Job Description

IMP Operations

Position Overview:

The IMP Operations team maintains a worldwide network of external contract manufacturing sites which supply investigational radiopharmaceutical medicinal products (IMP) for numerous global clinical trials. This role will support the oversight and maintenance of Lilly’s IMP external vendor network to ensure the uninterrupted continuity of cGMP manufacturing and IMP supply worldwide. Key responsibilities will involve supporting the IMP Operations team with the following activities: building and maintaining close relationships with manufacturing site partners, overseeing manufacturing projects, supporting site qualification activities, monitoring site performance, and driving rapid issue resolution. This is a highly cross-functional role which will require close collaboration with the Technical Operations, Supply Chain, Quality, Regulatory, Project Management, Analytical Development, and Radiopharmaceutical Development groups within Lilly Avid. The successful candidate must be an enthusiastic self-starter who is highly detail-oriented, organized, and results driven.

Responsibilities:

• Support the conduct of routine meetings with external manufacturing sites in conjunction with internal cross-functional groups. Prepare and distribute agendas and meeting minutes.
• Track manufacturing site performance; promptly communicate and escalate manufacturing issues to ensure rapid resolution.
• Support the timely preparation and review of relevant manufacturing documents and quality records associated with cGMP manufacturing operations such as change controls, investigations, specifications, procedures, validation protocols, analytical methods, reports, etc.
• Partner closely with the Project Management group to prepare, maintain, and communicate project timelines and workplans, where appropriate.
• Perform invoice reconciliation and other financial accounting associated with IMP manufacturing projects, as needed.
• Prepare and present IMP manufacturing updates at regular internal work group and team meetings; support the preparation of presentation materials for Avid senior leadership, when required.
• Assume additional responsibilities supporting the broader IMP Operations and CMC Development groups, as needed.
• Demonstrate a commitment to developing around Avid's core competencies: cultivates innovation, drives engagement, ensures accountability, plans and aligns, nimble learning, and manages complexity.

Required Qualifications:

• BS degree or higher in chemistry, analytical chemistry, biochemistry, molecular biology, chemical engineering, or equivalent discipline.
• At least 3 years of functional CMC experience within the biotechnology or pharmaceutical development industries.

Desired Qualifications:

• Familiarity with cGMPs as well as US, European, Japanese, Chinese, and ICH regulations and industry standards for pharmaceutical manufacturing.
• Experience within a CMC/cGMP role in the radiopharmaceutical industry.
• Familiarity with collaborative project management tools such as Microsoft Project, Smartsheet, Monday, Jira, etc.
• Solid understanding of pharmaceutical manufacturing and release within a cGMP environment.
• Experience with management of external contract manufacturing and/or testing vendors.
• Excellent interpersonal, verbal, and written communication skills with the ability to work with uncertainty and to resolve conflict in a constructive manner.
• Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.
• Must be proficient in the Microsoft 365 environment.

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