Lead Analytical Scientist

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

Does it excite you to lead late-stage analytical development for innovative peptide-based medicines, and do you have a strong technical background in analytical science? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position

As Lead Analytical Specialist, you will lead late-stage analytical development and provide scientific and technical direction across a broad range of activities in Development and Life Cycle Management projects. Given our collaboration with Contract Development and Manufacturing Organizations (CDMO), effective coordination with external partners is a significant aspect of this role.

We Offer Exciting 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

Your profile

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

Your new team

You will be joining a highly experienced team of experts within CMC Development, acting as a technical point of reference and mentor for colleagues. We value a collaborative and supportive atmosphere where we achieve great results together.

Let's bond and be bold

We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

For further information, please contact Director, Head of Drug Substance & Analysis, Iben Almar Meier; [e-mail].

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.