Analyst / Sr. Analyst, QC Product

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.

Summary

 

The QC Product Analyst under direct to minimal supervision is responsible for providing support to the on-time release, stability and non-routine testing of the pharmaceutical drug substances and drug product in a cGMP environment.  The QC Product Analyst is responsible for providing support to activities related to sample and/or lab equipment management.  The QC Product Analyst is responsible for assisting with troubleshooting work, supporting training to QC and Contract Test labs.

This position requires willingness to undergo training on more advanced analytical methods and employs laboratory safety policies at all times.  Work assignments will encompass performing and documenting activities from routine to non-routine samples and requires the ability to recognize deviations from the accepted practice. The analyst will be responsible for the timely completion of all assignments.  Good record keeping, organizational, written and verbal communication skills are essential.

Role Responsibilities

• Performs, under direct to minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Evaluates data against defined criteria/specifications.
• Assists in the revision of written procedures as assigned.
• Works independently on assays that he/she has mastered.
• Develops and maintains proficiency in a broad range of trained test methods.
• Trains other analysts in areas of expertise.
• Maintains the laboratory in an inspection-ready state.
• Maintains laboratory supply inventories.
• Ensures that support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory are met to meet business needs, such as lot release, method transfers, and validation studies.
• Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory requirements.
• Interacts with other departments at BioMarin as appropriate.
• Holds self and others responsible to abide by department and company policies and practices.
• Assist in revision of written procedures as assigned.

 

Education Required

• S./B.A. in Science (major in biology-biochemistry-chemistry).
• 2-3 years of relevant laboratory experience or A.S. with at least 4 years of relevant laboratory experience is desired.

Experience Required

• At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Demonstrates the ability to work independently.

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.