Lead Analytical Scientist - Peptide Late-Stage Development

Zealand Pharma; Søborg; On-site; DKK 900,000 - 1,500,000; Full time

Job summary

Zealand Pharma A/S in Denmark seeks a Lead Analytical Specialist to steer late-stage analytical development and provide scientific direction across development and lifecycle projects. You will coordinate with CDMOs and external partners while driving validation and regulatory support for CMC activities.

The role requires strong leadership, mentoring abilities, and extensive GMP/regulatory experience in peptide-centric analytics, shaping strategies across Drug Substance and Drug Product

Qualifications

• M.Sc/PhD within chemistry, biochemistry, pharmaceutical sciences, or another relevant field.
• Extensive experience in the Pharmaceutical Industry within analytical science or QC, including leadership or mentoring.
• GMP and regulatory aspects of late-stage analytical CMC development.
• Experience outsourcing to CMO and CRO
• Familiarity with late-stage analytical development (peptide-based products), validation and LCM support
• Experience leading cross-functional project teams and stakeholder management

Responsibilities

• Lead and take responsibility for analytical late-stage development and support activities in Development and Life Cycle Management projects
• Provide scientific and technical leadership, mentoring colleagues and guiding best practice across the team
• Support Drug Substance and Drug Product development with analytical knowledge and activities such as stability programs, specifications, extractable/leachable studies, in-use characterizations, etc.
• Lead the collaboration with CDMO — following up on oversight plans and day-to-day communication, securing transfer and validation of methods, and supporting technical and QC activities
• Write scientific reports and documentation meeting requirements for pharmaceutical products
• Ensure scientific input to regulatory documents (NDA/MAA) in collaboration with ZP colleagues and CDMO

Skills

Analytical leadership

Project management

Mentoring

Stakeholder management

Cross-functional collaboration

Education

M.Sc/PhD in chemistry/biochemistry/pharmaceutical sciences

Job description

Zealand Pharma A/S in Denmark seeks a Lead Analytical Specialist to steer late-stage analytical development and provide scientific direction across development and lifecycle projects. You will coordinate with CDMOs and external partners while driving validation and regulatory support for CMC activities.

The role requires strong leadership, mentoring abilities, and extensive GMP/regulatory experience in peptide-centric analytics, shaping strategies across Drug Substance and Drug Product