(CW) Senior QC Analyst

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.

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.

CONTRACT***Onsite from Monday to Friday***

Senior Analyst, Quality Control Analytical


The QC Analytical Senior Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.

The Senior Analyst works independently on assays they have mastered and performs advanced assays for multiple products. Work assignments will encompass performing and documenting activities and requires the ability to recognize deviations from approved procedures. Good record keeping, organizational, and written and verbal communication skills are essential.

The Senior Analyst is expected to demonstrate strong cGMP and compliance acumen, become a subject matter expert for regulatory inspections, and provide training and educational development of other staff.

RESPONSIBILITIES

• Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines
• Works independently on assays 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 in non-routine situations using a thorough understanding of the work processes and practices
• Identifies key issues in complex situations, analyzes problems, and makes sound decisions
• Assists in the revision of written procedures, method/equipment validation, and/or method transfers as assigned
• Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise
• Holds self and others accountable for adherence to department and company policies and practices
• Maintains a safety and quality focused culture

EXPERIENCE

Required Skills:

• 3+ years of experience in a cGMP/GLP laboratory
• 2+ years hands-on experience in separation sciences (HPLC, UPLC, CE)
• Ability to follow written instructions and to perform tasks with direct or minimal supervision
• Strong leadership skills demonstrated through past work history
• Use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel
• Good written and verbal communication skills
• Attention to detail and strong documentation skills
• Ability to contribute effectively in team environments and independently

Desired Skills:

• 3-5 years of Quality Control laboratory experience
• 3-5 years of hands-on experience in separation sciences (HPLC, UPLC, CE)

EDUCATION

• B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).

EQUIPME