Lead of Analytical Development (CGT)
Biological E. Limited is seeking a Lead of Analytical Development for their Vaccine R&D - CGT department in Hyderabad. This role provides strategic leadership for mRNA therapeutics and Lentiviral vector analytical programs, covering everything from method development to CMC regulatory submissions. The incumbent will lead a team of scientists, manage external collaborations, and ensure robust QC release strategies. It requires deep technical expertise in biopharma analytical methods and extensive experience with GMP regulatory standards.
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Experience
10+ years
Function
Research
Work mode
Onsite, India
Company
Tier 2
What you will work on
Biological E. Limited is seeking a Lead of Analytical Development for their Vaccine R&D - CGT department in Hyderabad. This role provides strategic leadership for mRNA therapeutics and Lentiviral vector analytical programs, covering everything from method development to CMC regulatory submissions. The incumbent will lead a team of scientists, manage external collaborations, and ensure robust QC release strategies. It requires deep technical expertise in biopharma analytical methods and extensive experience with GMP regulatory standards.
TAL's take
High-impact leadership role in vaccine R&D with clear responsibility for mRNA and CGT analytical platforms.
The JD is extremely well-defined, mapping specific analytical methodologies to mRNA and viral vector therapeutic development.
Must haves
- 10+ years progressive experience in analytical development within biopharma
- Strong focus on mRNA therapeutics or vaccines
- Expertise in method development, qualification, validation, and release testing
- Proven experience in LNP analytics and formulation characterization
- Deep understanding of ICH guidelines and GMP regulations
- Proven leadership in CMC development and regulatory submissions
Tools and skills
Nice to have: lentiviral vector analytics, sequencing, digital pcr, single-particle analysis.
About the company
Established biopharmaceutical company with significant vaccine manufacturing presence in India.
Posts mentioning Biological E. Limited
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