Analyst, QC IV (Temporary) - United States
Want to know company name or location? Company managed [?]
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- Performs, under direct or minimal supervision qPCR, ELISA and other molecular biology analyses of test samples under cGMP to meet specified timelines.
- Works independently on assays that he/she has mastered and under direct or minimal supervision for those assays that are more complex.
- Evaluates data against defined criteria/specifications.
- Maintains laboratory supply inventories.
- Maintains mammalian and insect cell lines.
- Provides support for routine laboratory functions/chores for the QC laboratory.
- Develops and maintains proficiency in a broad range of trained test methods, mainly qPCR and ELISA. Potentially including: aseptic cell culture technique and gel electrophoresis.
- Assists in the revision of written procedures as assigned.
- Trains other analysts in mastered techniques.
- Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- Interacts with other departments, including but not limited to Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
- At least 5 years performing molecular biology techniques. Proficient in good pipetting techniques, handling micro volumes, and working with high throughput assay formats (96-well and above).
- At least 5 years in a cGMP/GLP laboratory quality control experience is preferred.
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Familiarity with use of a computer; e.g., Proficient in Windows, Microsoft Word, Excel, LIMS.
- Viral/gene therapy work experience is a plus.
- Good written, verbal, and communication skills.
- Good documentation skills.
- Demonstrates the ability to work independently.
- B.S./B.A. in a science major (biology/biochemistry/chemistry) with at least 5 years of qPCR, ELISA, and any other relevant laboratory experience.