Analytical Scientist-Corporate Reference Standard Organization

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.

Organization Overview:

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, USA. Our 39,000 employees worldwide 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.

The Medicines Innovation Hub (MIH) strives to discover, develop, and deliver creative medicines to patients through the development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world. This group drives innovation in the process development and product design through the efficient combination of domain expertise coupled with lab experimentation, computational modeling, automation, data sciences, and data rich experimentation.

The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a MIH team that works closely with the MIH team in Indianapolis in enabling the delivery of Lilly’s portfolio.

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 Coordinator 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 activities, inventory management, and evaluation testing.  The coordinator will work closely within the CRSO team and with global customers to ensure efficient and timely support of reference standard information deliverables.

Key Responsibilities:

Technical

• Uses knowledge of the science of reference standards and s strong technical background to solve technical problems and issues
• Establish reference standard potency calculations and assignments
• Discerns 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

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

Reference Standard Administration

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

Decision Making

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

Influence

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

Customer Focus/External Focus

• Interfaces with various customer groups in order to allow for positive and continuously improving interactions
• Establishes a relationship of trust with customers and partners
• Interacts with customers with integrity and respect
• Seeks feedback from customers regarding the quality and timeliness of services

Educational Requirements: 

B.S., and or M.S. in Chemistry or related field and significant pharmaceutical analysis or production experience.

Experience Requirements: 

• Must have about 1-5 Years of relevant experience of pharmaceutical domain.
• Strong knowledge of analytical sciences including measurement techniques, specifications, statistical analysis of data
• Project management skillset
• Experience with the science of reference standards preferred
• 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

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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