Senior Manager

Senior CMC Manager / Specialist - Oslo, NO or Lyngby, DK About Us Nykode Therapeutics is an Oslo-based clinical-stage biopharmaceutical company founded in 2006. Our aim is to generate game-changing therapeutics to treat cancers and autoimmune diseases with a high unmet medical need. Our unique and innovative modular immunotherapy technology delivers antigens directly to antigen-presenting cells (APCs), which is essential for inducing rapid, strong and long-lasting immune responses. Our pipeline spans oncology and autoimmune disease, with DNA- and protein-based programs from discovery through Phase 2 clinical development. This includes off-the-shelf and individualized cancer therapies as well as an immune tolerance platform for autoimmune disease, and our lead program is now being prepared for Phase 3. To support Phase 3 preparation, we wish to strengthen our CMC team with a Senior CMC Manager / Specialist with analytical background. Role Overview As Senior CMC Manager / Specialist, you will take end-to-end ownership of analytical and characterization activities across Nykode’s pipeline, spanning multiple modalities including plasmid DNA (pDNA) and proteins. You will be the primary analytical point of contact for internal teams, contract manufacturing organizations (CMOs), and contract research organizations (CROs), ensuring that analytical strategies, control programs, and quality systems are fit for purpose across all stages of development. Regulatory and late-phase experience is central to this role: you will drive CMC regulatory strategies for analytical and control topics and represent Nykode directly in health authority interactions, from early-phase work through Phase 3 and marketing submissions. The position can be based at our headquarters in Oslo, Norway, or at our office in Lyngby (Copenhagen), Denmark. If based in Denmark, regular travel to Oslo should be expected. Key Responsibilities Analytical Development and Characterization

• Build phase-appropriate analytical packages that take programs from early development through Phase 3 readiness.
• Define and drive characterization strategies that build a thorough understanding of each product, covering identity, purity, integrity, potency, and product- and process-related impurities.
• As a senior member of the multidisciplinary project teams, you will ensure that the projects receive and have the appropriate CMC focus allowing for efficient development while fulfilling regulatory requirements
• Lead and support analytical method development, optimization, and qualification/validation for pDNA and protein products, including compatibility with delivery device.
• Guide and oversee in-house analytical work supporting process development, characterization, and comparability studies, making sure results are critically evaluated and turned into clear decisions.
• Provide scientific expertise across a broad analytical toolbox, including chromatographic (HPLC, SEC, IEX), electrophoretic (CGE, CE-SDS, cIEF), spectroscopic (SoloVPE), mass spectrometric and molecular (qPCR, sequencing) methods, and assess new technologies as programs mature.

CMO & CRO Oversight

• Act as the primary analytical contact for outsourced DS and DP manufacturing, testing, release, and stability programs at CMOs and CROs.
• Define analytical test programs in collaboration with external partners, covering in-process controls, release testing, characterization, and product stability.
• Review and approve analytical data packages from CMOs; manage out-of-specification results, deviations, changes, and CAPAs.
• Support vendor qualification and oversight visits as required.

Specifications & Quality

• Define, justify, and maintain product specifications for drug substance and drug product.
• Perform QC review and approval of analytical data, certificates of analysis, and batch documentation.
• Conduct trending and statistical evaluation of analytical results to support product quality and process understanding.
• Establish and oversee stability programs for drug substance and drug product, ensuring stability-indicating methods and study designs are in place to support shelf-life claims and regulatory submissions.

CMC Regulatory Strategy & Submissions

• Drive the development and execution of CMC regulatory strategy for analytical and control topics across the pipeline, with particular focus on late-stage programs.
• Author, review, and compile CMC analytical sections of regulatory submissions (IND, CTA, IMPD, BLA, MAA), ensuring regulatory compliance.
• Serve as the CMC point of contact for health authority interactions on analytical and control strategy topics, including responses to information requests, briefing documents, and pre-submission meetings.
• Monitor evolving regulatory guidance and ensure CMC analytical strategy and documentation remain aligned with current requirements.
• Collaborate with external regulatory affairs consultants and CDMOs/CROs to support late-stage development and marketing application submissions.

Qualifications and Experience

• MSc or PhD in chemistry, biochemistry, biotechnology, or a related scientific discipline.
• Minimum of 10 years documented track record of industry experience within analytical development / characterization and CMC for biopharmaceuticals.
• Solid understanding of GMP and phase-appropriate analytical control strategies across the development lifecycle.
• Substantial late-phase CMC experience, supporting programs through Phase 3 toward marketing applications
• Demonstrated regulatory experience, including authoring and reviewing CMC analytical sections of IND, CTA, IMPD, BLA, or MAA submissions and contributing to responses to health authority questions.
• Experience working in an outsourced model with CMOs or CROs.
• Ability to support and oversee in-house analytical work as needed alongside strategic and oversight responsibilities.

Personal Traits We are looking for a versatile and proactive professional who is motivated by working with a diverse and evolving pipeline. You take ownership, prioritize well across competing tasks, and keep activities moving forward with limited supervision. You are comfortable making decisions and giving clear direction, and you enjoy supporting and developing colleagues. Strong interpersonal and communication skills are important, as the role involves close collaboration across functions and with external partners and vendors. The Application Process We review applications, CV & Cover letter, on an ongoing basis and encourage interested candidates to apply as soon as possible. The final application deadline is 1 November 2026.