Manufacturing Associate - The Fountain Group

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 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.

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)