Analyst, QC Analytical In-Process
Description
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.
ROLE
The Quality Control Analytical (QCA) Analyst is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination, Bradford, UV Absorbance, Enzyme activity, and HPLC/UPLC analysis.
CHARACTERISTICS
Functional activities may include: performing a wide variety of analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, supporting investigations and equipment validation, and brainstorm further development or improvement ideas for procedures. Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritize routine work effectively. QCA Employee must be able to interpret results against defined criteria, begin to apply critical thinking to routine work. He/she should demonstrate an ability to evaluate results against trend reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active role in following up on atypical results or issues. Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential. Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the work schedule flow permits, and maintain a positive attitude. He/she must be willing to work second shift, overtime, weekends, and holidays as required.
• Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
• Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
• Evaluate completed assay validity, calculate, and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
• Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
• Assist with monitoring and the control of laboratory supply and critical reagent inventories.
• Qualify as trainer for specified methods, provide training to less experienced staff.
• Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
• Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
• Perform other responsibilities as deemed necessary.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.