Lead Scientist, Upstream Biological Process

Jobtailor; Parma; In loco; EUR 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

Jobtailor in Parma seeks an experienced bioprocess development leader to drive insourcing, tech transfer, and scale‑up of commercial biologics processes. You will coordinate upstream development with R&D and CMOs to ensure GMP compliance and lifecycle management.

The role emphasizes QbD, robust processes, and seamless regulatory submissions within FDA/EMA frameworks to secure reliable supply.

Competenze

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline.
• At least 10 years of experience in biopharmaceutical drug substance process development.
• Strong scientific background in biologics manufacturing and bioprocess development.
• Upstream bioprocess development including CHO culture, single‑use bioreactors, centrifugation, depth filtration.
• GMP knowledge and experience with global regulatory frameworks (FDA, EMA, ICH, CMC).
• Experience supporting regulatory submissions and managing manufacturing in FDA/EMA‑approved facilities.
• Ability to manage CDMO partnerships and external development activities.
• English language skills, written and spoken.

Mansioni

• Provide hands‑on leadership in process insourcing, tech transfer, scale‑up and validation.
• Coordinate upstream process development, optimization, and industrialization with R&D and CMOs.
• Lead lifecycle management for commercial biotech processes ensuring quality and supply reliability.
• Assess complex data to support decisions, risk mitigation, and resource planning.
• Apply QbD principles and contribute to process characterization, control strategies, and validation plans.
• Support regulatory submissions (MAA, NDA, BLA, JNDA).
• Design, execute, and evaluate pilot-scale studies for development and tech transfer.
• Collaborate with Production, Quality, Engineering, and Maintenance on feasibility studies, validation campaigns, IQ/OQ/PQ, and implementation.
• Support GMP documentation: batch records, risk assessments, validation protocols, and reports.
• Provide theoretical and practical training to Manufacturing staff.

Conoscenze

Bioprocess development

QbD principles

Tech transfer

Scale-up

GMP compliance

Regulatory knowledge

CDMO management

Biologics manufacturing

English proficiency

Formazione

MSc/PhD in Biotechnology or related

Descrizione del lavoro

• Providing hands‑on scientific and technical leadership in process insourcing, technology transfer, scale‑up, and validation activities
• Coordinating upstream process development, optimization, and industrialization activities with internal R&D teams and external CMOs
• Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability
• Assessing and interpreting complex scientific data to support decision‑making, risk mitigation, resource allocation, and program strategy
• Applying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans
• Supporting regulatory submissions (MAA, NDA, BLA, JNDA)
• Designing, executing, and evaluating pilot‑scale studies to support process development, optimization, scale‑up, and technology transfer activities
• Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation
• Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports
• Delivering theoretical and practical training to Manufacturing personnel

Requirements

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline
• At least 10 years of experience in biopharmaceutical drug substance process development
• Strong scientific background in biologics manufacturing and bioprocess development
• Deep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single‑use bioreactors, centrifugation, and depth filtration
• Proven experience in process optimization, scale‑up/down activities, technology transfer, and industrialization of biotechnological products
• Solid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines
• Experience supporting regulatory submissions and managing manufacturing processes in FDA‑ and EMA/AIFA‑approved facilities
• Demonstrated ability to manage CDMO partnerships and external development activities
• Strong understanding of product lifecycle management and commercialization strategies for biologics
• Good knowledge of English (written and spoken)