CMC Analytical Project Lead for CDMO Partnerships

Bioarctic; Stockholms kommun; On-site; SEK 900,000 - 1,300,000; Full time

Job summary

BioArctic AB in Stockholm, Sweden, is seeking a CMC Analytical Project Manager to drive analytical development strategies across all project stages in collaboration with external partners. You will plan and coordinate CMC-related analytics with internal teams and CDMOs, ensuring alignment with regulatory expectations.

You bring a master's degree in chemistry or related field, 10+ years in pharma/biotech, and strong leadership with CDMO management and cGMP oversight.

Qualifications

• Master's degree in chemistry, chemical engineering, life sciences, or related field.
• At least ten years of relevant experience in the pharmaceutical or biotechnology industry.
• Expertise in biopharmaceutical process development, analytical development and manufacturing.
• Extensive experience managing CDMO relationships, including cGMP oversight and technical investigations.
• Proven strong leadership and project management skills.
• The ability to communicate in English; Swedish is an advantage.
• Experience working with antibodies is an advantage.

Responsibilities

• Developing and driving the analytical strategy throughout all project phases.
• Working on analytical method qualification and validation, method transfers and troubleshooting.
• Contributing to product specifications, product characterization, comparability studies and assessment of CQAs.
• Monitoring and analyzing trends in stability data.
• Ensuring that analytical methods are relevant and that activities comply with cGMP.
• Managing changes, deviations and risks.
• Writing and reviewing CMC documentation for development studies, manufacturing campaigns, stability studies and regulatory submissions.
• Supporting the identification of CDMOs and reviewing quotations and agreements.

Job description

BioArctic AB in Stockholm, Sweden, is seeking a CMC Analytical Project Manager to drive analytical development strategies across all project stages in collaboration with external partners. You will plan and coordinate CMC-related analytics with internal teams and CDMOs, ensuring alignment with regulatory expectations.

You bring a master's degree in chemistry or related field, 10+ years in pharma/biotech, and strong leadership with CDMO management and cGMP oversight.