Research/Manufacturing Associate - PCR
Mesa Biotech is a fast growing, ISO certified, FDA cleared, medical device company that has achieved a dramatic simplification in the complexity of DNA and RNA molecular testing. Our patented technology provides everything needed to conduct rapid molecular tests at the point-of-care. The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere, from the physician’s office to the patient’s home.
We are seeking a motivated and independent molecular biology Research/Manufacturing Associate to support the development of point-of-care molecular diagnostic kits in a demanding, fast-paced environment.
The successful candidate will work closely with other scientists to develop and validate sample preparation methods as well as aid in the optimization of amplification methodologies.
Additional duties may include device testing and verification as well as aiding in the QC process. Attention to detail and the ability to write and follow SOPs is critical.
The ideal candidate will have demonstrated biochemistry and molecular biology expertise and experience with PCR and RT-PCR technology.
Experience working with infectious agents in a BSL-2 environment is desired.
- Must have direct knowledge and experience of PCR, RT-PCR, DNA sequencing, and formulation of IVD diagnostic products.
- Hands-on experience with PCR assay development and optimization
- Isolation of nucleic acids from a variety of sources
- Direct knowledge of dilution and analytical processes utilized in the manufacture of enzyme solutions.
- Ability to work in a multidisciplinary team environment
- Good communication skills
- Excellent team working and communication skill
- Hands on experience with handling BSL-2 pathogens
- Able to fill out batch records and follow cGMP compliance.
- Testing activities including quality control tasks to determine bead and/or strip suitability.
- Make solutions, formulate assays using volumetric solutions
- Use balances, pipetting equipment, spectrophotometric and pH instruments to make and test solutions.
- Work directly with QA personnel to insure the components meet or exceed product specifications.
- Maintain and set-up documentation and control procedures that meet or exceed ISO 13485 and FDA requirements.
- Develop SOPs, specifications, IQ/OQ/PQ, calibration, and preventative maintenance documents.
- 2+ years previous Biochemistry or Molecular Biology experience and Industrial or CLIA laboratory experience
- Bachelor’s in Biology, or related field
We offer a competitive salary, comprehensive benefits including: medical, dental, vision, flex plan, life/disability insurance, 10-paid holidays, 15-days PTO and a 401(k) plan.
If you like the start-up environment, have a problem driven mindset, want autonomy working for an innovative company; get ready to roll-up your sleeves and join our team of collaborative people!