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Manufacturing Associate, Downstream Processing

Location:Pennsylvania - United States
Salary:Highly Competitive
Reference No:US.SC.CF.10379

This Manufacturing Associate job will contribute to the Downstream Manufacturing group within the brand new state-of-the art biologics manufacturing facility located in PA, USA. Our client is seeking a highly self-motivated person willing to contribute to the development, qualification, and eventual operation and overall success of downstream operations. This is a contract position. 

Job Responsibilities:

  • Assist in developing procedures (SOP's & Master Batch Records) for the Manufacturing Downstream group.
  • Initiate and complete deviations, change controls, investigations, as assigned using TrackWise or any similar software system.
  • Compliance to safety guidelines and current Good Manufacturing Practices (cGMP).
  • Ability to train other associates and willing to be involved in cross-training in other groups, as required.
  • Assist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs such as IOQ and PQ.
  • Completes all training documentation within a defined time-frame.
  • Analyze in process samples generated from purification activities by using pH/conductivity meters, scales, spectrophotometers etc.
  • Practice a continuous improvement mindset by making suggestions on process improvements.

Essential Qualifications:

  • At minimum an Associate's degree in biology, chemistry or a related scientific or technical area.
  • 2 to 4 years of experience within cGMP manufacturing.
  • 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.
  • Excellent oral and written communication skills.
  • 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.

Desirable 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).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your CV on our website
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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