Job Title:
Principal Scientist – Analytical
Location: Bangalore, Karnataka, India
Category: Research & Development
Job Type: Full-Time, Regular
Job ID: R-91381
Company Overview:
Eli Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, USA, with over 39,000 employees worldwide. Our mission is to make life better for people around the world through innovative medicines, scientific discovery, and compassionate care.
The Lilly Capability Center India (LCCI) in Bengaluru is a strategic hub for scientific and technical talent, supporting global R&D operations, including Product Research and Development (PRD).
Department Overview – Product Research & Development (PRD):
PRD is responsible for the development and commercialization of:
Small molecules
Insulins
Monoclonal antibodies
Novel therapeutic proteins
Peptides
Oligonucleotides
Gene therapy systems
Within PRD, this role will specifically support Synthetic Molecule Design and Development (SMDD) and Bioproduct Research and Development (BRD) analytical teams.
Role Summary:
The Principal Scientist - Analytical will contribute to the development, evaluation, and support of analytical methods for both clinical and commercial drug products across a diverse molecule portfolio (small molecules, biologics, peptides, oligonucleotides, etc.).
Key Responsibilities:
1. Analytical Method Development & Execution
Develop, qualify, validate, and transfer analytical methods for oral and parenteral drug products.
Perform stability studies for APIs and drug products.
Design and manage testing plans for raw materials and excipients.
2. Technical Expertise
Proficient in analytical techniques such as:
HPLC, GC, CE-SDS, SEC, ELISA, qPCR, DSC, UV, LC-MS, Karl Fischer, Bioassay, Dissolution, Disintegration, X-ray diffraction, etc.
In-depth understanding of compendial methods and regulatory expectations.
Troubleshoot complex analytical and instrumentation issues.
3. Product Coverage
Analytical expertise must include at least one of the following:
Antibodies / bifunctional / fusion proteins
Peptides / oligonucleotides / genetic medicines
Small molecules / synthetic drugs
Raw materials and packaging materials
4. Quality, Compliance & Documentation
Adhere to cGMP, regulatory, quality, environmental, and safety policies.
Conduct and document root cause investigations (OOT, OOS) and implement CAPAs.
Author and review regulatory documents and lab records using tools such as:
Empower, NuGenesis, Signals (eLN)
5. Cross-functional Collaboration
Collaborate with global partners across geographies.
Support regulatory inspections, audits, and inspection readiness activities.
Author, review, and track change controls.
6. Data Analytics & Reporting
Analyze, interpret, and trend data using modern digital tools.
Proficiency in tools like Power BI, Python, and databases is a plus.
Required Qualifications:
M.S. in Chemistry/Pharmacy/Analytical Sciences with 5–8 years of experience
OR
B.S. in a related field with 7–10 years of experience
Background in analytical development for APIs or Drug Products for clinical or commercial use
Desired Attributes:
Strong problem-solving and technical decision-making skills
Ability to work independently and manage project deliverables
Effective communication and cross-cultural collaboration
Experience in authoring regulatory documentation and managing compliance
Additional Information:
Equal Opportunity: Lilly is committed to diversity and inclusion in the workplace.
Accommodation Support: Accommodation Request Form is available for candidates requiring assistance during the application process.
#WeAreLilly
Join us to be part of a team that values scientific rigor, quality, innovation, and a patient-first mindset.
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