Analyst, QC I

Location:  Novato, California Category: Quality Employment Category: Fulltime-Temporary

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. 
 
 

Duties


******* This position may require weekend work due to the existing shift structure (4x10)********


Key Responsibilities



    • Adhere and follow cGMPs guidelines and procedures at all times. Escalate non-compliance concerns to management.

    • Monitor lab equipment for Calibration needs, monitoring and tracking of issues related to instrumentation.

    • Support the scheduled testing by ensuring the required reagents and glassware are stocked appropriately.

    • Maintain the laboratory in an inspection-ready state

    • Perform Analytical testing incl: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell based Bioassays, qPCR, etc.

    • Testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. in a cGMP environment.

    • Assist with preparation of protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies

    • Develop, optimize, validate and troubleshoot analytical test methods

    • Act as technical resource (SME) and train other analysts in areas of expertise

    • Evaluate results against defined acceptance criteria

    • Conduct and document laboratory investigations and deviations to completion

    • Support sample and record management for testing within the group and at CRO/CTO’s

    • Manage shipment of materials and samples to other BioMarin sites, CRO/CTO’s, or to in-country testing labs

    • Interact directly with regulatory agency inspectors during audits

    • Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary

    • Other duties as assigned


 

Skills



    • Relevant experience in a Quality Control function at an Analyst or technician level is highly preferred.

    • Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is preferred.

    • Basic understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics is preferred.

    • Demonstrated experience with passaging cells and cell-based methods is highly preferred. Experience with PCR and molecular biology methodologies is preferred.

    • Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.

    • Excellent written and verbal communication skills is required.

    • Experience in analytical data systems is preferred.

    • Accuracy and attention to detail is required.

    • Excellent cross-functional team participation skills.

    • Basic problem-solving abilities.

    • Ability to be flexible with changing work needs

    • Interacts with other functional leaders, project management and QC/AD team personnel

    • Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners


 

Education





  • BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
 
 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.