Reference Standard and Development Stability Scientist - Bioproduct Research and Development

Eli Lilly and Company • Us, IN

3d

About The Position

The Reference Standard and Development Stability Scientist is a senior technical leader in Lilly’s Bioproduct Research and Development organization and Corporate Reference Standards Organization (CRSO). The role is responsible for the technical integrity and overall compliance of development stability studies, reference standards, and related critical materials. It influences drug development, product registration, and marketed product support by ensuring that stability studies are properly designed and managed and suitable reference standards are available and accurately assigned.

The scientist sets technical direction to ensure materials and certifying documentation are scientifically sound, aligned with analytical control strategies, and compliant with corporate and regulatory requirements. The role partners with global scientists, quality, and regulatory leaders to deliver material and information support efficiently and on time, and serves as a technical resource and mentor within CRSO.

CRSO establishes corporate technical strategy and performs or coordinates the work needed to supply laboratories with approved reference standards and supporting data. Its activities include source-material specification and acquisition, candidate disposition, formulation and packaging, inventory management, order fulfillment, analytical protocol design, characterization-data evaluation, technical rationale documentation, and certification of reference-standard profiles.

Requirements

• PhD in Chemistry and at least 3 years of pharmaceutical analysis or production experience; or an M.S. in Chemistry and at least 5 years of such experience; or a B.S. in Chemistry and at least 8 years of such experience.
• Expert knowledge of analytical sciences, including measurement techniques, specifications, and statistical analysis of data.
• Demonstrated experience with reference-standard science 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 such as Excel and JMP.
• Excellent written and verbal communication skills, including communication with senior leaders and regulatory audiences.
• Strong compliance background.

Nice To Haves

• Experience with the science of reference standards is strongly preferred.

Responsibilities

• Resolve complex, high-impact technical problems in reference-standard and stability science, including issues spanning 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.
• Lead global technical teams in organizing and interpreting complex data from multiple sources and reaching evidence-based conclusions.
• Define statistical approaches and calculations and make technical conclusions supporting analytical testing and suitability decisions.
• Shape and meet global regulatory commitments for reference standards and stability studies, including contributing to submission content and agency responses.
• Monitor changes in regulatory guidance and industry practice and translate them into CRSO strategy.
• 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.
• Use internal and external vendors for technical deliverables and capacity, and oversee vendor performance.
• Anticipate future business needs and proactively shape project priorities.
• Author and review technical documentation with molecule technical experts, product stewards, and statisticians.
• Make and defend technical decisions with broad impact, escalating to leadership when appropriate.
• Provide leadership and stakeholders with clear updates on progress, risks, and issues.
• Follow relevant business, compliance, regulatory, quality, environmental, and safety policies and expectations.
• Build consensus across functions and sites through influence and indirect authority, and engage CRSO partners in technical decision making.
• Lead laboratory and molecule technical experts in resolving complex technical issues.
• Coach and mentor less experienced scientists to build reference-standard and stability capability across CRSO.
• Help global customers procure materials efficiently and coordinate solutions across laboratories and business units.
• Plan timely project initiation and execution to prevent interruptions in deliverables.
• Communicate critical information promptly to chemists, quality leaders, regulatory representatives, and collaborators.
• Work with outside sources to obtain material and represent CRSO in cross-functional forums, contributing to broader analytical and quality strategy.
• Interface with customer groups, build trust with customers and partners, act with integrity and respect, and seek feedback on service quality and timeliness.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior