Chemistry Analytical Scientist at Eli Lilly! Apply Online

Chemistry Analytical Scientist at Eli Lilly! Apply Online

Chemistry Analytical Scientist at Eli Lilly! Apply Online. Interested and eligible applicants can check out all of the details on the same below:

Analytical Scientist – Corporate Reference Standard Organization

Location: Bangalore, Karnataka, India

Category: Research & Development

Job Type: Full-Time Regular

Job ID: R-71433

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 and order fulfillment.
• Design of analytical testing protocols.
• Evaluation of characterization data.
• Creation and documentation of technical rationale for all decisions.
• Certification of profiles for reference standards.

The result is a consistent supply of accurately defined standards demonstrated to be suitable for use in development and commercial global product testing applications.

The Reference Standard Coordinator ensures the technical integrity and compliance of Lilly reference standards and critical related materials. Responsibilities include establishing and maintaining reference standard batch replacement, manufacturing activities, inventory management, and evaluation testing. The coordinator works closely

within the CRSO team and with global customers to ensure efficient and timely support of reference standard information deliverables.

Key Responsibilities:

Technical:

• Utilize knowledge of reference standards science and a strong technical background to solve problems and issues.
• Establish reference standard potency calculations and assignments.
• Discern the impact of new batches prepared by different routes compared to established standards.
• Handle, organize, and utilize complex data sets from multiple sources to enable data-driven conclusions.

Project Management:

• Manage timely delivery of work related to reference standard manufacturing, characterization, and inventory management.
• Monitor existing batches and plan resupply activities based on manufacturing or source batch acquisition complexity.
• Participate in processes to meet global regulatory commitments related to reference standards.
• Leverage external vendors for technical deliverables.
• Manage assigned internal project loads in a self-directed manner anticipating future assignments.

Reference Standard Administration:

• Prepare requests for source material and manage the process to ensure timely supply of suitable materials for new reference standard batches.
• Document the disposition of source materials to verify their suitability for use.
• Maintain relationships with high-quality collaborators and vendors to meet CRSO capacity and capability requirements.
• Author high-quality reference standard documentation, including profiles and protocols, in conjunction with molecule technical experts and product stewards.
• Ensure compliance with all applicable regulatory and safety requirements.
• Manage the replacement process for materials nearing exhaustion.
• Oversee all aspects of CRSO inventory management, including global customer order fulfillment.

Decision Making:

• Provide updates to supervision regarding progress and issues.
• Make decisions to ensure the reliable supply of reference standard materials.
• Adhere to all relevant policies, including business, compliance, regulatory, quality, environmental, and safety expectations.

Influence:

• Persuade and gain consensus through indirect authority.
• Influence CRSO partners to fully engage 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 efficiently procure CRSO materials.

Customer Focus/External Focus:

• Interface with customer groups to foster positive and improving interactions.
• Build trust and establish strong relationships with customers and partners.
• Interact with integrity and respect while seeking customer feedback on quality and timeliness of services.

Educational Requirements:

• B.S. or M.S. in Chemistry or related field with significant pharmaceutical analysis or production experience.

Experience Requirements:

• 1-5 years of relevant experience in the pharmaceutical domain.
• Strong knowledge of analytical sciences, measurement techniques, specifications, and statistical analysis.
• Project management skills.
• Experience with reference standards science preferred.
• Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management.
• Ability to adapt to changing priorities while maintaining accuracy and attention to detail.
• Demonstrated scientific problem-solving skills.
• Influencing and coaching skills.
• Experience with computerized inventory management.
• Proficiency in statistical tools (e.g., Excel and JMP).
• Strong communication skills.

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