Business Development Manager

Globyz Biopharma Services; Buffalo (NY); On-site; USD 90,000 - 140,000; Full time

Job summary

Globyz Biopharma Services seeks a seasoned sourcing professional to drive new business for Clinical Trials Materials and Comparators. You will lead supply planning, forecast budgets, and coordinate with internal teams and external vendors to ensure timely, compliant CTM delivery across trials.

Key responsibilities include overseeing CTM manufacturing requests at GMP facilities, managing inventory, and ensuring regulatory compliance with FDA/ICH/GMP standards.

Qualifications

• Minimum of 5 years life sciences experience, including labeling, packaging and distribution of clinical trial materials.
• Experience managing labeling, packaging and distribution of materials to clinical sites.
• Knowledge of FDA, ICH, GMP, and other regulatory requirements.
• Demonstrated understanding of pharmaceutical processes, packaging operations and drug development.
• Familiarity with IND/NDA requirements and ability to present complex issues clearly.

Responsibilities

• New Business Development for Clinical Trials Material/Comparators.
• Lead development of Clinical Supply Demand Gathering and Supply Plans.
• Communicate clinical trial requirements to internal stakeholders and external partners.
• Manage vendor relationships where required.
• Oversee manufacture requests for CTM at GMP packaging facility and manage trial inventory.

Skills

Life sciences experience

Project management

Multi-disciplinary teamwork

Stakeholder communication

Tools

MS Office Suite

Word

Excel

PowerPoint

Windows

Job description

Globyz Comparator And Clinical Supplies Sourcing

• USA
• New York/New Jersey/Pennsylvania
• Posted 2 years ago

Website Globyz Comparator And Clinical Supplies Sourcing

Our sourcing specialists utilize a global network of leading manufacturers and major wholesalers to provide cost-effective access to virtually any product, any quantity, even the most difficult to source items. Supported by our global warehousing and distribution network, Globyz Biopharma Services can also ensure fast delivery practically anywhere in the world.

Job Description

• New Business Development for Clinical Trials Material /Comparators
• Lead in the development of Clinical Supply Demand Gathering and Supply Plans
• Effectively communicate clinical trial requirements to internal stakeholders and external partners to execute the supply plan
• Manage Vendor relationships where required
• Initiate and see through requests for the manufacture of CTM at the GMP packaging facility and manage trial inventory throughout
• Accurately forecast and track supply chain budgets
• Track and report current clinical supplies activities by study
• Create and finalize packaging/labeling production schedules and identify and resolve any discrepancies/issues
• Track the reconciliation, disposition, and destruction of all clinical supplies materials and related communications and reports.

Qualifications

• Minimum of 5 years life sciences experience, including a minimum of 3 years experience in labeling, packaging and distribution of clinical trial materials
• Must have experience in the management of labeling, packaging and distribution of materials to clinical sites
• Knowledge of FDA, ICH, GMP, and other regulatory requirements
• Demonstrated knowledge of current pharmaceutical processes, packaging operations and drug development processes
• Knowledge of clinical supply aspects of IND/NDA requirements; ability to present complex issues in oral and written form
• Strong project management abilities.
• Demonstrated ability to contribute successfully in a multi-disciplinary team environment organization.
• Well versed in Windows, MS Office, Word, Excel, Power Point and other related computer software