About us

Hansa Biopharma is a fast-growing, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with acute or complex immune disorders.

Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.

By empowering our people we move our projects forward with high speed, efficiency and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.

Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.

Position summary 

We are seeking an experienced and dynamic Senior CMC Project Lead to join our growing CMC development organization. This is a critical leadership role that bridges technical, strategic, and operational functions to drive the Chemistry, Manufacturing and Controls (CMC) strategy for our biologics programs.

This is a permanent, full-time position based in Lund, Sweden. The role reports to the Head of Early stage CMC development and Manufacturing.

The successful candidate will oversee end-to-end CMC activities - from process development and analytical characterization and technology transfer - ensuring seamless execution of development milestones and regulatory submissions.

Key tasks and responsibilities

• Lead and coordinate CMC project execution for biologics programs, from early development through clinical and commercial stages.
• Serve as the primary CMC representative on cross-functional project teams, providing expert input on DS and DP manufacturing, analytics, and regulatory strategy.
• Oversee process development and scale-up activities for upstream and downstream biologics processes, ensuring robust, scalable, and regulatory-compliant solutions.
• Drive analytical development, method qualification/validation, and product characterization activities in alignment with regulatory expectations.
• Lead technology transfer initiatives to ensure smooth and timely handover of processes and analytical methods.
• Manage timelines, budgets, and resources for CMC workstreams, proactively identifying and mitigating risks.
• Contribute to regulatory submissions (e.g., IND, IMPD, BLA/MAA) by authoring or reviewing CMC sections and participating in agency interactions.

Education and experience requirements

• Advanced degree (PhD, MSc, or equivalent) in Biochemistry, Biotechnology, Chemical Engineering, or related discipline.
• 8+ years of industry experience in biologics development with strong expertise in at least two of the following areas:

• Process development (upstream/downstream)
• Analytical development and characterization
• GMP manufacturing (clinical or commercial scale)
• Technology transfer to internal or external manufacturing sites

• Proven track record of leading CMC activities for biologics through multiple development stages.

• Strong understanding of regulatory requirements and expectations for biologics development and commercialization.

• Excellent communication, organizational, and leadership skills, with the ability to influence across functions and levels.

• Experience working in a matrixed, global environment and managing external partners (e.g., CDMOs, CROs) is highly desirable.

About you

As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

• A collaborative mindset with strong communication and interpersonal skills – you enjoy working with others to achieve common goals.
• A structured and proactive approach – you plan ahead, take initiative, and drive progress efficiently.
• A strategic yet hands-on attitude – you can see the bigger picture while also being comfortable managing details when needed.
• A sense of accountability and integrity – you take ownership of your work and deliver on commitments.

Our culture and values

Working at Hansa is more than a job for us, and our culture is characterised by pride — pride in what we do, in our company, and in what we have achieved and will accomplish for patients around the world.

Our culture is built on our core values: Accountability, Courage, Integrity, and Pioneering. These values guide how we work, collaborate, and make decisions every day.

We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve.

Reasons to join the Hansa Team

• Opportunity to shape and lead CMC strategy for innovative biologics programs.
• Collaborative and science-driven culture that values innovation, impact, and continuous learning.
• Work at the cutting edge of biologics development, contributing to life-changing therapies.
• A position in a company that envisions life changing outcomes for patients with acute or serious immune mediated conditions.
• The chance to be part of an innovative R&D-driven organisation with a strong desire to make a difference for people.
• An opportunity to build a fully integrated biopharmaceutical company with global outreach.
• An open-minded and welcoming atmosphere. Friendly, motivated and skilled colleagues with whom you can both laugh and work.

Type of employment and location

This is a permanent, full-time (40-hours) position based in Lund, Sweden. The role requires regular on-site presence, with an expectation of four days per week in the office.

Start date as soon as possible. 

The process

Please apply for the position through the following link. Applications should not be sent through any other platform.

Attach your CV and a cover letter in English only. Unfortunately, we are unable to review applications made in other languages.

The process is ongoing and we will review applications as they are received.

For questions regarding the position and process, please contact the recruiting manager: Amelia Hofgren, Head of Early stage CMC development and Manufacturing.

We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research!

Please note: No external recruitment support is required. Only applications received directly will be considered.