QC Viral Vector Analytical Lead

Location
Novato, California
Posted
May 14, 2022
Ref
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Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
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.

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
Qualifications
  • 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.
Education
  • 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.
Equipment
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.