Advisor, Reference Standards, BR&D

Eli Lilly and Company; Indianapolis (IN); On-site; USD 80,000 - 140,000; Full time

Job summary

An established industry player seeks a dedicated Technology Leader for the Corporate Reference Standards Organization. This pivotal role involves overseeing the production and management of pharmaceutical reference standards, ensuring compliance with quality systems and regulatory requirements. You will lead a team to enhance operational efficiency and customer service while managing complex projects. If you are passionate about making a significant impact in the healthcare sector and thrive in a collaborative environment, this opportunity is for you. Join a forward-thinking organization that values innovation and quality in delivering life-changing medicines.

Benefits

Health Insurance

Retirement Plan

Paid Time Off

Professional Development Opportunities

Flexible Work Hours

Employee Assistance Program

Qualifications

• Advanced degree in science or engineering preferred with experience in processes and facilities.
• Extensive experience with reference standard and sample management is a plus.

Responsibilities

• Manage pharmaceutical reference standard and stability management operations.
• Supervise CRSO and sample management materials team, ensuring compliance and quality.
• Lead investigations of quality standard deviations and implement improvements.

Skills

Pharmaceutical Reference Standards Management

Analytical Control Systems

Project Management

Problem-Solving Skills

Communication Skills

Database Management

Education

Advanced Degree in Science or Engineering

Tools

cGMP Quality Systems

Inventory Management Systems

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview:

The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities.

Position Summary:

The Corporate Reference Standards Organization (CRSO) is responsible for all corporate reference standards used at Lilly. CRSO establishes corporate technical strategy and performs or coordinates the steps required to supply laboratories with approved reference standard materials and supporting data. Activities include specification and acquisition of source material, source batch candidate disposition, formulation and package development/execution, inventory management, order fulfilment, design of analytical testing protocols, evaluation of characterization data, creation and documentation of technical rationale for all decisions, and certification of profiles for reference standards. The result is a consistent supply of accurately defined standards that are demonstrated to be suitable for use in development and commercial global product testing applications.

The CRSO Technology leader is responsible for a wide range of key CRSO processes. These include activities such as reference standard manufacturing, packaging, labeling, receipt, inventory management, customer order processing, material dispensing, global cold-chain shipping, facility/equipment management, and work-process tracking and optimization. This leader will also be responsible for the Development Stability Management (DSM) team which executes stability study builds, daily sample pulls, stability sample receipt, and storage of clinical-supply-mode samples.

Deliverables will be achieved working with direct reports and by leveraging significant resources outside the CRSO and DSM organizations, including a network of on-site and external contract vendors. The leader is also responsible for special projects to improve CRSO and DSM quality, efficiency, and customer service.

The individual will influence all phases of drug development, product registration and marketed product support by ensuring that high quality, suitable reference standards needed for analytical control strategies are appropriately produced, stored, and distributed. The individual must ensure that the CRSO and DSM quality systems are compliant with all corporate and external regulatory requirements.

Responsibilities:

Functional and Technical Expertise

• Responsible for all aspects of pharmaceutical reference standard and stability management operations, processes, and quality systems
• Manage standard and sample inventory management, order fulfillment, global distribution, and the associated equipment and facilities
• Manage relationships with internal customers and partners
• A primary contact for internal and external audits
• Create and maintain the associated cGMP quality systems
• Ensuring facilities and equipment are adequately maintained.

Leadership

• Supervise the employees in the CRSO and sample management materials team
• Ensure that business, compliance, regulatory, quality, environmental, and safety requirements are followed
• Execute capital projects for facilities and equipment to ensure adequate storage space for long-term growth
• Design and communicate key performance metrics, with overall accountability for successful execution of the metrics
• Lead investigations of departures from quality standards
• Seek out and implement novel approaches for continuous improvement
• Influence internal and external leaders in areas of critical impact for CRSO and sample management
• Monitor and influence external environment

Basic Requirements:

• Advanced degree in science, engineering, or related field preferred with significant experience establishing and maintaining processes, facilities, and equipment for a large chemical and biologic inventory.

Additional Preferences:

• Extensive experience with reference standard and sample management
• Understanding of pharmaceutical analytical control systems
• Demonstrated problem-solving skills
• Demonstrated computer skills, particularly in working with databases
• Ability to manage multiple complex projects concurrently
• Self-management skills
• Excellent communication skills, both oral and written
• Ability to influence others outside of a direct reporting relationship

Additional Information:

• Travel: 5 to 15%
• Potential exposure to chemicals, allergens, and loud noises.
• Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)