Manager / Sr. Manager, Analytical Services GXP Laboratory

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San Rafael

BioMarin Pharmaceutical

Manager / Sr. Manager, Analytical Services GXP Laboratory

Location: San Rafael, United States

Workstyle: Onsite Only

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Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on peopleâ€s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarinâ€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 BioMarinâ€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.

The Manager / Senior Manager, Analytical Services GxP Laboratory provides scientific, technical, and operational leadership for analytical activities supporting commercial products and late-stage development programs. This role is part of the global Analytical Services and Commercial Product Support organization and is responsible for leading a team of scientists and research associates engaged in analytical method transfers, method validation, method troubleshooting, remediation activities, stability studies, investigations, and regulatory support within a cGMP environment.

The Manager / Senior Manager ensures the delivery of high-quality analytical data, regulatory compliance, inspection readiness, and efficient execution of business objectives. This position partners closely with Analytical Product Leads, Quality Control, Manufacturing, Technical Development Services, Quality Assurance, Regulatory Affairs and external laboratories to support product lifecycle management and commercialization activities.

The successful candidate will balance people leadership, scientific oversight, operational excellence, and strategic planning to ensure the Analytical Services organization delivers reliable, compliant, and efficient analytical support across the product portfolio.

This role reports to the Head of Analytical Services and Commercial Product Support in Analytical Sciences.

Key Responsibilities

People Leadership and Talent Development

• Lead, coach, and develop a team of scientists, Senior Research Associates, and Research Associates within the GxP Analytical Services organization 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 to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives.
• Establish clear performance expectations, development plans, provide actionable feedback, and chart career growth opportunities.
• Foster a culture of accountability, agility, collaboration, innovation, compliance, and continuous improvement.
• Support staffing, recruiting, onboarding, succession planning, and organizational development activities.
• Build and maintain a highly engaged, technically capable, and inspection-ready team.
• Ensure all individual training and guidelines are kept current.
• Set short- and long-term department goals oriented to a high performing function.
• Contribute to annual budget planning and forecasting activities, ensuring operational expenditures are in-line with budget.

Technical and Scientific Leadership

• Provide technical oversight for analytical method transfers, validation, qualification, verification, troubleshooting, and remediation activities.
• Serve as a scientific reviewer and approver for complex technical documents, protocols, reports, investigations, and laboratory studies.
• Guide technical strategy for analytical method lifecycle management across commercial and development programs, supporting key global initiatives for the organization.
• Support root cause investigations, complex technical problem-solving efforts, and risk assessments.
• Drive scientific decision-making using data-driven and risk-based approaches.

Operational Management

• Establish priorities, timelines, and resource allocations to support portfolio objectives and business commitments.
• Own deliverables for the team and drive accountability at all levels to ensure timelines are met.
• Ensure efficient laboratory operations, including scheduling, equipment utilization, capacity planning, and workload management.
• Monitor project progress and proactively identify risks, constraints, and mitigation strategies, escalating constraints to management in a timely manner.
• Manage and perform activities associated with method validation and transferused to support BioMarinâ€s programs, including, but not limited to, Contract Testing Organizations (CTOs), In-Country test labs, and strategic partners.
• Develop and track departmental goals, metrics, and key performance indicators.
• Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence.
• Provide technical expertise for analytical methods in QC, including training of analysts as required.

Quality and Compliance

• Ensure compliance with all applicable GMP, GDP, EHS, data integrity, and regulatory requirements.
• Maintain laboratory inspection readiness and support internal audits, regulatory inspections, and client audits.
• Review and approve deviations, investigations, CAPAs, change controls, and quality records.
• Ensure all staff maintain training qualifications and adherence to approved procedures.
• Partner with Quality organizations to strengthen quality systems and compliance practices.
• 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 â€" often for direct submission to pharmaceutical regulatory agencies.
• Ensure the team is compliant to GxP and safety and environmental standards.

Technical Writing and Documentation Oversight

• Write, review and approve technical documentation, including analytical procedures, validation protocols and reports, transfer protocols and reports, technical assessments, QMS records, and regulatory documentation.
• Ensure scientific quality, technical accuracy, and regulatory compliance of documents generated by the team.
• Support regulatory submissions, health authority responses, and inspection preparation activities.

Cross-Functional and External Engagement

• Represent Analytical Services on cross-functional project teams and governance forums.
• Partner with Manufacturing, Quality Control, Regulatory Affairs, Quality Assurance, and Technical Development organizations to achieve program objectives.
• Manage technical interactions with contract testing laboratories, contract manufacturing organizations, and external collaborators.
• Communicate project status, risks, and strategic recommendations to management and key stakeholders, ensuring alignment to the tier process for escalations.
• Provide technical support to stakeholders and partners during investigations and audits.
• Ensure aligned approaches to GXP activities across sites, partnering closely with GXP leaders throughout the AS organization.

Strategic Planning

• Contribute to departmental strategy, budget planning, capacity forecasting, and organizational initiatives.
• Evaluate emerging technologies, analytical approaches, and regulatory expectations to improve laboratory capabilities.
• Drive analytical science and operational strategies that support product lifecycle management and long-term business objectives.

Qualifications

Manager

Education and Experience

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline with typically 8+ years of relevant pharmaceutical or biotechnology industry experience; or
• Master's degree with typically 6+ years of relevant experience.
• Prior experience leading projects, technical teams, or laboratory workstreams.
• Previous experience leading a high-performing team is preferred.

Knowledge and Skills

• Strong understanding of analytical method validation, transfer, troubleshooting, and lifecycle management.
• Working knowledge of cGMP regulations, data integrity requirements, and quality systems.
• Demonstrated leadership and project management capabilities.
• Strong technical writing and scientific review skills.
• Excellent organizational, communication, and stakeholder management abilities.

Senior Manager

Education and Experience

• Bachelor's degree with typically 12+ years of relevant industry experience; or
• Master's degree with typically 10+ years of relevant experience.
• Significant experience leading teams within pharmaceutical, biotechnology, quality control, or analytical development organizations.

Knowledge and Skills

• Demonstrated success leading multiple programs, technical teams, and organizational initiatives. Experience leading a high performing team is preferred.
• Strong experience managing regulatory inspections, audits, and compliance programs.
• Proven ability to influence cross-functional strategy and organizational priorities.
• Experience managing budgets, staffing plans, resource forecasting, and departmental operations.
• Recognized technical expertise in analytical sciences and GMP laboratory operations.

Success Factors

The successful candidate will:

• Demonstrate strong scientific and business judgment.
• Develop high-performing teams through coaching and mentorship.
• Effectively prioritize competing business demands.
• Promote a culture of compliance, safety, quality, and continuous improvement.
• Build strong cross-functional partnerships across the organization.
• Deliver reliable analytical support that enables product development, commercialization, and ongoing supply of therapies to patients.

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.

Ireland Safety Responsibility Support the organisationâ€s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisationâ€s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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The salary range for this position is: $124,000 to $170,500. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

Click here to review "EEO Is The Law" poster. Click here to review the Pay Transparency Nondiscrimination Statement. Click here to review the Notification of Employee Rights under Federal Labor Laws.

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