Sr. Analyst, QCVVA
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 preferred.
- Perform laboratory testing of BioMarin drug products and API’s
- Analyze and review quality control release and stability testing data of BioMarin’s pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)
- 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, ICH).
- Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
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 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
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
- MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 years professional experience).
- 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.