Description

Who We Are

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.

Job Remit

• Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, continuously improving and in continued state of control and validation . Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.

Responsibilities

 

Stewardship– for the product steps(s) assigned:

• Is considered a process SME with in-depth understanding of both the scientific processes and large-scale operations
• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date,
• Review and assess any updates or changes of the Process description documents
• Create and maintain a process specific Risk register.
• Maintains oversight of process performance
• Reviewer of annual product reviews
• Support regulatory inspections  for process related aspects of assigned products when necessary.
• When required may lead / support root cause investigations of significant process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Maintains oversight and reviews process technical changes, reviews their technical feasibility and challenges technical risk
• Contribute to registration strategy and support registration activities.
• Responsible for ensuring the continued state of validation
• Reviewer and approver on MVPs and other process related validation documents such as the PCRAs
• Reviews and approves  continuous process verifications
• Ensure an appropriate process control strategy based on Critical Quality Attributes and other attributes as appropriate. 
• Reviews and approves any significant PPQ activities
• Approve validation protocol and report related to technical changes

Experience

• A minimum of 7 years’ relevant experience in the pharmaceutical or related industry with a strong technical services/MSAT experience.
• Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process.
• Ability to collaborate in a global team environment at all levels of the organisation
• Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
• Demonstrated ability to project manage technology transfer and/or new product launches is desirable.
• Use of Lean Six Sigma tools in continuous improvement projects.
• Excellent organizational, written and verbal communication & negotiation skills.
• Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is an advantage.
• Familiarity with an ERP systems and Trackwise documentation systems is desirable
• Demonstrated strong leadership and coaching qualities

Education

Bachelor’s degree or higher in Science or Engineering

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.