Manufacturing Assoc. I
GENERAL SUMMARY OF POSITION:
Manufactures, assembles, and labels clinical and commercial biologic products. Operates manual and semi-automatic, and automated production equipment. Performs all functions under the cGMP guidelines.
•MAJOR RESPONSIBILITIES:Perform manufacturing activities for a variety of licensed and clinical and commercial products which may include bioreactor operation, purification, filling, packaging and labeling
•Perform manufacturing activities of licensed and clinical products in an aseptic environment
•Perform autoclaving, cleaning and sterilizationoperations as needed
•Maintain records and logbooks
•Assist in the tabulation of data and report generation
•Serve as backup for routine EM activities
•Assist in the training of manufacturing technicians
•Prepare media and buffers and maintains the corresponding batch and solution records
•Perform visual inspection of final product vials
•Perform additional job related duties as required
•Bachelor’s degree in a scientific discipline, preferably biology; or equivalent.
•0-2 years of relevant experience.
•Ability to follow instructions precisely, recognize deviations, and recommend corrective action within scope of training.
•Ability to adapt to a cGxP regulated environment.
•Ability to troubleshoot within scope of training.
•Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
•Strong time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines.
•Ability to apply scientific and technical principles to problem solving.
Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
•Excellent written and verbal communication skills. Ability to communicate effectively with others.
•Ability to work effectively both independently and as a member of a team.
•No travel required, standard work hours may require weekend and off shift hours as required
•Must be able to lift 50 lbs minimum using proper lifting technique
•Experience in the following areas is preferred: aseptic practices
•Experience in the following areas is preferred: manufacturing
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