QCVVA Sr. Analyst
The QC Sr. Analyst is responsible for providing technical leadership 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 the incumbent will work independently under minimal direction while accomplishing the timely completion of assignments and any necessary resolution of unexpected analytical issues. Work assignments will encompass activities from semi-routine to complex in nature with the ability to recognize deviations from the accepted practice. This position requires thorough theoretical knowledge and experience with applicable analytical methods. Good written and verbal communication skills are essential.
Functional activities may include:
•≥70% time spent in laboratory
•Performs advanced assays for gene therapy products
•Secondary review of data
•Evaluates data and trends results
•Conducts laboratory investigations/UERs
• Acts as Product/Project Coordinator
•Responsible for completion and compilation of data for product/project
•Interacts with other departments at BioMarin on a regular basis
•Provides technical leadership relative to the performance, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for clinical products
•Writes technical reports
•Mentors new hires
•Directly supervises no more than 1 hire
•Provides support to other analysts
•Maintains laboratory in inspection ready state and is expected to participate during internal and external inspections/audits
- Perform molecular biological, biochemical/chemical analyses of drug substance, drug product, clinical and stability samples under cGMP to meet specified timelines.
- Provide technical expertise and leadership to QC Analysts.
- Evaluate data and trend results.
- Troubleshoot assays.
- Prepare protocols, summaries and reports for routine and non-routine studies and analytical method validations.
- Maintain the laboratory in an inspection ready state.
- Interface with contract facilities and other BioMarin departments as necessary.
- At least 3 years years in a cGMP laboratory; quality control experience required.
- Well-developed laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
- Demonstrated ability to perform most tasks with limited supervision: general instructions on routine work, detailed instructions on new assignments.
- Computer literacy.
- Knowledgeable and conversant with 21CFR, USP, EP, and ICH regulatory guidelines
•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).
B.S. with at least 5 years experience 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.
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 Associate I 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.
Interacts with several departments, including but not limited to Manufacturing, Quality, Maintenance, Engineering, Regulatory Affairs, Clinical, Project Management, R&D, and Process Development. Contact and interaction with external contractors is also expected.
Supervises no more than 1 employee (QC Analyst)