QC Viral Vector Analytical Lead
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- May 14, 2022
View more
- Discipline
- Information Technology, Business/Data Analytics, Quality
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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.
Role
The 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 activity are:
- Scheduling of day-to-day laboratory operations and facilitation of huddles
- 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 members
- Management of laboratory resources (i.e. consumables, reagents, equipment availability)
- Identifying opportunities for process improvements and working with management to implement
- Testing of routine and non-routine samples
Key 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 environmental standards
- 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 members.
- Support coordination of CMMS processes.
- Collaboration with QC Associates, Supervisors, Managers, Scientists, and Head of QC VVA to ensure successful QC Laboratory operations
- Develop and maintain both internal and external relationships
- Author and review documents such as standard operating procedures and TrackWise records.
- Support investigations (LIRs and Deviations), change requests, CAPAs.
- 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 availability).
- Develop and Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Other job responsibilities as assigned
- At least five years in a cGMP laboratory; quality control experience required.
- Well-developed laboratory skills for analysis of pharmaceuticals, biopharmaceuticals. Experience in mammalian and insect cell culture, cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE
- 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 regulatory guidelines.
- 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 agencies.
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 COVID-19.
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.
Company
BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.
Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.
Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.
- Website
- https://www.biomarin.com/
- Location
-
California
United States
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