Senior Protein Biologics CMC Leader - Remote Europe

Chiesi Farmaceutici S.p.A.; Parma; Ibrido; EUR 62.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Remote work options

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced senior CMC leader for protein biologics drug substance development within GRD CMC.

You will lead upstream/downstream development, analytical control strategies, comparability, and lifecycle management for recombinant protein therapeutics. The role requires deep CMC expertise, leadership of extended technical teams, and strong English communication.

Competenze

• University degree in biotechnology, biochemistry, biochemical engineering, cell biology, molecular biology, pharmacy, or related discipline; advanced degree is an advantage.
• Significant industrial experience in biologics CMC development with deep expertise in recombinant protein drug substance development, protein expression, and manufacturing.
• Strong understanding of upstream and downstream processing, protein characterization, analytical control strategies, GMP, regulatory expectations, comparability, validation, lifecycle management.
• Experience working with CDMOs, CROs, academic partners, external consultants, and outsourced development or manufacturing models.
• Proven ability to lead extended technical teams, coordinate cross-functional activities, influence stakeholders, and translate complex technical data into clear recommendations, risk assessments, and decision points.
• Excellent written and verbal communication skills in English.

Mansioni

• Act as senior SME for protein biologics DS development with focus on expression, process performance, manufacturability, and product quality.
• Lead or contribute to CMC strategies from candidate selection through clinical supply, tech transfer, characterization, validation, regulatory submission, launch, and lifecycle management.
• Provide guidance on expression systems, cell line development, clone selection, cell banks, media and feed development, upstream/downstream processing, purification, impurity clearance, scale-up, and process control.
• Translate understanding of protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and practical development decisions.
• Lead identification and management of critical quality attributes and product quality attributes including potency, purity, identity, glycosylation, charge variants, aggregation, and stability.
• Drive phase-appropriate control strategies covering process parameters, in-process controls, release testing, comparability, specifications, and lifecycle knowledge management.
• Lead scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, external consultants, ensuring alignment on development plans, deliverables, risks, budget, and timelines.
• Support selection, evaluation, and oversight of external development/manufacturing partners by assessing capability, fit, readiness, analytical capability, facility fit, and risks.
• Contribute to technical and regulatory documentation and GRD CMC ways of working for protein biologics.

Conoscenze

Protein expression

CMC Leadership

Regulatory strategy

Cross-functional leadership

Formazione

Biotechnology degree

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Parma, IT, seeks an experienced senior CMC leader for protein biologics drug substance development within GRD CMC.

You will lead upstream/downstream development, analytical control strategies, comparability, and lifecycle management for recombinant protein therapeutics. The role requires deep CMC expertise, leadership of extended technical teams, and strong English communication.