Associate Director, Solutions Architect, PTD

BioMarin Pharmaceutical Inc

CA

JOB DETAILS
SALARY
$152,000–$209,000 Per Year
SKILLS
Adverse Events, Agile Programming Methodologies, Alliance/Partner Marketing, Analysis Skills, Analytics Cloud, Atlassian JIRA, Best Practices, Biology, Biotech and Pharmaceutical, Business Analysis, Business Processes, Calendar Management, Capacity Management, Clinical Trial, Code of Federal Regulations, Communication Skills, Compensation Management, Contract Manufacturing, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Database Report Tools, DevOps, Documentation, Environmental Sciences, FDA (Food and Drug Administration), Facebook, Fellowship, Functional Testing, GMP (Good Manufacturing Practices), Genetics, GxP, Human Health, Information Technology & Information Systems, Internet of Things, Inventory Management, Laboratory Information Management System (LIMS), Leadership, LinkedIn, Logistics, Maintain Compliance, Manufacturing, Manufacturing Automation, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing/Industrial Processes, Materials Management, Materials Requirements Planning (MRP), Medical Products, Medical Records, Medical Treatment, Microsoft Project, Molecular Biology, Newsroom, Operational Improvement, Operational Strategy, Operations Processes, Power BI, Press Releases, Problem Solving Skills, Process Flow, Process Improvement, Process Management, Production Management, Production Planning, Production Schedule, Project Execution, Project/Program Management, Publications, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Quality Metrics, Recruiting/Staffing Agency, Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Research & Development (R&D), SAP, SAP Administration, SAP PP, Schedule Development, Supply Chain, System Integration (SI), Systems Administration/Management, Technical Operations, Test Design, Test Scripts, Traceability, Warehousing
LOCATION
CA
POSTED
30+ days ago

b'nnnnnnnn Associate Director, Solutions Architect, PTD - BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnn nn

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n BioMarin Pharmaceuticaln

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Associate Director, Solutions Architect, PTD

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Location: United States

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Who We Are

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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.

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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.

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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 xe2x80x93 people with the right technical expertise and a relentless drive to solve real problems xe2x80x93 and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, wexe2x80x99ve 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.

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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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Overview:xc2xa0We are seeking an experienced SAP Solution Architect to spearhead the Plan to Deliver workstream, focusing on Manufacturing (In-house and Contract), Quality Processes, Inventory Management and Global Logistics, Production Planning and Detailed Scheduling, and Material Requirements Planning xc2xa0within a GxP-regulated environment. The architect will drive the integration of processes across critical boundary applications, including SAP, Laboratory Information Management Systems (LIMS), Warehouse Management Systems (WMS), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS), to ensure seamless operations, compliance, and efficiency.

Key Responsibilities:

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  • Solution Design, Implementation & Integration: n

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  • Responsible for designing, describing, and managing SAP solution design of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Deliver processes, including production planning, shop floor execution, quality management, and material management. n
  • Facilitate integration between SAP and boundary applications (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing, quality operations, and warehouse processes. n
  • Collaborate with cross-functional teams and business stakeholders to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA) and upholding xe2x80x9cfit to standardxe2x80x9d design principles in alignment with organizational goals. n
  • Develop and maintain functional specifications, process flows, integration plans and system configurations to ensure PTD processes scalability, reliability, and performance. n
  • Review configurations and deployments to maintain quality standards. n
  • Create clear, concise decision rationale documents balancing innovation with practicality, considering factors like cost, support, and compatibility with global end to end designs. n
  • Effectively communicate complex technical concepts to non-technical stakeholders and multifaceted business processes to technical stakeholders. n

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  • Manufacturing Support: n

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  • Support both in-house and contract manufacturing operations by configuring SAP solutions to manage production schedules, capacity planning, and material traceability. n
  • Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes. n

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  • Quality Control & Assurance: n

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  • Oversee the implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment. n
  • Enable integration with QMS for non-conformance management, CAPA (Corrective and Preventive Actions), and audit trails. n
  • Ensure traceability and compliance for quality-related data across SAP, LIMS, and QMS systems. n

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  • Stakeholder Collaboration: n

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  • Act as the primary liaison between business units (Manufacturing, Quality, Supply Chain) and IT teams to translate business requirements into technical specifications. n
  • Facilitate workshops, Cross functional Collaboration, requirement-gathering sessions, and solution design reviews to align stakeholders on process improvements and system capabilities. n
  • Guide cross-functional teams (e.g., SAP technical consultants, integration specialists, and business users) to deliver PTD solutions. n

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  • Project Management & Delivery: n

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  • Drive end-to-end project execution, including requirements analysis, solution design, testing, training, and go-live support for SAP and integrated subsystems. n
  • Develop and maintain project documentation, including business process flows, functional specifications, and test scripts. n

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  • Continuous Improvement: n

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  • Identify opportunities for process optimization and system enhancements to improve operational efficiency and compliance. n
  • Stay updated on SAP advancements, industry best practices, and GxP regulations to recommend innovative solutions. n
  • Act as strategic connector between business goals and technical execution to identify and recommend PTD solution improvements through post-implementation monitoring. n

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Qualifications:

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  • Bachelorxe2x80x99s degree in Business, Information Technology, Engineering, or a related field; advanced degree preferred. n
  • 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes. n
  • Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management); experience with SAP S/4HANA is a plus. n
  • Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment. n
  • Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes. n
  • Experience with in-house and contract manufacturing workflows, including batch management and material traceability. n
  • Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar. n
  • Strong analytical, problem-solving, and communication skills to bridge business and technical teams. n
  • SAP certifications (e.g., SAP PP, QM, EWM or S/4HANA) are highly desirable. n

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Preferred Skills:

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  • Knowledge of Industry 4.0 technologies, such as IoT or automation, in manufacturing environments. n
  • Familiarity with data analytics and reporting tools (e.g., SAP Analytics Cloud, Data Sphere Power BI) for process insights. n
  • Experience with Agile or DevOps methodologies for system implementation. 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: $152,000 to $209,000. 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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About the Company

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BioMarin Pharmaceutical Inc