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Who We Are
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.
About the Opportunity:
Minimum Requirements:
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Who We Are
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.
About the Opportunity:
- The Clinical Supply Chain Operations Manager is responsible for supporting clinical studies with appropriate drug product supply, including 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.
Minimum Requirements:
- Minimum of 3 years of experience in a Clinical Supply Chain / Contract Manufacturing operation in the pharmaceutical or biotech industry and 1 year of experience in a GMP environment preferred
- Strong interpersonal skills and awareness of the Emotional Quotient in a corporate environment are required to allow the incumbent to interact and resolve conflicts with many levels inside and outside of the Supply Chain Logistics organization internationally
- The Clinical Supply Chain Operations (CSC Ops) Manager translates clinical trial assumptions into drug forecasts and associated supply/distribution plans, initiates required activities & supply execution processes, and maintains oversight of the production, release, and distribution steps necessary to maintain a continuous supply of drug from FPI through completion of the clinical trial.
- The CSC Ops Manager is a standing member of the CMC and Study Execution Teams (SET) and acts as a key liaison between TOPS and Clinical Operations/study teams. The CDS Manager is a primary TOPS interface to our Clinical Operations customers and is the contact for all strategic Clinical Supply related issues as it relates to finished supplies.
- Participate in the planning, creation and maintenance of IP supply project plans, including creating complex study forecasts with input from Clinical, Manufacturing and Medical project managers as well as contract providers
- Lead Clinical Supply Chain execution teams and actively participate and support clinical study teams in all matters related to drug supply as needed to support the portfolio demands for programs progressing toward critical milestones where end to end Supply Chain execution is required for world class Clinical Supply delivery.
- Act as liaison with contractor(s) (CMO's). Actively manage supply budgets and explore opportunities to optimize budget. Complete quarterly business and performance metrics. Negotiate quotes and work orders for new trials.
- 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.
- Manage development of pharmacy manuals with appropriate internal subject matter experts.
- Manage vendor selection for clinical study support, including clinical packaging and labeling facilities as required. Work with Regulatory Compliance and QA in selection/qualification of CMO's.
- Manage Quality Systems required documentation, including Deviations, Investigations, CAPA's, Change Controls, Label and Product Specifications, and others as required.
- 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.
- 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.
- 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
- Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
