Manufacturing Associate III/Bio-Processing Industry

MANUFACTURING ASSOCIATE III - Bloomington, Indiana

REQUIRED: Upstream and Downstream with chromatography and other cell growth experience.Manufacturing Associate 2 or have equivalent experience in the bio-processing industry

Position Summary:  Has total understanding of cGMP and outstanding bio-technical skills for bio-process manufacturing. Can work independently on all unit operations in the bio-processing facility. Capable of filling in for the supervisor.

 

Primary Responsibilities: (will include other duties as needed)To expertly execute procedures of cell culture manufacturing and/or harvest and purification using SOP’s and batch recordsTo precisely operate and troubleshoot  equipment and techniques related to mammalian cell culture and/or harvest and purification.Is the lead operator on the process unit operating in cell culture and/or harvest and purification.Trains peers on all area unit operations and assists the Training Dept with course developmentLeads validation and qualification activitiesTroubleshoot equipment problems and recommends solutionsWrites batch records, SOP’s and Exception ReportsWill require flexible schedule to work 12 hour shifts day or night, weekends or holidays

 

Essential Skills and Experience: 

·  Must have been Manufacturing Associate 2 or have equivalent experience in the bio-processing industry

·  Must have a high school diploma or equivalent

·  Course work in related pharmaceutical manufacturing is preferred

·  Physically capable of standing for 6 hours, stooping, kneeling, climbing, good eye and hand coordination

·  Demonstrate high ethical standards

·  Strong leadership qualities

·  Recognized authority (by peers, management and technical support groups) in several process related skills