QC Analyst / Sr. Analyst, Gene Therapy Analytical Technologies
Company: BIOMARIN
Location: Novato
Posted on: August 6, 2022
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Job Description:
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. RoleThe QC Analyst / Senior Analyst is
responsible for performing on-time release, stability, and
non-routine testing of pharmaceutical drug substances and drug
product under cGMP guidelines and procedures. The QC Analyst /
Senior Analyst is responsible for carrying out analytical method
development and troubleshooting work, executing validation and
transfer protocols, writing and reviewing protocols and reports,
supporting training to site QC, Contract Test Labs, and In Country
Testing Labs in new techniques and methods, support the preparation
of regulatory submission documents. The QC Analyst / Senior Analyst
is expected to demonstrate strong cGMP and compliance acumen. The
QC Analyst / Senior Analyst can work independently under minimal
direction while completing work assignments. This role may include
overtime and shift work.Presentation of laboratory results and
conclusions, becoming a key subject matter expert for regulatory
inspections, training and educational development of other staff
are also expected.Key Responsibilities
Keywords: BIOMARIN, Novato , QC Analyst / Sr. Analyst, Gene Therapy Analytical Technologies, Professions , Novato, California
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