and the course is taught via online synchronous live sessions, which take place on weekday evenings (Pacific Standard Time). The course will be taught in the spring.

This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing). Emphasis will be placed on regulatory interactions - submissions, other communications and inspections - for each product class and for each phase of the product lifecycle. By the end of this course, the students will understand the structure and function of the FDA related to the Biopharmaceutical industry. They will be prepared for entry-level professional roles in Biopharmaceutical Regulatory through instruction in Regulatory submission requirements, product modification and process change requirements and compliance documentation requirements.

Located in beautiful Claremont, California, Keck Graduate Institute is a member of the prestigious Claremont Colleges, a consortium of five undergraduate liberal arts colleges, two graduate institutions, and The Claremont Colleges Services, which provide shared institutional support services.

The successful candidate will meet the following criteria: A minimum of a Master's degree in biochemical engineering, bioengineering, or a related field, and relevant Biopharma/Biotech industry experience (5-7 years), is required. A doctoral degree is strongly preferred. Experience with downstream bioprocess technology is required. Prior teaching experience and a commitment to active learning is preferred. Experience with the Canvas learning management system and online teaching is a plus (training is available).

Essential Functions and Responsibilities: Provides high-quality student instruction. Evaluates student performance (e.g., written assignments, examinations, in-class activities); Provides remedial instruction as needed.

Required Knowledge, Skills, and Abilities: Demonstrated ability to work effectively as a member of a team and collaboratively with other departments. Excellent interpersonal and communication skills, including the ability to effectively communicate, both verbally and in writing; possess the ability to listen to all points of view, build consensus, and inform others of policies and decisions. Demonstrated ability to manage multiple tasks and adapt to changing priorities.

Physical and Mental Requirements: Ability to maintain good concentration while dealing with interruptions; attention to details with emphasis on accuracy; capable of giving, receiving, and analyzing information, formulating work plans, and articulating goals and action plans. Sitting in a normal seated position for extended periods of time. Standing for extended periods of time. Ability to hear within normal parameters. Ability to bend and stoop (e.g., to file). Ability to move about. Ability to lift and carry short distances up to 20 lbs. (e.g., to lift or move office supplies, files, books, and packages). Ability to travel locally, depending on business needs.