CRSO - Scientist/Senior Scientist/Principal Scientist, Reference Standard Scientist, Medicines Innov
2 weeks ago
Position Title:
Scientist/Senior Scientist/Principal Scientist (R1-R3), Reference Standard Scientist, Medicines Innovation Hub at LCCI
Path/Level:
R1-R3
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., M.S. or PhD in Chemistry or related field and significant pharmaceutical analysis or production experience.
Experience Requirements:
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
Strong compliance background
Location-Bengaluru India
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.
#WeAreLilly
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Bengaluru, Karnataka, India Lilly Full timeWe're looking for people who are determined to make life better for people around the world. Position Title: Scientist/Senior Scientist/Principal Scientist (R1-R3), Reference Standard Scientist, Medicines Innovation Hub at LCCI Path/Level: R1-R3 Organization Overview: At Lilly, we unite caring with discovery to make life better for people...
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Bengaluru, India Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Position Title: Scientist/Senior Scientist/Principal Scientist (R1-R3), Reference Standard Scientist, Medicines Innovation Hub at LCCI Path/Level: R1-R3 Organization Overview: At Lilly, we unite caring with discovery to make life better for people...
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Bengaluru, India Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Position Title: Scientist/Senior Scientist/Principal Scientist (R1-R3), Reference Standard Scientist, Medicines Innovation Hub at LCCI Path/Level: R1-R3 Organization Overview: At Lilly, we unite caring with discovery to make life better for people...
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