Chemistry Analytical Scientist at Lilly – BSc & MSc Apply Online
Analytical Scientist-Corporate Reference Standard Organization
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full Time Regular
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 a 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 compliant 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 in the 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.
Apply Now: APPLY ONLINE HERE
Keywords: Lilly job posting, Analytical Scientist, Reference Standard Organization, Corporate, Pharmaceutical, Chemistry, Project Management. Chemistry Analytical Scientist at Lilly – BSc & MSc Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
