QC Analyst - 4 Cycle Shift
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
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.
QC Analyst - InProcess Control (Shift Role)
Role Responsibilities
- Performprimary review of QC raw dataand trend results
- Prepareprotocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies
- Draft and updateQC Standard Operating Procedures (SOPs)
- Act as atechnical subject matter expert (SME)and provide training and support to other analysts in areas of expertise
- Evaluate analytical and microbiological results against definedacceptance criteria
- Conduct and documentlaboratory investigationsthrough to completion
- Maintain the laboratory in aconstant state of audit and inspection readiness
- Interact directly withregulatory agency inspectorsduring audits and inspections
- Interface with other BioMarin functions includingManufacturing, Quality Assurance, Facilities, and external contractors as required
- Other duties as assigned
Desirable Skills and Attributes
- Excellentwritten and verbal communicationskills
- Strongcustomer focus, with personal accountability for speed, quality, and accuracy of delivery
- Selfmotivated, with the ability towork under pressurein a fastpaced environment
- Teamoriented, with active participation inteam development and continuous improvement, including standard work and 5S
- Demonstrated success in achieving goals as part of ahighperforming teamin a growing organisation
- Provenadaptability and flexibilityto support an evolving operational environment
Education and Experience
- BScin a scientific or engineering discipline with5+ yearsof relevantcGMP laboratory experience
or - MScwith3+ yearsof relevantcGMP laboratory experience
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
