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Principal Scientist – Analytical

5-10 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Full Time Education: 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 Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.