Sr. Analyst, Quality ControlLocation Novato, California Apply
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 Senior Analyst, under minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations for process development, lot release, and stability samples. The Senior Analyst works independently on assays that he/she has mastered.
The Senior Analyst will perform, under minimal supervision, sample testing compliant with cGMP guidelines. Performs several advanced assays for multiple products. 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 Senior Analyst will be responsible for the timely completion of all assignments. Good record keeping, organizational, written and verbal communication skills are essential. The senior analyst must be willing to work overtime and weekends as required to support the business need.
Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
Works independently on assays that he/she has mastered.
Develops and maintains proficiency in a broad range of test methods.
Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations.
Evaluates data against defined criteria/specifications.
Actively applies knowledge correctly in non-routine situations using a thorough understanding of the work processes and practices.
Leads and executes method/equipment validation, method development, and/or formulation studies and method transfers.
Identifies key issues in complex situations and analyzes problems and makes sound decisions.
Assists in the revision of written procedures as assigned.
Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise.
Maintains the laboratory in an inspection-ready state. 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.
Familiar with regulations cGMP, 21CFR, USP, EP, and ICH regulatory requirements.
Seeks, learns, and applies new job related training and knowledge and shares knowledge with coworkers.
Interacts with other departments at BioMarin on a regular basis.
Holds self and others responsible to abide by department and company policies and practices. Is responsible for setting a good example for more junior analysts in the department.
Three years in a cGMP/GLP laboratory; quality control experience is preferred.
Ability to follow written instructions and to perform tasks with direct or minimal supervision.
Demonstrate strong leadership skills through past work history.
Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
Good written, verbal, and communication skills.
Strong documentation skills a must.
Works independently as well in a team environment
B.S./B.A. in Science (major in biology-biochemistry-chemistry).
3-5 years of relevant laboratory experience or A.S. with at least 6 years of relevant laboratory experience is desired.
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.