Overview
Leanbio offers a dynamic role as Bioassay Quality Control Analyst within our Biopharmaceutical Contract Development and Manufacturing Organization (CDMO). We provide end-to-end services in the field of recombinant proteins, mRNA and plasmid DNA.
We have a proven track record in development and manufacturing of therapeutic molecules such as antibodies, Fab fragments, antibody-drug conjugates, enzymes, complex proteins, mRNA and plasmid DNA.
The new facility includes state-of-the-art development laboratories, outstanding quality control rooms and warehouse. Our global service provider for biologics is looking for a skilled professional to join the QC team :
Responsibilities
- Perform cell proliferation methods and other bioassays to verify the potency of biotechnology products.
- Maintain accurate records in laboratory notebooks or electronic systems.
- Participate in quality system activities including investigation of out-of-specification results.
- Maintain laboratory equipment calibration and functionality.
- Follow all biosafety and safety protocols contributing to maintaining a clean and compliant laboratory environment.
Qualifications
The ideal candidate will have advanced training in bioassays analysis with 2 to 5 years of experience in Quality Control within a GMP-regulated pharmaceutical environment.Practical expertise in bioassays used in biotechnology, including cell proliferation assay.Skilled in cell culture and knowledgeable about ALCOA++ data integrity principles and GMP documentation practices.Experienced in managing quality systems including out-of-specification investigations and change control.Proactive team player with strong organizational skills and ability to work independently.#J-18808-Ljbffr