Senior Upstream Bioprocess Leader | Remote & Scalable Ops

Biopharma Careers; Parma; In loco; EUR 56.000 - 68.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Relocation support

Comprehensive benefits package

Remote work options

Descrizione del lavoro

Chiesi in Parma seeks a senior leader to drive industrialization and lifecycle management of upstream biopharmaceutical processes. You will lead insourcing, tech transfer, scale‑up, and validation across development to commercial production.

The role interfaces with R&D, CDMOs, Production, Quality, and Engineering, applying QbD and ensuring alignment with FDA/EMA/ICH guidelines. A MSc/PhD and 10+ years in biologics CMC are required, with English proficiency and leadership skills.

Competenze

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or related discipline.
• At least 10 years in biopharmaceutical drug substance process development with leadership in complex biologics CMC programs.
• Strong scientific background in biologics manufacturing and bioprocess development.
• Deep expertise in upstream process development and manufacturing, including mammalian cell culture (CHO), single‑use bioreactors, centrifugation, and depth filtration.
• Proven experience in process optimization, scale‑up/down, technology transfer, and industrialization.
• GMP knowledge and global regulatory familiarity (FDA, EMA, ICH, CMC).
• Experience supporting regulatory submissions and managing manufacturing in FDA/EMA facilities.
• CDMO management experience and external development oversight.
• Product lifecycle management and commercialization strategies for biologics.
• Strong English communication skills.

Mansioni

• Providing hands‑on scientific and technical leadership in process insourcing and scale‑up activities.
• Coordinating upstream process development with internal R&D and external CMOs.
• Leading lifecycle management for commercial biotech processes and ensuring quality and supply reliability.
• Interpreting complex data to support decision making and risk mitigation.
• Applying QbD principles and contributing to control strategies and validation plans.
• Supporting regulatory submissions and representing CMC topics with health authorities.
• Designing and evaluating pilot‑scale studies for development and tech transfer.
• Collaborating with Production, Quality, Engineering, and Maintenance for validation campaigns and process implementation.
• Developing GMP documentation including batch records, risk assessments, and validation protocols.
• Providing training to Manufacturing personnel on compliant production processes.

Conoscenze

Leadership

Cross-functional collaboration

Strategic thinking

Data interpretation

Communication skills

Travel readiness

Formazione

MSc/PhD in Biotechnology or related

Descrizione del lavoro

Chiesi in Parma seeks a senior leader to drive industrialization and lifecycle management of upstream biopharmaceutical processes. You will lead insourcing, tech transfer, scale‑up, and validation across development to commercial production.

The role interfaces with R&D, CDMOs, Production, Quality, and Engineering, applying QbD and ensuring alignment with FDA/EMA/ICH guidelines. A MSc/PhD and 10+ years in biologics CMC are required, with English proficiency and leadership skills.