Manufacturing Associate - DSP- PR Protein Sciences
Responsibilities: Primary responsibility will be execution of SOPs and Batch Records in the downstream department in the cGMP manufacturing of recombinant proteins. Duties will include executing techniques such as column packing and chromatography, depth filtration and tangential flow filtration. Secondary responsibilities will be writing, updating and reviewing cGMP documents including SOPs, batch records, calibration records and validation protocols. Tertiary responsibilities will be assisting in the execution of SOPs and Batch Records in the cell culture area of the the cGMP facility.
? All manufacturing employees are responsible for training on, understanding, and following documented procedures which apply to their department that support the Quality System.
? All manufacturing employees are responsible for maintaining records and documentation in accordance with a cGMP environment.
? All manufacturing employees participate in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
? All manufacturing employees assist in the flow of materials and equipment in and out of the cGMP facility.
?Education: Minimum BS/BA in a related science (e.g. Biology, Chemistry,
Biochemistry, Bio-processing or Biotechnology)
? Minimum three to five years experience in cGMP downstream bio-processing
?Experience in writing, updating and reviewing cGMP documents
?Willing to work changing work schedule
?Good communication and social skills
||Pearl River, NY |