Sr. Technical Manager, QA

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.

RESPONSIBILITIES
 

• Perform independent review and approval of standard operating procedures and policies related to method life cycle management including validation, verification, transfer, evaluation and setting specification limits for release and stability testing, critical reagent and reference standard management.
• Review technical content of method submissions to regulatory authorities.
• Formalize business processes to incorporate health authority compliant continuous improvements of BioMarin’s products.
• Manage and approve change control related to method lifecycle.
• Evaluate the quality of the documentation and use systematic approaches to resolve findings by collaborating with Quality Control.
• Maintain knowledge of current industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
• Perform other Technical Quality related duties and projects as assigned by management.

EXPERIENCE

Required Skills:

• High level of proficiency in analytical method validation in a cGMP regulated environment.
• Understanding of FDA, EMA, PMDA and other international regulatory requirements, guidelines, and recommendations for methods lifecycle management.
• Knowledge of analytical instrumentation, software, and tests performed in the lab, including U/HPLC (IEX, SEC, RP, HIC), ELISA, CE-SDS, IEF, Raw Materials, etc.
• Familiarity with Quality Management Systems: GMP document management, deviation,
• , CAPA, and change control.
• Knowledge of microbiological assays including endotoxin and bioburden.
• Ability to work independently in an efficient and detail-oriented manner.
• Ability to work both independently and as part of a team.
• Ability to apply analytical reasoning to understand complex issues.

 

Desired Skills:

• Knowledge of analyses, such as Root Cause Analysis (RCA) and Failure Mode and Effects Analysis.
• Basic statistics knowledge and working experience.

EDUCATION

• BS in chemistry, biochemistry or biology or equivalent and +12 years experience in a cGMP regulated manufacturing environment.
• MS in chemistry, biochemistry or biology or equivalent and +10 years experience in a cGMP regulated manufacturing environment.
• PhD in chemistry, biochemistry or biology or equivalent and +6 years experience in a cGMP regulated manufacturing environment.

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.