Reference Standard Scientist - Bioproduct Research and Development

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Organization 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.    In this role, you will be part of a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms.  Ideal candidates will possess experience across multiple analytical techniques, demonstrate an aptitude in technical problem-solving, and be motivated to work both independently and collaboratively in a dynamic environment.

Job Description

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 Reference Standard Scientist is responsible for ensuring the technical integrity and overall compliance of Lilly reference standards and critical related materials.  This includes establishing and maintaining reference standard batch replacement, manufacturing/packaging activities, inventory management, and evaluation testing.  The scientist will work closely within the CRSO team and with global customers to ensure efficient and timely support of reference standard material and information deliverables.

Key Responsibilities:

Technical

• Use knowledge reference standard science, analytical testing techniques, and general analytical chemistry background to solve technical problems and issues

• Establish and execute reference standard technical strategy including source material selection, packaging, specifications, statistical design, and certification of property values

• Discern the impact of new batches prepared by a new route that differs from the previously established reference standard batch

• Work as a critical team member to handle, organize, and utilize complex data sets from multiple sources to enable data driven conclusions

Project Management

• Manage the timely delivery of work associated with reference standard manufacturing, characterization, and inventory management
• Monitor existing batches and determines appropriate plans for resupply activities based on manufacturing or source batch acquisition complexity
• Participate in processes to meet global regulatory commitments associated with reference standards
• Leverage external vendors for appropriate technical deliverables
• Manage assigned internal project load, acts in a self-directed manner in anticipation of future assignments

Reference Standard Administration

• Prepare requests for source material and packaging operations to achieve timely supply of suitable material for new reference standard batches
• Disposition source materials to document suitability for use
• Maintain relationships with high-quality collaborators and vendors to meet capacity and capability required by CRSO
• Author high quality reference standard documentation including profiles and protocols in conjunction with molecule technical experts and product stewards
• Ensure that activities are complaint with all applicable regulatory and safety requirements
• Manage the process for replacement of materials that are nearing exhaustion
• Participate in all aspects of CRSO inventory management including global customer order fulfilment

Decision Making

• Provide updates to supervision regarding progress and issues
• Responsible for decisions that ensure the reliable supply of reference standard materials
• Understand and follow all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations

Influence

• Ability to persuade and gain consensus via indirect authority
• Influence CRSO partners to fully participate in the reference standard establishment and maintenance process
• Lead laboratory and molecule technical experts to resolve laboratory, manufacturing, and reference standard issues
• Ensure global customers can efficiently procure CRSO materials

Customer Focus/External Focus

• Interface with various customer groups to enable positive and continuously improving interactions
• Establish a relationship of trust with customers and partners
• Interact with customers with integrity and respect
• Seek feedback from customers regarding the quality and timeliness of services

Requirements

• B.S. in Chemistry and at least 3 years of pharmaceutical analysis or production experience; or
• M.S. in Chemistry and at least 1 year of pharmaceutical analysis or production experience.
• Strong knowledge of analytical sciences including measurement techniques, specifications, statistical analysis of data.
• Project management skillset.
• Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management.
• Ability to respond to changing priorities while maintaining accuracy and attention to detail.
• Demonstrated scientific problem-solving skills.
• Influencing and coaching skills.
• Experience with computerized inventory management.
• Strong proficiency in statistical tools (e.g., Excel and JMP).
• Strong communication skills.
• Strong compliance background.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Preferred Skills and Experience

• Experience with the science of reference standards preferred.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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