BioMarin 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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’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 BioMarin’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.
The QC Associate I will be part of the Assay Support group within the Quality Control department for both small molecule and bio-pharmaceutical products. The candidate will develop methods, transfer and validate methods coming into Quality Control as well as troubleshoot and optimize assays.
The candidate will also include training QC analysts on methods as well as supporting testing for special studies such as process optimization, process qualification, and deviation investigations. Strong problem solving and communication skills (written and verbal) are essential.
This position requires thorough theoretical knowledge and experience with applicable analytical methods. Activities will include defining and executing scientific plans, processing analytical data, and working with other scientists and team members.
This position offers significant opportunity to develop scientific and cross-functional skills in a biotechnology environment. The selected candidate will work in a creative, fast-paced environment, interacting with scientists or individuals from diversified backgrounds. We are looking for a team player with a record of contribution to process optimization/validation and excellent interpersonal and critical thinking skills.
Develop, optimize, validate, and troubleshoot assays.
Provide technical expertise and training to QC Analysts.
Perform biochemical/chemical analyses of samples to support process development, manufacturing investigations, and assay validation samples under cGMP to meet specified timelines.
Prepare protocols, summaries and reports for routine and non-routine studies and analytical method validations.
Draft written QC test method SOPs for new assay methods.
Maintain the laboratory in an inspection ready state.
Interface with contract facilities and other BioMarin departments as necessary.
B.S./B.A. in science (majors: biology, biochemistry, chemistry or similar) with at least 8years’ experience in a relevant functional area, documentation of specialized training relevant to the position, and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies. M.S. with at least 4 years of experience in a relevant functional area and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
Familiarity with a wide range of analytical technologies such as HPLC, ELISA, enzymatic kinetics, and/or potency assays.
Experience in method development, optimization, qualification, validation, and transfer.
Experience in cGMP laboratory; quality control experiencepreferred.
Demonstrated ability to work independently, managing projects, and meeting timelines.
Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad or JMP).
Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
Experienced with molecular biology and analytical methodologies and a variety of analytical instrumentation; capable of troubleshooting when instruments are not performing as expected. Preferredexperience with many of the following: Empower, Chromeleon, ChemStation, BiaCore, Softmax Pro.