Lead - CMC Biopharmaceuticals ( Cell & Gene Therapy )

JOB DESCRIPTION

Job title : Lead – CMC Biopharmaceuticals | (Gene Therapy)

Reports to : VP - Operations

Job purpose

The Lead – CMC will provide technical and regulatory leadership for Chemistry, Manufacturing & Controls (CMC) activities supporting cell therapy, gene therapy, and advanced biopharmaceutical products intended for US FDA regulatory submissions and commercialization. This role will lead end-to-end CMC strategy, process development, GMP manufacturing support, and regulatory authoring for IND, BLA, and post-approval submissions. The position requires strong expertise in FDA expectations for biologics, viral vectors, and advanced therapy medicinal products (ATMPs), including lifecycle management, comparability, validation, and inspection readiness. The ideal candidate will have extensive experience of manufacturing process of biologics and advanced therapies with a strong understanding of 21 CFR regulations, cGMP requirements, FDA guidance documents, and global CMC compliance frameworks.

Duties and responsibilities

1. CMC Strategy

• Develop and execute CMC strategies aligned with US FDA regulatory expectations for cell and gene therapy products.
• Lead preparation and review of:

IND submissions

• BLA submissions
• Amendments and annual reports
• FDA information requests and deficiency responses
• Ensure CMC documentation complies with:
• 21 CFR Parts 210, 211, 600 series
• ICH guidelines
• FDA guidance for gene therapy and cell therapy products
• Representing CMC function during FDA meetings including:
• Pre-IND
• INTERACT
• Type B meetings
• Pre-BLA discussions

2.Process Development & GMP Manufacturing

• Lead development and optimization of manufacturing processes for:
• AAV vectors
• Recombinant biologics
• Support process scale-up, characterization, and validation activities.
• Ensure manufacturing readiness for clinical and commercial production.
• Oversee technology transfer activities to internal manufacturing sites and CDMOs.
• Ensure compliance with aseptic processing and contamination control requirements.

3.Analytical Development & Product Characterization

• Guide development, qualification, and validation of analytical methods.
• Ensure robust characterization for Identity, Purity, Potency, Safety and Stability
• Support reference standard qualification and comparability assessments.
• Lead stability strategy development in accordance with FDA and ICH expectations.

Qualifications and Experience

• Ph.D. / MS in Biotechnology, Biochemical Engineering or related field
• Around 15years of relevant CMC experience in biopharmaceuticals.
• Significant experience supporting US FDA submissions for biologics and/or advanced therapies.
• Hands-on experience with cell and gene therapy platforms preferred.
• Prior experience interacting with FDA reviewers and inspectors strongly preferred.
• Experience in clinical-stage and commercial-stage biologics development is desirable.

Required Technical Expertise

1. Regulatory Knowledge

Strong understanding of:

• US FDA biologics regulations
• 21 CFR Parts 210/211/600
• FDA guidance for:
• Human gene therapy
• Cellular therapy products
• Viral vector manufacturing
• ICH Q5/Q6/Q7/Q8/Q9/Q10/Q11 guidelines
• Comparability and lifecycle management expectations

2.Technical Expertise

• Viral vector process development
• Cell culture and bioreactor systems
• Downstream purification processes
• Aseptic manufacturing
• Analytical characterization techniques
• Process validation and CPV
• Stability and reference standard programs
• Tech transfer and scale-up activities.

Working conditions

This position operates in an office setting,in person.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Direct Reports

N/A