Technical Manager / Sr. Technical Manager, CTO Quality Management & Operations

b'nnnnnnnn Technical Manager / Sr. Technical Manager, CTO Quality Management & Operations | BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn

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n BioMarin Pharmaceuticaln

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Technical Manager / Sr. Technical Manager, CTO Quality Management & Operations

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Location: United States

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Workstyle: Remote Only

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Who We Are

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

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s 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.

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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.

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About Technical Operations

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BioMarinxe2x80x99s 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 BioMarinxe2x80x99s 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.

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Role Summary

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The Manager, CTO Quality Management & Operations is responsible for GMP Quality oversight of Contract Testing Organizations (CTOs) that perform testing of BioMarin intermediates, drug substance/API, and drug product across the legacy BioMarin and Amicus portfolios. The role ensures external testing activities are executed in compliance with approved methods, regulatory filings, Quality Technical Agreements (QTAs), and BioMarin policies and procedures, with particular focus on method transfers, release testing oversight, and quality issue resolution at assigned CTOs.

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The incumbent acts as a key Quality point of contact for assigned external testing partners and plays a pivotal role in ensuring effective communication and streamlined processes for outsourced QC testing. They partner cross-functionally with Analytical Sciences, Regulatory Affairs, Supply Chain, Procurement, and Site Quality to ensure external testing models remain compliant, sustainable, and aligned with BioMarin's QC Network Strategy.

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Key Responsibilities

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CTO Oversight:

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• Own day-to-day Quality oversight of assigned CTOs and ICT laboratories, ensuring external testing is performed in accordance with approved methods, QTAs, regulatory filings, and BioMarin requirements. n
• Lead the Quality oversight strategy for assigned CTOs by assessing CTO health and developing risk-reduction and performance-improvement plans in partnership with CTOs. n
• Lead and facilitate Quality Review Meetings (QRMs) and ongoing performance monitoring with assigned external laboratories. n

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Method Transfer & Lifecycle Management:

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• Project manage the transfer of analytical methods into CTOs and ICT labs, liaising internally with SMEs across Analytical Sciences, QC, and Regulatory. n
• Support method validation, verification, and lifecycle management activities at external and in-country testing laboratories. n
• Support in-country testing requirements, including the set-up of in-country central labs and registration testing as required for market launches. n

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Quality Systems & Compliance

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• Lead and/or support GMP quality system activities related to external testing, including deviations, investigations, CAPAs, change controls, quality risk assessments, and product complaints. n
• Own, maintain, and administer Quality Technical Agreements (QTAs) and support alignment of GMP roles and responsibilities with external testing partners. n
• Partner with BioMarin Global Compliance & Ethics (GCE) to schedule compliance audits and resolve compliance gaps identified, including those from health authority inspections. n
• Ensure inspection readiness through oversight of compliant documentation, timely response to audit findings, and verification of corrective actions associated with external testing partners. n

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Cross Functional & Network Support

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• Serve as a Quality representative on cross-functional teams, providing GMP guidance to ensure quality considerations are incorporated into decisions impacting external testing. n
• Provide GMP Quality oversight for the integration of new QC workstreams, including those associated with new products, acquisitions, or changes to the external testing network. n
• Provide Quality input to budget, Annual Operating Plan (AOP), and forecast activities related to external testing. n

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Qualifications

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• Bachelor's degree in a scientific or engineering discipline (Chemistry, Biology, Pharmaceutical Sciences, or related). Advanced degree preferred. n
• Minimum 6+ years of GMP Quality experience in pharmaceutical or biotech, with demonstrated experience overseeing contract laboratories or external QC operations. n
• Working knowledge of US (FDA) and European (EMA) GMP regulatory requirements, guidelines, and expectations; additional jurisdictions (e.g., PMDA, ANVISA, NMPA) a plus. n
• Strong understanding of analytical method transfer, validation, and QC release testing for drug substance and drug product. n
• Experience with QTAs, deviations/CAPA, change control, and quality risk management. n
• Strong project management and stakeholder communication skills; able to manage multiple CTO relationships and competing priorities. n
• Inspection-readiness mindset: values clear documentation, evidence-based decision-making, and rigorous due diligence. n
• Collaborative and cross-functionally oriented; able to influence without authority across Quality, Analytical Sciences, Regulatory, Supply, and Procurement. n
• Demonstrated ability to operate independently in a remote/hybrid environment with global stakeholders. n

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Approximately 10xe2x80x9320% domestic and international travel to CTOs, ICT partners, and BioMarin sites as required.

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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.

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Equal Opportunity Employer/Veterans/Disabled

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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.

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The salary range for this position is: $129,400 to $177,870. 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

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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.

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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.

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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.

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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

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Equal Opportunity Employer/Veterans/Disabled

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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.

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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, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis 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.

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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 xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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