Líder de Productos de Línea - Biotecnología (Especialista)

About the role

The Line Product Leader for Biotechnological products will oversee the regulatory, technical, and operational aspects of commercial biotech medicines. The role ensures compliance with national and international guidelines, guaranteeing product safety, efficacy, and market continuity.

Key responsibilities

• Assess project feasibility and evaluate raw material changes for manufacturing site shifts.
• Develop pilot batches for new primary packaging presentations.
• Manage and monitor stability studies for biotech product lines.
• Transition additional presentations to full production, both for primary containers and printed materials.
• Provide technical support and process change requests for biotech products.
• Lead quality system activities in accordance with BPFL compliance codes.
• Execute improvement projects aligned with company strategies.
• Implement changes for first production lots (contract manufacturing).
• Support projects that maintain product registrations as authorized by COFEPRIS.

Required profile

• Minimum 2 years experience in the pharmaceutical industry.
• At least 1 year of project management experience.
• Bachelor’s degree in Chemical‑Pharmaceutical or Chemical‑Biological fields.
• Knowledge of Mexican regulations NOM‑059 and NOM‑073.
• Understanding of biotechnology and new product development (INP) for pharmaceuticals.

Required skills

• NOM‑059 regulatory knowledge
• NOM‑073 regulatory knowledge
• Biotechnology expertise
• New product development (INP) experience
• Microsoft Project (desirable)
• Analytical method development
• Stability study management