Sr. Analyst, QCVVA
Posted on: June 8, 2021
Sr. Analyst, QCVVA
Location Novato, California Apply
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 patients' lives.
The QC Analyst is an entry level member of the Quality Control
team and is responsible for providing testing support relative to
the performance, validation, optimization, development,
troubleshooting, and transfer of molecular biological, biochemical
and chemical evaluations for drug substance, drug product. It is
expected that he/she will work independently under minimal
direction while completing work assignments from semi-routine to
mildly complex in nature and will escalate issues as needed. The
ability to recognize deviations from the accepted practice/SOPs
through foundational technical expertise and compliance is a
requirement. Good written and verbal communication skills are
essential. PCR and cell-based method experience is highly
- Perform laboratory testing of BioMarin drug products and
- Analyze and review quality control release and stability
testing data of BioMarin's pharmaceutical products at Contract
Testing Laboratories (CTLs) and/or Contract Manufacturing
- Support the preparation of phase-appropriate stability
protocols and stability reports for API and drug product in
accordance with regulatory requirements and as needed to support
clinical trials and regulatory submissions
- Support investigations conducted at CMO/CTL and review and
approve out-of-specification (OOS), out-of-trend (OOT) and
out-of-expectation (OOE) testing results, deviations.
- Support the transfer of analytical methods to CTL's for gene
therapy products. These methods may include HPLC, ELISA, and other
methods, such as cell-based potency methods.
- Support continuous improvement in quality systems (procedures
and systems) to improve organizational effectiveness, quality
assurance compliance, and regulatory and other requirements (cGMP,
- Work collaboratively with manufacturing/supply chain, quality
assurance, regulatory, and project management to ensure timely
availability of lot release, stability data, and other required
Qualifications / Requirements:
- 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
- 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
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry,
Analytical Chemistry, or a related field (with 0 - 2 years
- MS in Molecular Biology, Genetics, Chemistry, Biochemistry,
Analytical Chemistry, or a related field (with 0 years professional
- 3-5 years of relevant laboratory experience or A.S. with at
least 6 years of relevant laboratory experience is desired.
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, Novato , Sr. Analyst, QCVVA, Other , Novato, California
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