Associate, QC Raw Materials

Location:  Novato, California Category: Quality

Hiring Manager: Elia Sanchez (el909959@bmrn.com), Lyndi Rice (ly898888@bmrn.com)

Description

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.

TITLE: QC Associate 1, Raw Materials
 
SUMMARY 
The QC Associate 1, Raw Materials, supports the Quality Control Analytical Laboratory on testing, approval, and release of raw materials used in the manufacturing process of BioMarin Products at the Novato Site. 
 
RESPONSIBILITIES 
  • The associate will be responsible for executing tests, reviewing data and approving assays in support of raw materials release.
  • Provide technical expertise for raw materials analytical methods in QC, support the maintenance of methods and analytical equipment performance. 
  • May investigate out of specification results, invalid results and troubleshoot compendial methods in support of raw materials lot release. 
  • The QC Associate will also be the point of contact with contract laboratory operations for methods that are being sent out to contract laboratories for testing.
  • The QC Associate also works with continuous improvement ideas to streamline the laboratory processes and minimize risks to operations.
  • May work in method verification, qualification activities for new raw materials and New Product Introductions or Technology Transfers.
  • The QC Associate ships raw materials samples to contract laboratories, is the liaison between laboratories, enters results in LIMS, and may approve results needed for manufacturing operations.
 
EXPERIENCE
 
Required Skills:
·         Moderate experience in Compendial Analytical test methods
·         Analyze, trend, and review quality control non-routine, and release testing data
·         Authoring protocols and reports in support of raw materials testing. 
·         Develop, optimize, validate and troubleshoot analytical test methods
·         Draft and revise QC Standard Operating Procedures
·         Act as technical resource (Subject Matter Expert -SME) and provide training to other analysts in areas of expertise
·         May own quality system records. Initiate and/or act as investigator/owner for laboratory investigations, deviations, related corrective, preventative actions and change control records.
·         Maintain the laboratory in an inspection-ready state including support of equipment management 
·         Present laboratory results and conclusions, key subject matter expert for regulatory inspections, training and training and development of other analysts.
 
 
Desired Skills:
Minimum of 5 years of good manufacturing practices (GMP) and good laboratory practices (GLPs) or laboratory related experience. Experience in Biochemistry, Wet Chemistry Methods, and Separations methods (i.e. HPLCs) is preferred.
 
EDUCATION
Bachelor’s degree in Chemistry, Biological Sciences, or any other relevant scientific field.  
 
 
 
EQUIPMENT 
The QCA Associate must develop skills in the operation and routine maintenance of various analytical instruments and computers. The Associate must develop necessary skills to understand the operation of the equipment, gain knowledge of the equipment used for testing, and use these skills to work with their supervisor/manager in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation. 
 
CONTACTS 
This position will not have direct reports; however, leadership skills are highly recommended and training and coaching skills are preferred.
 
The Associate will be able to interact with the QC Leadership team, Quality Assurance, Manufacturing, Materials Management, and the Supply Chain teams in projects and initiatives related to routine and non-routine raw materials supply/demand operations.
 
SHIFT DETAILS 
This position is Mondays to Fridays (8:30am – 5:00pm)
 
ONSITE, REMOTE, OR FLEXIBLE 
Onsite work is preferred, but the employee can work remotely, if needed. A minimum of four days on site and 1 day remote is preferred.  
 
TRAVEL REQUIRED 
Traveling may be required to support Ireland QC Operations. The frequency could be once a year.  



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.