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Manufacturing Associate (downstream)
Ref No.: 18-04545
Location: West Chester, Pennsylvania
Position Type:Direct Placement
Start Date: 04/23/2018
REPORTS TO: Purification Manufacturing Management
The Manufacturing Associate will contribute to the Downstream Manufacturing group within the brand new state-of-the art biologics manufacturing facility located in West Chester, PA. We are seeking a highly self-motivated person willing to contribute to the development, qualification, and eventual operation and overall success of downstream operations. This includes but is not limited to column packing, column chromatography and tangential flow filtration (TFF) and aseptic filling operations for proprietary and biosimilar biologics pipeline.
JOB RESPONSIBILITIES:
  1. Assist in developing procedures (SOP's & Master Batch Records) for the Manufacturing Downstream group.
  2. Complete assigned tasks associated with Purification operations and assist in execution of operations such as column chromatography, TFF, CIP, column packing.
  3. Ability to work independently to develop and write documentation associated with Purification.
  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. Ability to lead the purification operations.
  10. Assist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs such as IOQ and PQ.
  11. Ability to multi-task and work well with the team.
  12. Completes all training documentation within a defined time-frame.
  13. Analyze in process samples generated from purification activities by using pH/conductivity meters, scales, spectrophotometers etc.
  14. Performs review of the manufacturing documentation of the associated area.
  15. Other duties as assigned.
  16. Practice a continuous improvement mindset by making suggestions on process improvements.
REQUIRED QUALIFICATIONS:
  • At minimum an Associate's degree in biology, chemistry or a related scientific or technical area or 2 to 4 years of experience within cGMP manufacturing.
  • Ability to work in fast paced, dynamic environment.
  • 3-5 years hands on experience with Purification equipment such as columns, TFF, filling.
  • Experience with buffer solution preparations within a cGMP environment.
  • Experience with TrackWise for performing change controls, deviations.
  • 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.
  • Good analytical skills to interpret and understand purification equipment and data.
  • 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 fermentation a plus.
  • Experience with process control SCADA software (e.g., WonderWare).
  • Experience with single use systems.
  • Experience authoring controlled documents, such as SOP's and batch documents.
  • Basic knowledge of MS Office (Word, Excel, Outlook, Powerpoint).