QC Analyst 1

Landmark Bio

Watertown, MA

JOB DETAILS
SKILLS
Analysis Skills, Analytical Development, Cross-Functional, Current Good Manufacturing Practice (cGMP), DNA, GMP (Good Manufacturing Practices), Gene Therapy, Laboratory Analysis, Laboratory Testing, Manufacturing, Mentoring, Patient Safety, Polymerase Chain Reaction (PCR), Process Development, Process Manufacturing, Quality Assurance Methodology, Quality Control, Regulations, Team Player, Testing, Time Management
LOCATION
Watertown, MA
POSTED
12 days ago

The Quality Control -Analytics department supports a growing portfolio of cell and gene therapy (CGT)products, including CAR-T, iPSC, AAV, LVV and synthetic DNA products. We are immediately recruiting for a highly motivated QC Analyst to perform laboratory testing with distinct technical but complementary focus within a fast-paced GMP environmentYou will contribute to the development, qualification and execution of analytical methods supporting GMP release and characterization testing. Additionally, you will work cross-functionally with Analytical / Process Development, Manufacturing, and Quality Assurance to ensure methods meet regulatory and compendial expectations while supporting patient safety. This is an outstanding opportunity for a candidate to work under the guidance of a supervisor and mentor, manage time effectively, complete assigned analytical tasksin a cross-functional collaborative environment supporting development and cGMP manufacturing of cell and gene therapies. 

This role focuses on the development and optimization of UHPLC-based biophysical analytical methods and/or PCR-based, and related molecular methods supporting CGT safety, identity, puritystrength and quality testing, includingresidual impurity and compendial applications such as Mycoplasma detection.

To Apply

Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above. Your cover letter should specifically address:

  • Your hands-on experience with relevant technique

  • Any additional relevant experience

  • Your familiarity with GMP and regulatory framework applicable to CGT analytical testing. 

Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. 

About the Company

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Landmark Bio