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