CMC Analytical Project Manager

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

Would you like to drive the analytical development of biopharmaceuticals in close collaboration with external partners? We are looking for a CMC Analytical Project Manager who wants to combine scientific and technical expertise with project management and coordination across the different stages of drug development.

About the role

You will drive and implement analytical development strategies for projects together with external partners. You will plan and coordinate CMC-related analytical activities, working internally with project teams and other relevant functions and externally with contract development and manufacturing organizations (CDMOs) and other suppliers. You will also work closely with the CMC Project Manager responsible for process activities.

Your main 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 critical quality attributes (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.

Your background

• A master's degree in chemistry, chemical engineering, life sciences or a related field, or an equivalent qualification.
• 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.

Who are you?

You take initiative and responsibility for moving work forward. Drawing on your specialist expertise and analytical skills, you understand complex issues and make well-founded judgments. You remain composed and persistent when problems arise and contribute to stable, trusting working relationships. You communicate clearly and in a structured way, share your knowledge and collaborate to achieve common goals. You thrive in a fast-paced environment and are skilled at prioritizing and coordinating activities to meet project timelines.

Application

22 November 2026

Occupational psychology assessments and a background check will form part of this recruitment process.

Read more about BioArctic at www.bioarctic.com

This recruitment process is managed directly by BioArctic. We kindly decline contact from external recruitment agencies and vendors.

Important: BioArctic never charges candidates any fees during the recruitment process. We will never ask you to pay for interviews, background checks, training, equipment or visa processing. All communication regarding this position will take place through BioArctic's official channels. If you are unsure whether a contact is legitimate, please contact us using the details provided on BioArctic's website.