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Manufacturing Service Associate
Ref No.: 18-08623
Location: west Chester, Pennsylvania
Start Date: 07/16/2018
Job Description
The Manufacturing Associate will contribute to the Clinical Manufacturing group within the brand new state-of-the art Biologics Manufacturing Facility (BMF) located in West Chester, PA. We are seeking a highly self-motivated person willing to contribute to the qualification and operation and overall success of the clinical manufacturing operations.  This includes but is not limited to material weigh/dispense, medium preparation, buffer preparation, and autoclave/washer processes.  May also include cell culture activities including seed expansion, along with production reactors (up to 2000 L) and cell culture harvest and/or purification activities including column packing, column chromatography, virus removal steps, tangential flow filtration (TFF) and aseptic filling operations for client  proprietary and biosimilar biologics pipeline.
JOB RESPONSIBILITIES:
  1. Assist in developing procedures (SOP's & Master Batch Records) for the Manufacturing group.
  2. Complete assigned tasks associated with clinical manufacturing and assist in execution of operations.
  3. Ability to work independently to develop and write documentation associated with clinical manufacturing.
  4. Assist in troubleshooting equipment or process issues.
  5. Initiate and complete deviations, change controls, investigations, as assigned using TrackWise or any similar software system.
  6. Compliance to safety guidelines and current Good Manufacturing Practices (cGMP).
  7. Ability to train other associates and willing to be involved in cross-training in other groups, as required.
  8. Follow standard operating procedures.
  9. Assist in validation needs such as IOQ and PQ.
  10. Ability to multi-task and work well with the team.
  11. Completes all training documentation within a defined time-frame.
  12. Analyze in process samples generated from cell culture or purification activities by using osmometer, pH/conductivity meters, scales, spectrophotometers, Vi-cell, Nova, BGA, etc.
  13. Performs review of the manufacturing documentation of the associated area.
  14. Other duties as assigned.
  15. Practice a continuous improvement mindset by making suggestions on process improvements.
 
 
Qualifications
REQUIRED QUALIFICATIONS:
  • Associate's degree in biology, chemistry or a related scientific or technical area or 3 to 5 years of experience within cGMP manufacturing.
  • Ability to work in fast paced, dynamic environment.
  • 2+ years hands on experience within large molecule and/or clinical manufacturing.
  • Experience with medium and buffer solution preparations within a cGMP environment.
  • Strong background in aseptic technique and microbial controls.
  • Experience with process development, tech transfer and optimization a plus.
  • Strong understanding of cGMP's as applicable to biologic operations.
  • Excellent oral and written communication skills.
  • Ability to stand, walk, bend and reach for long periods of time.
  • Ability to work flexible working hours.
  • Effectively manages time and must pay attention to detail.
  • Ability to lift and push up to 30 pounds or more.
  • Must be able to read, interpret, and follow SOP's, batch documents and other procedures.
PREFERRED QUALIFICATIONS:
  • 5 or more years combined experience in cGMP manufacturing.
  • B.S. in biology or related life-sciences field.
  • Experience with process development, tech transfer and optimization a plus.
  • Experience with UNICORN software a plus.
  • Experience with cell culture/fermentation a plus.
  • Experience with process control SCADA software (e.g., WonderWare).
  • Experience with single use manufacturing systems.
  • Experience authoring controlled documents, such as SOP's and batch documents.
  • Basic knowledge of MS Office (Word, Excel, Outlook, Powerpoint).
  • Experience with TrackWise for performing change controls, deviations, etc.