Director of Drug Substance Operations, Global External Operations

b'nnnnnnnn Director of Drug Substance Operations, Global External Operations | BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn

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n BioMarin Pharmaceuticaln

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Director of Drug Substance Operations, Global External 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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Summary:

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• The Director, Drug Substance Operations is a key leadership role within Global External Operations (GEO), accountable for endxe2x80x91toxe2x80x91end operational oversight of BioMarinxe2x80x99s external drug substance manufacturing network.xc2xa0 n
• This role ensures reliable, compliant, and uninterrupted supply of drug substance from Contract Manufacturing Organisations (CMOs) to support clinical and commercial demand. The position drives operational performance through robust governance, KPIxe2x80x91driven management, and execution of a structured CMO oversight model.xc2xa0 n
• The Director partners across Technical Operations, External Quality, Supply Chain, and Technical Development to deliver integrated, riskxe2x80x91based oversight of external manufacturing while enabling successful product launches, lifecycle management, and network scalability. n
• This role combines strategic leadership with handsxe2x80x91on operational execution, ensuring the GEO organisation maintains an inspectionxe2x80x91ready, highxe2x80x91performing external manufacturing network aligned with enterprise objectives. n

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CMO Operations & Supply Performance

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• Provide end to end operational leadership and oversight of CMOs to ensure delivery of reliable, compliant drug substance supply n
• Ensure uninterrupted product supply by proactively identifying, escalating, and resolving risks via the GEO tiered escalation framework n
• Serve as the primary operational interface for critical CMO issues, ensuring timely resolution and clear communication n

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Governance & Performance Management

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• Establish and maintain robust CMO governance frameworks aligned with GEO standards n
• Define, monitor, and drive performance against key operational KPIs and scorecards n
• Lead performance reviews, identify systemic risks, and implement targeted improvement plans n
• Ensure governance requirements, oversight expectations, and site engagement models are consistently applied n

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Partnership & Stakeholder Management

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• Build and maintain strategic relationships with CMO leadership teams to enable issue resolution and long term performance n
• Partner with Virtual Plant Teams (VPTs) and cross functional stakeholders to ensure integrated oversight of external operations n
• Align internal and external stakeholders on priorities, risks, and execution plans n

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Operational Readiness & Program Delivery

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• Ensure execution of Operational Readiness Planning (ORP) for new products, tech transfers, and major process changes n
• Support successful technology transfers and lifecycle management activities across the network n
• Ensure readiness for regulatory inspections and audits through effective operational control and governance n

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Strategy, Continuous Improvement & Value Delivery

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• Develop and execute operational strategies aligned with GEO and enterprise objectives n
• Drive value realisation initiatives, including cost optimisation, efficiency improvements, and operational excellence n
• Identify and implement process improvements to enhance standardisation, scalability, and cross functional ways of working n

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People Leadership

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• Lead and develop a high performing operations team, fostering accountability, capability development, and engagement n
• Provide clear direction, coaching, and performance management to ensure delivery of business objectives n
• Lead a team of 4-6 professionals across US & Ireland. n
• Build organisational capability to support current priorities and future network growth n

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Education & Experience

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• Bachelorxe2x80x99s or advanced degree in Science, Engineering, or related discipline n
• Significant experience in pharmaceutical or biotech operations, including external manufacturing and CMO managementxc2xa0 n
• Demonstrated leadership experience in a global, matrixed organisationxc2xa0 n
• Proven track record in delivering operational performance, supply reliability, and continuous improvementxc2xa0 n
• Strong knowledge of GMP and regulatory expectations n

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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: $174,400 to $239,800. 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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