Senior Analyst, Quality Control

About Technical Operations

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.

QC Senior Analyst SUMMARY The Quality Control Analytical Senior Analyst, under minimal supervision, is responsible for performing on-time release, stability, and non-routine testing of pharmaceutical drug substances and drug product under cGMP guidelines and procedures. The Senior Analyst works independently on assays they have mastered. The Senior Analyst, performs and/or reviews 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 is expected to demonstrate strong cGMP and compliance acumen. Presentation of laboratory results and conclusions, becoming a key subject matter expert for regulatory inspections, training, and educational development of other staff are also expected. 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 individuals 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. RESPONSIBILITIES

• Performs and/or reviews, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Works independently on assays that they have 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 analyses 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 completed 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 co-workers.
• 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
• Other duties as assigned.
  
  
  

EXPERIENCE Required Skills:

• At least 2 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.
• 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.
  
  
  

Desired Skills:

• Waters HPLC/UPLC experience
• Spectramax/Softmax Pro experience
• SDS-PAGE
  
  
  

EDUCATION

• B.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.
  
  
  

SHIFT DETAILS M-F Day Shift ONSITE, REMOTE, OR FLEXIBLE Onsite

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.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.