Reference Standard and Development Stability 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 a senior technical leader within a diverse team of analytical chemists, pharmaceutical scientists, and engineers delivering product and process understanding across a broad range of platforms. Ideal candidates will bring deep expertise across multiple analytical techniques, a proven record of solving complex technical problems, and the ability to lead both independently and through others 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 and Development Stability Scientist is a senior technical leader responsible for the technical integrity and overall compliance of Lilly development stability studies, reference standards, and critical related materials. The scientist influences all phases of drug development, product registration, and marketed product support by ensuring that development stability studies are properly designed and managed and that suitable reference standards are available and accurately assigned. The individual sets technical direction so that materials and certifying documentation are scientifically sound, integrated with analytical control strategies, and compliant with all corporate and regulatory requirements. The scientist partners with global Lilly scientists, quality, and regulatory leaders to ensure efficient and timely support of material and information deliverables, and serves as a technical resource and mentor within CRSO.

Key Responsibilities

Technical

• Apply expert knowledge of reference standard and stability science to resolve complex, high-impact technical problems, including issues that span multiple molecules, modalities, or sites

• Own and continuously improve the reference standard and stability quality system and associated business processes

• Set technical strategy for source material selection, packaging design, inventory management, equipment and facilities, protocol design, and specifications, grounded in a deep understanding of analytical control strategies

• Lead global technical teams to handle, organize, and interpret complex data sets from multiple sources and reach information-driven conclusions

• Define statistical approaches and calculations, and make technical conclusions that support key analytical testing and suitability decisions

• Shape and meet global regulatory commitments associated with reference standards and stability studies, including contributing to regulatory submission content and agency responses

• Monitor evolving regulatory guidance and industry practice for reference standards and stability, and translate changes into CRSO strategy

Project Management

• Independently lead a portfolio of complex projects and deliver work on time with minimal oversight

• Establish strategic plans for material supply, storage, and distribution based on material properties, intended use, and portfolio needs

• Define metrics, evaluate trends, and drive appropriate corrective and preventive actions

• Leverage internal and external vendors for technical deliverables and required capacity, and oversee vendor performance

• Anticipate future business needs and proactively shape project priorities

• Author and review high-quality technical documentation in conjunction with molecule technical experts, product stewards, and statisticians

• Ensure that activities are compliant with all applicable regulatory and safety requirements

Decision Making

• Make and defend technical decisions with broad impact on reference standard and stability programs, escalating to leadership when appropriate

• Provide clear updates to leadership and relevant stakeholders on progress, risks, and issues

• Understand and follow all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations

Influence

• Persuade and gain consensus across functions and sites through indirect authority

• Influence CRSO internal and external partners to fully participate in technical decision making

• Lead laboratory and molecule technical experts to resolve complex technical issues

• Coach and mentor less experienced scientists to build reference standard and stability capability across CRSO

• Ensure global customers can efficiently procure materials

Impact

• Coordinate solutions involving multiple laboratories and business units

• Prevent interruptions in deliverables by planning the timely initiation and efficient execution of projects

• Communicate critical information to chemists, quality leaders, regulatory representatives, and key collaborators in a timely manner

• Work with outside sources to obtain material

• Represent CRSO in cross-functional forums and contribute to broader analytical and quality strategy

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

• PhD in Chemistry and at least 3 years of pharmaceutical analysis or production experience; or

• M.S. in Chemistry and at least 5 years of pharmaceutical analysis or production experience; or

• B.S. in Chemistry and at least 8 years of pharmaceutical analysis or production experience.

• Expert knowledge of analytical sciences including measurement techniques, specifications, and statistical analysis of data.

• Demonstrated experience with the science of reference standards and/or stability.

• Proven record of leading complex projects and cross-functional teams.

• Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management.

• Ability to set and adjust priorities in a changing environment while maintaining accuracy and attention to detail.

• Demonstrated ability to solve complex scientific problems.

• Strong influencing, coaching, and mentoring skills.

• Experience with computerized inventory management and LIMS systems.

• Advanced proficiency in statistical tools (e.g., Excel and JMP).

• Excellent written and verbal communication skills, including with senior leaders and regulatory audiences.

• Strong compliance background.

Preferred Skills and Experience

• Experience with the science of reference standards strongly preferred.

Travel Requirements

• Estimated up to 15% overnight travel for business.

Additional Information

• Potential exposure to chemicals, allergens, extreme temperatures, and loud noises.

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 $129,000 - $246,400

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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