$80K — $100K *
Job Description Summary:
Krystal Biotech, Inc. is seeking a Molecular Biology Scientist/Senior Scientist to perform analytical method development to support research for gene therapy products. Specific responsibilities include but are not limited to:
• Perform development for analytical methods necessary to support in-process and release testing of drug substance, drug intermediates, and drug product.
• Applies systematic, statistically driven thinking to the development of scientifically sound, well understood, and robust analytical methods. Examine scientific literature for new methods to quantitate and characterize viral vectors and process related impurities.
• Support all areas of the development process, including discovery, design, development, transfer, qualification, validation, and lifecycle management.
• Write development/technical reports documenting assay development activities.
• Coordinating internal and external analytical method transfer activities.
• Assist in project planning and execution, including experimental design, laboratory work, data analysis, interpretation of results, formulation of recommendations, and preparation of deliverables.
The ideal candidate is/has:
• Minimum of a B.S. (Biology, Biochemistry, Chemistry, or related science) with 7+ years, M.S. with 4+ years, or PhD with 2+ of relevant experience, in a biotech or pharmaceutical setting required. Advanced degrees and experience directly related to molecular biology, cell biology, gene therapy are preferred.
• Demonstrated track record of successfully developing different molecular biology analytical methods (DNA/RNA isolation, primer design, qPCR, qRT-PCR, droplet digital PCR (ddPCR).
• Strong experience in a variety of biochemical and cell-based techniques, including ELISA, Western Blotting, viral titer analysis, functional bioassays, and fluorescent imaging preferred.
• Background that includes knowledge/experience of GMP, GLP, GCP, USP, and/or ICH requirements for analytical method validation.
• Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documents preferred.
• Understanding of FDA, EMA and other regulatory agency guidance associated with release and characterization assays.
• Ability to work in a fast-paced changing environment in conjunction with cross-functional teams.
• Must be a self-starter and capable of working with minimal oversight while handling multiple projects simultaneously.
• Excellent oral and written communication skills.
• Must demonstrate proficiency in computerized systems.
Valid through: 10/26/2020
$100K — $150K
8 days ago
$80K — $100K
10 days ago