Lead, Analytical Development – Synthetics

Hemab Therapeutics; København; On-site; DKK 1,100,000 - 1,600,000; Full time

Job summary

Hemab Therapeutics, a clinical-stage biotech, is seeking a Principal Scientist, Analytical Development to lead analytical strategies for synthetic therapeutics including peptides and oligonucleotides. You will drive phase-appropriate method development, set specifications, and lead regulatory submissions from early development through commercial readiness.

You will oversee CROs/CDMOs, collaborate with Drug Substance/Drug Product teams, and contribute to NDAs/MAAs.

Qualifications

• Proven industry experience setting analytical strategy for synthetic therapeutics (peptides & oligonucleotides).
• Strong knowledge of phase-appropriate analytical method development and validations, specs, characterization, and regulatory submissions (NDAs/MAAs).
• Significant experience managing CROs/CDMOs, including guiding external partners.
• Solid understanding of ICH expectations for stability and method validation, with regulatory-submission experience.
• Ability to operate across multiple time zones in a fast-paced biotech environment.

Responsibilities

• Own analytical strategy for synthetics programs from first-in-human through commercial readiness.
• Establish phase-appropriate analytical approaches and specifications, characterization, stability, and risk assessments.
• Provide technical input to CDMOs on method development and validation for purity and product characterization.
• Manage analytical method transfer, optimization, and validation with external partners for commercial readiness.
• Lead CROs/CDMOs, suppliers, consultants and vendors; monitor regulatory trends and identify efficiency improvements.
• Author and review analytical sections of regulatory submissions (NDAs/MAAs) and represent Hemab in regulatory interactions.

Skills

Analytical strategy

Synthetics analysis

CRO/CDMO management

Regulatory submissions

Education

PhD preferred

Scientific degree

Job description

Hemab Therapeutics, a clinical-stage biotech, is seeking a Principal Scientist, Analytical Development to lead analytical strategies for synthetic therapeutics including peptides and oligonucleotides. You will drive phase-appropriate method development, set specifications, and lead regulatory submissions from early development through commercial readiness.

You will oversee CROs/CDMOs, collaborate with Drug Substance/Drug Product teams, and contribute to NDAs/MAAs.