QC Viral Vector Analytical Lead
Company: BioMarin Pharmaceutical Inc.
Posted on: May 14, 2022
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
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
RoleThe QC Viral Vector (QC VVA) Lead is responsible for supporting
supervisors in day-to-day laboratory activities and ensuring the
laboratory is always in an inspection-ready state. The QC Lead will
support the team to maintain compliance in accordance with internal
procedures and health agency requirements.The main areas of QC VVA
- Scheduling of day-to-day laboratory operations and facilitation
- Ensuring GXP compliance within the laboratory and maintaining
an investigation-ready state
- Data review and LIR and deviation investigation support
- Providing technical support and training to junior team
- Management of laboratory resources (i.e. consumables, reagents,
- Identifying opportunities for process improvements and working
with management to implement
- Testing of routine and non-routine samplesKey Responsibilities
- Scheduling day-to-day activities, including testing and
housekeeping and facilitating huddles. Ensures that all tasks are
completed in a timely and compliant manner.
- Provide cGMP expertise for all aspects of testing and
laboratory operations within the laboratory.
- Support testing of all samples and data review. Support
housekeeping as necessary.
- Ensure the team is compliant to GXP and safety and
- Represent team needs on behalf of QC VVA for cross-functional
groups, testing needs, and project teams.
- Provide trouble-shooting and technical training to junior team
- Support coordination of CMMS processes.
- Collaboration with QC Associates, Supervisors, Managers,
Scientists, and Head of QC VVA to ensure successful QC Laboratory
- Develop and maintain both internal and external
- Author and review documents such as standard operating
procedures and TrackWise records.
- Support investigations (LIRs and Deviations), change requests,
- Develop subject matter expertise in multiple lab systems or
assay methodologies and support optimization when appropriate.
- Proactive communication to management about compliance risks
and deviations with a focus on solutions.
- Responsible for laboratory resources management to ensure
uninterrupted testing (lab consumables, reagents, and equipment
- Develop and Demonstrate an active approach to safety,
industrial hygiene, environmental and regulatory compliance
- Other job responsibilities as assignedQualifications
- At least five years in a cGMP laboratory; quality control
- Well-developed laboratory skills for analysis of
pharmaceuticals, biopharmaceuticals. Experience in mammalian and
insect cell culture, cell-based assays, qPCR, HPLC, ELISA,
- Demonstrated ability to perform most tasks with limited
supervision: general instructions on routing work, detailed
instructions on new assignments.
- Computer literacy.
- Knowledge and conversant with 21CFR, USP, EP, and ICH
- B.S. with at last 5 years 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. or
- M.S. with at least 3 years of experience in a relevant
functional area and thorough knowledge of cGMPs and regulations
applicable to the FDA and comparable international regulatory
A QC Lead should be experienced with the operation and maintenance
of a wide range of analytical instrumentation and should possess or
develop an understanding of the theoretical basis for instrument
function, especially as it relates to troubleshooting and
monitoring system suitability trends.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits
vaccinations, all our incoming employees must be vaccinated for
We are an equal opportunity employer and all qualified applicants
will receive consideration for employment without regard to race,
color, religion, gender, gender identity, sexual orientation,
national origin, disability status, protected veteran status, or
any other characteristic protected by law.
Keywords: BioMarin Pharmaceutical Inc., Novato , QC Viral Vector Analytical Lead, Other , Novato, California
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