Upstream Biological Process, Lead Scientist (Parma, IT)

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

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

Global Technical Operations & Supply

Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.

This is what you will do

This role is a senior leadership position responsible for driving the industrialization and lifecycle management of upstream biopharmaceutical processes as individual contributor. It focuses on leading process insourcing, technology transfer, scale‑up, and validation activities to ensure robust, scalable, and compliant manufacturing from development through commercial production.

The position acts as a key interface across R&D, CDMOs, Production, Quality, and Engineering, coordinating process development, optimization, and characterization while applying Quality by Design (QbD) principles and ensuring alignment with global regulatory expectations (FDA, EMA, ICH).

The role requires strong scientific and technical expertise in upstream biologics, combined with hands‑on leadership in pilot and commercial environments. It also involves supporting regulatory submissions, managing process risks and deviations, and enabling continuous improvement and operational excellence.

A critical component is influencing cross‑function teams, translating complex data into strategic decisions, and building robust product know‑how as a competitive advantage. The role contributes directly to organizational transformation by strengthening industrial capabilities and ensuring successful delivery of biologics programs in a dynamic global setting.

You will be responsible for

• Providing hands‑on scientific and technical leadership in process insourcing, technology transfer, scale‑up, and validation activities, ensuring robust, scalable, and compliant biopharmaceutical manufacturing processes.
• 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) and representing CMC process‑related topics during interactions with health authorities.
• 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.
• Providing technical expertise for investigations, process deviations, change controls, and CAPAs, ensuring effective resolution and continuous process improvement.
• Delivering theoretical and practical training to Manufacturing personnel to ensure compliant and efficient execution of commercial production processes.

You will need to have

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline.
• At least 10 years of experience in biopharmaceutical drug substance process development, with a proven track record of 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 (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).

Leadership & Competencies

• Advanced analytical and problem‑solving skills, with the ability to synthesize complex datasets into actionable insights.
• Proven leadership capability, with good communication skills and the ability to influence across all organizational levels.
• Excellent collaboration skills with personnel from different company functions;
• Ability to work on multiple projects while meeting agreed deadlines;
• Ability to work in a dynamic and global environment;
• Willingness to travel if necessary.

Location

Parma

Compensation Range

The minimum salary for this role is € 62.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.