Our client is looking for a Principal Quality Control Analyst for their Exton PA offices.
- Perform QC Biochemistry analyses of recombinant therapeutic proteins produced at the Biologics Pilot Plant.
- Execute all assay types with uniform skill, and operates most types of analytical instruments and equipment in the department following written procedures.
- Participate in assay validations and qualifications, perform biennial document reviews, and make necessary revisions to SOPs.
- Assist with training new analysts, peer-reviews other analysts’ documentation and results for completeness, and initiates and participates in laboratory investigations.
- Generate compliant laboratory data for release, assessment of stability, validation of assays, and support of process development.
- Perform assays and techniques involving HPLC, capillary electrophoresis, ELISA, qPCR, and/or other protein analytical technologies, executing all of the techniques used in the department with equal proficiency.
- Participates in assay qualifications.
- Assist with training new analysts.
- Perform biennial SOP reviews and make needed revisions.
- Peer-review documentation and results from other analysts for completeness.
- Order supplies, clean equipment, organize common areas and stocks.
- Initiate and participate in laboratory investigations.
- Provide accurate, GxP-compliant analyses of clinical biopharmaceutical products, helping to ensure timely lot release of product.
- Ensure that analytical methods are appropriately qualified or validated, ensuring smooth regulatory approvals.
- Help maintain the biochemistry laboratory systems, will train other analysts, maintain SOPs and other documents, and promote an efficient laboratory workplace.
- Minimum of 3-5 years working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
- Exhibits understanding of the principles, concepts, and practices in QC testing of biopharmaceuticals.
- Hands-on experience in HPLC, capillary electrophoresis, ELISA, and gel-based assays for analysis of recombinant proteins.
- Experience working under cGMP regulations and with ICH/FDA/EMA guidelines.
- Ability to identify and investigate assay and equipment problems.
- Fluent in English, good written and oral communication skills; good interpersonal skills.
- Team player who can excel in a “hands-on” entrepreneurial environment.
- Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
For more info on this & other exciting roles please contact me
MARC LEVINE C: 914-262-5142 E: email@example.com