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The Manufacturing Associate III is accountable for the execution procedures for upstream manufacturing of clinical and commercial products.. Collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities.. Ability to work with bioreactor operation and cell culture including aseptic technique. " Bachelor s degree in a Scientific, Engineering or Biotech field with 4 years experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.. " HS Diploma or Associate s Degree with 5 6 years experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.

manufacturing associate

Job Title: Manufacturing Associate Job Duration: 6 MONTHS TEMP TO HIRE Job Location : Harmans MD SHIFT - 7AM - 7PM ROTATE EVERY TWO WEEKS. 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF. Description: <ul> <li> The Manufacturing Associate III is accountable for the execution procedures for upstream manufacturing of clinical and commercial products. </li> <li> Supporting areas of upstream manufacturing by using SOP s and batch records to execute pre and post processing activities. </li> <li> Lifting to 40 lbs., unassisted may be required at times. </li> <li> Frequent standing and walking is required, as this role requires presence on the manufacturing floor. </li> <li> Shift work and weekend work is required. </li> </ul> KEY RESPONSIBILITIES: <ul> <li> Collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities. </li> <li> Will lead for one or more areas in upstream manufacturing as directed by the supervisor. </li> <li> Interface with engineering group to source new production equipment. </li> <li> Interface with Quality Assurance department to execute corrective actions / preventative actions. </li> <li> Represent the department to clients and on cross-functional project teams. </li> <li> Work with manufacturing manager and supervisors to develop and maintain training materials and curricula. </li> <li> Ability to work with bioreactor operation and cell culture including aseptic technique </li> <li> Execute and monitor critical processes supporting mammalian, microbial, and fill finish production facilities </li> <li> Solid experience with the following: large-scale centrifuges, washers, autoclaves </li> <li> Performs the weighing, dispensing of raw materials for media and buffers </li> <li> Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product. </li> <li> Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc. </li> <li> Dispensing, labeling, transfer/staging of raw materials and parts </li> <li> Assembly/disassembly, cleaning and sterilization of components, parts and equipment </li> <li> Ability to contribute to the development of new concepts, techniques, and standards </li> <li> Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration </li> <li> Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps. </li> <li> Provide support to cross-functional teams to meet production or timeline demands. </li> <li> Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice. </li> <li> Adhere to Quality standards and learn and comply with regulatory requirements. </li> <li> Provide suggestions for process optimization and efficiency, where applicable. </li> <li> Operate manufacturing equipment in assigned area </li> <li> Write standard operating procedures (SOP s) and other documents as necessary </li> <li> Complete manufacturing documents such as batch records, logbooks </li> <li> Assist in the execution of validation protocols </li> <li> Ability to accurately analyzes and processes scientific data </li> <li> Ensure the completeness and accuracy of manufacturing documentation per approved procedures </li> <li> Identify and support the implementation of process efficiencies and areas for improvement </li> <li> Ensures solutions are consistent with organization's objectives </li> <li> Demonstrate ability to perform all process steps upstream and/or support production operations </li> <li> Ability to generate SOPs for equipment and procedures used in the manufacture of biological products </li> <li> Train new staff in scientific concepts, technical operations, safety, and Good Manufacturing Practice. </li> <li> Eligible to apply for the Qualified Trainer (QT) Program. </li> </ul> POSITION REQUIREMENTS: " Bachelor s degree in a Scientific, Engineering or Biotech field with 4 years experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance. OR " HS Diploma or Associate s Degree with 5 6 years experience with upstream (fermentation/bioreactor) biologic production processes under GMP compliance.

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