Vendor Laboratory Manager (VLM)

Lyten; United States; Remote; USD 75,000 - 115,000; Full time

Job summary

An established industry player seeks a Vendor Laboratory Manager to oversee vendor performance in clinical trials. This role involves managing vendor relationships, ensuring compliance with quality standards, and driving biomarker strategy implementation. The ideal candidate will possess a strong background in life sciences, project management, and vendor management. Join a forward-thinking team dedicated to advancing human health through innovative solutions. This position offers an exciting opportunity to contribute to clinical operations and ensure the ethical handling of biospecimens, making a significant impact in the biotechnology field.

Qualifications

• Master's or Bachelor's degree in life sciences with relevant experience.
• Experience with biospecimen processing and vendor management.
• Knowledge of clinical drug development and regulations.

Responsibilities

• Oversee vendor activities in compliance with policies and standards.
• Manage biospecimen collection and data quality.
• Collaborate with cross-functional teams for performance feedback.

Skills

Project Management

Vendor Management

Biospecimen Processing

Communication Skills

Problem-Solving

Education

Master's Degree in Life Sciences

Bachelor's Degree in Life Sciences

Tools

Microsoft Office

Labmatrix

Project Management Tools

LIMS Systems

Job description

Who We Are

BioMarin is a global biotechnology company dedicated to advancing human health through innovative genetic medicines.

Our Clinical Laboratory & Biospecimen Management (CLBM) team within Strategic Research and Development Operations (SRDO) oversees vendor management for laboratories involved in clinical trials, ensuring ethical and efficient biospecimen handling and data delivery.

The Vendor Laboratory Manager (VLM) plays a crucial role in managing vendor performance across all phases of clinical protocols, from study start-up to close-out. The VLM develops documentation, manages vendor relationships, and ensures compliance with quality standards and regulations.

KEY RESPONSIBILITIES:

- Oversee vendor activities in compliance with BioMarin policies and regulatory standards.
- Lead vendor meetings, track deliverables, and ensure milestones are met.
- Manage biospecimen collection, analysis, and data quality, ensuring adherence to ethical standards.
- Identify and mitigate risks, resolve operational issues, and escalate as necessary.
- Support quality assurance activities, including investigations and CAPA.
- Review and manage vendor invoices and budgets.
- Collaborate with cross-functional teams and participate in meetings to provide updates and performance feedback.
- Drive biomarker strategy implementation and oversee data timelines.
- Review protocols, consent forms, and related documents for biospecimen management.
- Serve as the primary contact for biospecimen requests and inquiries.
- Contribute to process improvements and team goal setting.

QUALIFICATIONS:

- Master's or Bachelor's degree in life sciences with relevant experience in project management, clinical operations, or laboratory settings.
- Experience with biospecimen processing, biomarker operations, and vendor management.
- Knowledge of clinical drug development, regulations (ICH/GCP/GLP), and laboratory practices.
- Strong organizational, problem-solving, and communication skills.
- Proficiency in relevant software such as Microsoft Office, Labmatrix, and project management tools.
- PMP certification and experience with LIMS systems are preferred.

This description highlights the essential duties and qualifications for the Vendor Laboratory Manager role at BioMarin. It is designed to attract qualified candidates by clearly outlining expectations and requirements.