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Scientist 2 – Chemistry / Biochemist job in Malvern at Ampcus Inc.

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Scientist 2 – Chemistry / Biochemist at Ampcus Inc.

Scientist 2 – Chemistry / Biochemist

Ampcus Inc. Malvern, PA 19355, PA Full Time
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Experienced in the use of multichannel pipette, cell work, and bioassay experience is required. Preferred experience in Growth Promotion Assay, Dot Blot, ELISA, cSDS methods, and/or HPLC/UPLC.

· In a team setting and cGMP environment, perform routine analytical testing in support of release and raw material samples. Conducts routine and non-routine testing of materials and product using a variety of equipment and test methods including but not limited to: HPLC testing, protein concentration testing, nephelometry testing, ELISA, cIEF, and SDS-PAGE. Prepare data and documentation using calculators and computer software.

· Entry and review of data in a Laboratory Information Management System (LIMS).

· Peer review, evaluate and investigate results from various analyses.

· Participate in special projects such as laboratory equipment validation, analytical method transfers and SOP reviews.

· Assist and train other chemists in everyday laboratory functions.

· Properly dispose of sample preparations and solutions according to safety and environmental procedures.

· Performs qualitative and quantitative chemical analysis of in-process manufacturing materials.

Required:

· Bachelor’s Degree in Biology, Biochemistry, Microbiology, Chemistry or related field.

· 0-4 years related experience in university/college or medical device, biopharmaceutical or pharmaceutical industry.

· Advanced knowledge/experience with regulatory requirements, policies and guidelines. Significant experience with Quality Control document reviews and regulatory inspection processes.

· Advanced knowledge of Quality systems.

·  Coordinates testing responsibilities to ensure QC test support according to the needs of Manufacturing to maintain continuous process flow.

·      Functions as a team member in the QC In Process Lab to provide timely test analysis information on the status of conformance to requirements.

·   Investigates testing abnormalities and implements corrective action. Cross-trains in all testing responsibilities to ensure a fully cross-functional laboratory team environment.

·         Maintains laboratory chemical supplies to ensure an adequate supply and prevent testing delays.

·         Audits documentation, device history records, and test methods for compliance.

Recommended Skills

  • Bioassay
  • Cell Work
  • Elisa
  • Hplc/Uplc
  • Lims
  • Multichannel Pipette
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