Position: Manufacturing Associate III

　　Location: Harmans, MD

　　Duration: 6 + months

　　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 u pstream 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, labelling, 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 complianceManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.