Manager, Clinical Supply Chain

San Rafael, CA

Employer:

Description

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 Title: Manager, Clinical Drug Supply and Clinical Supply Chain Operations

Location: Hybrid which is 2-3 days onsite per week in San Rafael CA

About the Opportunity: The Manager, Clinical Drug Supply and Clinical Supply Chain Operations is responsible for supporting clinical studies with appropriate drug product supply. This includes translating clinical study information into a demand plan, managing clinical trial material supply from depots to the sites, and maintaining required essential documents. This role serves as the primary supply chain lead for the assigned clinical programs and acts as a key liaison between Technical Operations (TOPS) and Clinical Operations/study teams.

Responsibilities:

Drug Forecasting and Supply Planning: Translate clinical trial assumptions into drug forecasts and associated supply/distribution plans. Initiate required activities and supply execution processes, maintaining oversight of production, release, and distribution steps necessary to ensure continuous drug supply from First Patient In (FPI) through completion of the clinical trial
Team Collaboration: Participate in the planning, creation, and maintenance of Investigational Medicinal Product (IMP) supply project plans, including creating complex study forecasts with input from Clinical, Manufacturing, and Medical project managers as well as contract providers
Clinical Supply Chain Execution: Lead clinical supply chain execution teams and actively support clinical study teams in all matters related to drug supply to meet portfolio demands for programs progressing toward critical milestones
Vendor Management: Act as liaison with contractors (CMOs), manage supply budgets, explore opportunities to optimize budget, complete quarterly business and performance metrics, and negotiate quotes and work orders for new trials
Regulatory and Quality Compliance: Work with Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required. Assist in establishing and/or optimizing SOPs, protocols, and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements
Documentation and Quality Systems: Manage development of pharmacy manuals with appropriate internal subject matter experts. Manage Quality Systems required documentation, including Deviations, Investigations, CAPAs, Change Controls, Label and Product Specifications, and others as required
Project Management: Develop and apply Project Plans and Schedules that represent the appropriate level of detail and task independency. Ensure timely follow-up to all commitments in a project plan. Proactively address risk management issues and implement business continuity plans.
Financial Management: Prepare supply and cost forecasts as required. Identify cost reduction opportunities and develop and manage clinical supply budget. Experience with financial management of supply chain activities including assisting with departmental budgeting and oversight of external contracts.
Regulatory Inspections: Serve as subject matter expert on behalf of TOPS for clinical trial supply during regulatory inspections. Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for Trial Master File.

Minimum Requirements:

Minimum of 3 years of experience in a Clinical Supply Chain / Contract Manufacturing operation in the pharmaceutical or biotech industry
Strong interpersonal skills and awareness of the Emotional Quotient in a corporate environment to interact and resolve conflicts with many levels inside and outside of the Supply Chain Logistics organization internationally.
Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines, and global Health Authority requirements.

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.
The salary range for this position is: $116,000 to $174,000. 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.

For additional benefits information, visit: https://careers.biomarin.com/benefits .

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

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