Job Description

TITLE

Sr. Analyst, QC Critical Reagents

SUMMARY

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. 

The QC Critical Reagents Sr. Analyst is accountable for maintaining all aspects of the BioMarin Critical Reagents program for commercial products in the global network, including but not limited to maintaining material inventory, generating technical documentation, and supplying materials to the global testing network. Materials in the Critical Reagents program include qualified reagents, reference standards, custom reagents, analytical cell banks and other important materials that require dedicated oversight. The individual prepares trend graphs and analyses for Critical Reagents to support routine requalification activities, regulatory responses, and investigational activities.

RESPONSIBILITIES

• Author critical reagent technical documentation, including protocols and reports for qualification, requalification, expiry extension, qualified ranges, etc.
• Perform review and data verification of technical documentation.
• Maintains critical reagent trending graphs to monitor material stability, assay performance and suitability of qualified ranges, and to support technical documentation.
• Maintains critical reagent inventory and participates in forecasting of critical reagents supply demands and identifying resupply trigger points.
• Responsible for critical reagent acquisition, preparation, qualification testing coordination and release for use.
• Coordinates and executes critical reagent distributions for the global testing network.
• Supports document authoring, data compilation and analysis for regulatory submissions (BLA, MAA, etc.) and response letters (RTQs, etc.) for commercial products.
• Utilizes LIMS to document acquisition and preparation of critical reagents, to monitor testing status of critical reagents, and to extract data for trend analyses.
• Supports development, implementation and maintenance of critical reagent inventory management and data trending tools for hands-on use by the Quality organization (e.g. QC Site Testing groups in Novato and Shanbally)
• Initiates, completes and provide SME input for Quality Management System (QMS) processes, such as Change Controls, Deviations, Corrective Actions and Preventative Actions (CAPAs), etc.
• Participate in projects to meet timelines to ensure on-time delivery of results and establish priorities for final reports.
• Participate in the generation of new ideas to create efficiencies and improve processes; willingly supports new ideas and process enhancements. Engages in continuous improvement.
• Assist with regulatory and internal inspections, as needed.
• Attend team huddles, department meetings and standard work meetings as required.
• Other duties as assigned.

EXPERIENCE

Required Skills:

• Minimum 1 year relevant experience
• Experience with quality management systems, current Good Manufacturing Practices, and detailed knowledge of QC principles and compliance requirements.
• Excellent documentation, written and verbal communication skills.
• Computer literacy is required, including proficiency with Microsoft Word and Excel.
• Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or process requirements.

Desired Skills:

• At least 2 years of relevant experience preferred
• Demonstrated working knowledge and critical thinking with respect to certified functional activities.
• Works with ambiguity and complexity to continuously modify options and solutions.
• Applies sound problem-solving skills to recommend options and implement effective solutions.
• Experience with Microsoft PowerPoint, Teams, or Visio is desired.
• Familiar with relevant regulations, including 21CFR, USP, EP, and ICH requirements.

EDUCATION

• Bachelor’s degree in a related field, or Associate’s degree with additional relevant experience

EQUIPMENT

• Pipettes
• Balances
• pH Meter
• Biological Safety Cabinet
• Controlled Temperature Environments (CTEs), such as refrigerators and freezers
• Computer with statistical analysis and LIMS electronic softwares
• Other standard laboratory equipment

CONTACTS

• Quality Control laboratory management and analysts
• Analytical Product Leads
• Product Quality Leads
• Regulatory product leads
• Supply Chain – shipping and receiving teams
• Quality Assurance contacts

SHIFT DETAILS

• Primary working hours: Monday – Friday, day shift business hours (Pacific Time)
• Requires some flexibility to attend meetings outside of standard business hours to work with colleagues in other time zones

ONSITE, REMOTE, OR FLEXIBLE

• Flexible schedule, preferred 4 days on-site

TRAVEL REQUIRED

• Routine travel not required
• May include travel for trainings, conferences or visiting other sites, as assigned

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.