Hansa Biopharma is seeking an experienced Manufacturing Science & Technology expert with deep hands-on expertise in biologics manufacturing and GMP quality systems. In this role, you will take lead on the CMC processes and play a critical part in ensuring operational excellence.
You will actively shape and strengthen the biologics CMC quality framework, ensuring the quality and regulatory compliance of externally manufactured drug substance and drug product batches. Acting as a go-to expert, you will provide guidance on complex GMP and manufacturing topics related to our innovative protein-based therapies, combining both strategic direction and operational oversight.
As Senior CMC & Quality Manager working within CMC project teams, you will represent an independent quality perspective at the interface with Quality Assurance, supporting robust decision-making across the organization.
You will report to the Head of CMC Early-Stage Development and Manufacturing and work cross-functionally in a science-driven, dynamic organization.
****Main responsibilities:****
- Act as the recognized internal SME for CMC Quality related to biologics and GMP compliance for biological drug substance and drug product manufacturing.
- Strengthen and continuously improve CMC quality systems, promoting a proactive, science-based, and compliance-driven quality culture while identifying process improvement opportunities.
- Coordinate and manage deviation investigations, change controls, CAPAs, and risk assessments.
- Contribute to, and support, interactions with regulatory authorities (e.g., FDA, EMA).
- Review and approve Master Batch Records, protocols, validation documentation, and technical reports.
- Provide robust quality oversight of CDMOs, CMOs, and CROs, including supplier qualification, performance monitoring (KPIs), and continuous improvement initiatives.
- Act as vendor responsible and perform periodic Vendor review
- Contribute to the establishment and maintenance of Quality Agreements.
****Your profile****
You are a quality focused manufacturing expert with strong pharma experience and broad scientific knowledge. You act confidently as SME across drug substance and drug product activities, from early development through commercial supply. You are a stategic thinker, improvement oriented and combine a strong understanding of regulatory framework with a high level of ownership. You thrive in a collaborative, science-focused environment and make risk-based decisions in a structured manner.
****Qualifications:****
- M.Sc(or equivalent) in Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemistry, Engineering, or related life science field.
- Typically, 8+ years of experience in GMP manufacturing of biologics.
- Demonstrated in-depth scientific understanding of biologics manufacturing processes (e.g., recombinant proteins, enzymes, monoclonal antibodies or similar).
- Extensive experience supporting both clinical development and commercial manufacturing.
- Solid hands-on experience working within GMP-regulated quality systems.
- Proven track record in oversight of CDMOs/CMOs in a virtual or outsourced manufacturing structure.
- Experience interacting with global health authorities and supporting regulatory inspections.
- Strong understanding of regulatory expectations for biologics throughout the product lifecycle.
- Excellent communication skills in English.
****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.
For best cultural fit we assume you share 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.
****Why Join****
In this position you will contribute to life changing outcomes for patients with acute or serious immune mediated conditions.
You will be part of an innovative R&D-driven organisation with a strong desire to make a difference for people and also be part in building a fully integrated biopharmaceutical company with global outreach.
You will become part of a mid-sized company with open-minded, motivated colleagues and a truly welcoming atmosphere. At Hansa, we face challenges together and celebrate our achievements as a team.
****Apply?****
Please send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.
****About Hansa****
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.
