Job Details
We are a national staffing firm and are currently seeking a Manufacturing Associate for a prominent client of ours. This position is located in Harmans, MD. Details for the position are as follows:
Job Description:
**SHIFT: 7am-7pm on rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off, so on)**
- 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.
Qualifications:
- High School Diploma or AA/AS with GMP experince -or- BS
- Experince with SOPs/batch records preferred
- Buffer/media preparation preferred
- Nicer to Have: pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers, etc.
Compensation: Up to $29 an hour depending on experience & education
(higher level role available up to $35 for BS with extensive upstream GMP experience)