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:

• 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 SOP's 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 (SOP's) 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:
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.