Biological E.
Website:
biologicale.com
Job details:
Function / Department : Vaccine R&D – CGT - mRNA
Position Title / Role : Lead of Analytical Development (CGT)
(Final title to be commensurate with experience)
Qualification & Experience: PhD / MSc in Analytical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, or related discipline with 10+ years of progressive experience in analytical development within biopharma, with strong focus on mRNA therapeutics / vaccines.
Extensive experience in analytical development across Drug Substance (DS) and Drug Product (DP). Proven expertise in method development, qualification, validation, and release testing for IND/CTA and commercial readiness. Experience in Lentiviral vector analytics (titer, potency, safety assays) is highly desirable. Strong background in CMC development and regulatory submissions
Job Location : Genome Valley, Shameerpet, Hyderabad
Main purpose of the Job:
The Head of Analytical Development will provide strategic and technical leadership for analytical sciences supporting mRNA-based therapeutics and vaccines, with adjacency to Lentiviral vector programs within CGT.
The role is accountable for developing, validating, and implementing robust analytical methods for characterization, release, and stability testing of Drug Substance (DS) and Drug Product (DP), ensuring successful translation from research to clinical and commercial manufacturing.
Job responsibilities:
Analytical Strategy & Leadership
- Define and execute the analytical development strategy for mRNA platforms across DS and DP
- Establish phase-appropriate analytical frameworks supporting discovery and development
- Drive development of state-of-the-art analytical capabilities for mRNA characterization and QC release
Analytical Development (DS & DP)
- Lead development, optimization, and validation of analytical methods for mRNA Drug Substance, including:
- Identity, purity, integrity (e.g., fragmentation, truncation)
- Capping efficiency, poly(A) tail characterization
- Residual impurities (DNA template, enzymes, dsRNA, contaminants)
- Oversee analytical methods for Drug Product:
- LNP characterization (size, PDI, encapsulation efficiency)
- Potency and functional assays
- Stability-indicating methods
- Ensure method robustness, transferability, and lifecycle management
Release Testing & Quality Control
- Establish and oversee release testing strategies for DS and DP aligned with regulatory expectations
- Define specifications, control strategies, and acceptance criteria
- Ensure readiness for GMP QC testing environments, including tech transfer to QC labs
- Support batch release, comparability, and stability programs
CMC & Regulatory Support
- Provide analytical leadership for IND/CTA submissions, including:
- Method validation reports
- Specifications and justification
- Analytical sections of regulatory filings
- Collaborate with Regulatory, QA, and Manufacturing teams to ensure compliance and inspection readiness
- Support process characterization and comparability studies
Lentiviral & CGT Analytical Capabilities (Adjacent Scope)
- Oversee or guide analytical development for Lentiviral vectors, including:
- Viral titer (physical and functional)
- Potency and infectivity assays
- Safety assays (RCL, residual host cell DNA/proteins)
- Enable harmonization of analytical approaches across mRNA and viral vector platforms
Method Transfer & Manufacturing Support
- Lead analytical method transfer from R&D to GMP QC and external CDMOs
- Support technology transfer and scale-up
- Troubleshoot analytical challenges during manufacturing and scale-up
People & Organizational Leadership
- Build and lead a high-performing team of analytical scientists
- Foster a culture of scientific rigor, compliance, and innovation
- Develop organizational capabilities in analytical sciences for CGT
External Engagement & Innovation
- Evaluate emerging analytical technologies and platforms (e.g., advanced sequencing, digital PCR, single-particle analysis)
- Manage external collaborations with CDMOs, CROs, and technology providers
- Support due diligence and in-licensing from an analytical/CMC perspective
Candidate desired skills:
Technical Expertise
- Deep expertise in analytical development for mRNA therapeutics/vaccines
- Strong experience in:
- Chromatography (HPLC/UPLC)
- Electrophoresis (CE, gel-based methods)
- PCR-based methods (qPCR, ddPCR)
- Sequencing and RNA characterization tools
- Proven experience in LNP analytics and formulation characterization
- Working knowledge of Lentiviral vector analytics
- Strong understanding of ICH guidelines, GMP, and regulatory expectations
Leadership & Strategic Skills
- Ability to build scalable analytical platforms aligned to pipeline needs
- Strong strategic thinking with end-to-end CMC understanding
- Effective decision-making in complex and evolving environments
Collaboration & Communication
- Strong cross-functional collaboration with Process Development, Manufacturing, Regulatory, and QA
- Ability to communicate complex analytical data to senior leadership
- Experience managing internal and external stakeholders
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