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Analyst or Sr. Analyst, Quality Control - Molecular Biology

Woburn, MA 01801

Posted: 05/26/2023 Employment Type: Contract Job Category: Quality Job Number: 3569

Job Description

Reporting to the Director, QC-Molecular Biology, the Analyst or Sr. Analyst - QC Molecular Biology will support the portfolio of clinical development programs to ensure timely delivery of clinical supplies.

The incumbent will specifically support the gene therapy program pipeline including but not limited to technical transfer, qualification and/or validation and routine GMP testing of AAV vector analytical methods (qPCR, ddPCR, and other methods as needed) for lot release and stability.

The Analyst or Sr. Analyst – QC Molecular Biology will prepare study protocols, SOP, study reports and support regulatory filing as needed and will be responsible for routine PCR lab maintenance and ensuring lab supplies for smooth and safe lab operation in compliance with GMP.

The Analyst or Sr. Analyst - QC Molecular Biology will assemble, review and trend GMP and stability data, generating reports as necessary to document these activities.  The incumbent will also support the development and implementation of GMP quality systems to ensure that the client is in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials by authoring appropriate SOPs and implementing training programs to support QC and related GxP processes.

o    Support the technical transfer, qualification and validation of molecular methods.
o    Perform routine GMP testings to generate characterization, release and stability data
o    Review QC data and generate stability and other technical reports as necessary
o    Prepare, analyze and trend QC data
o    Support the development of QC systems and SOPs, to enable in-house QC release testing.
o    Support QC deviations, investigations, analytical method performance trending and root cause analysis, change control and CAPA.
o    Work with cross functional teams and support regulatory filing when needed.
o    Ensure lab supplies and perform routine lab maintenance for smooth and safe lab operation in compliance with GMP 

Requirements / Qualifications:
o    BS or MS in Molecular Biology, Cell Biology, Biochemistry or a related discipline. 2+ years of relevant industry experiences preferred 
o    Familiarity and hands-on experience with DNA extraction and qPCR and/or ddPCR assays required.
o    Experience with method qualification and biologics QC is not required but preferred
o    Ability and desire to work in a fast-paced, start-up environment
o    Strong collaboration and team-working skills and be flexible.
o    Independently motivated and detail-oriented with good problem-solving ability
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