Sr. Manager, Analytical Services

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.

Job Summary

The Sr. Manager, Analytical Services is a leadership position in the Analytical Sciences team, focused on leading a team of Scientists, Research Associates and Analysts in development, optimization, validation, transfer and troubleshooting of analytical test methods for new and existing products throughout lifecycle of analytical test methods. The Senior Manager is also accountable for maintaining an inspection ready laboratory.

KEY RESPONSIBILITIES

Department Leadership and Management

• Collaborate with AS Functional Head and People Department to identify needs and participate in recruiting, hiring, and promoting staff
• Lead and develop a cohesive, balanced, and high functioning team focused on producing high quality deliverables and outcomes
• Optimize the organizational design and allocation of team resources across the Technical Lab Operations to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives
• Mentor, coach and inspire Analytical Services team on BioMarin skill and career development
• Ensure all individual training and guidelines are kept current.
• Set short- and long-term Analytical Services department goals oriented to a high performing Analytical Services function (e.g., Objectives and Key Results (OKRs))
• Manage annual budget, operational expenditures, and forecasting activities
• Lab Operations, Method Development, Optimization, Validation and Transfer

Oversee/Manage the development, validation, and transfer of analytical/bioanalytical methods used in BioMarin's clinical and commercial testing operations and process development labs

• Delegate responsibilities of laboratory equipment qualification and maintenance, where applicable
• Write/Review protocols, experimental designs to support clear instructions for implementation / execution of experiments
• Design and execution of special studies for product development activities
• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin's programs including, but not limited to, to Contract Testing Organizations (CTOs), In-Country Test Labs and strategic partners
• Provide technical expertise for analytical methods in QC, including training when required
• Support the maintenance and management of method and analytical equipment performance
• Troubleshoot and develop the plan for optimization of analytical methods
• Review and approve documents such as, but not limited to, Quality Control standard operating procedures, method validation, verification, transfer protocols, protocols, reports and TrackWise records
• Review analysis and trends, for quality control non-routine data
• Analyze and review QC Laboratory investigations for trends to support assessments that affect assay life cycle management
• Provide technical support to Manufacturing, Quality and QC during manufacturing and/or QC investigations, when required

Regulatory Compliance, Audit and Site Support

• Ensure the laboratory in an inspection-ready state and that all Analytical Services staff take part in maintaining the lab in an inspection ready state
• Provide technical support for site and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)
• Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
• Interact directly with regulatory agency inspectors during audits
• Prepare and review documentation to cGMP standards - often for direct submission to pharmaceutical regulatory agencies
• Ensure the team is compliant to GxP and safety and environmental standards

Process Improvement and Training

• Support the implementation and management of GxP method training within Analytical Services
• Support improvement activities to ensure delivery of scientifically sound and efficient QC methods
• Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH)

SKILLS AND EXPERIENCE

• Method Development, Optimization, Validation, Transfer, and Lifecycle Management
• Expertise in biochemical techniques such as enzymatic activity, enzyme kinetics, and cell-based method.
• Excellent people development skills and team leadership
• Excellent communication and stakeholder management skills
• Organizational skills and and aptitude for developing robust processes to improve efficiency in the labs
• Experience leading teams through organizational change
• Process Development and/or Manufacturing science experience preferred
• Experience supporting CMC teams preferred

EDUCATION:

B.S +10 years experience, MS + 8 years experience, or PhD + 3-5 years experience

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.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.