Commercial Supply Chain Manager

Senior QA Manager Validation & Quality

SallyQ AB

Hansa Biopharma develops innovative treatments that give patients with rare and serious immune-mediated conditions a chance to a better life. We are now looking for an experienced Senior QA Manager Validation and Quality, to help shape our quality work at one of the most exciting biotech companies in the Nordics. About the role You will be a key player in a QA team of six dedicated colleagues, all based at our office in Lund. As Senior QA Manager, you will drive and approve validation activities - spanning process, cleaning and analytical method validation - with a clear quality perspective. You will act as subject matter expert supporting cross-functional teams, external partner management and regulatory authority inspections. This is the right role for you if you thrive with both strategic ownership and operational presence - where one day you are reviewing validation documentation and the next you are in dialogue with a CDMO or preparing a team for an authority inspection. Your responsibilities: Provide strategic and operational direction for quality management and validation across development, clinical and commercial manufacturing QA review and approval of validation documentation Supplier quality management: guide and qualify external manufacturing partners (CDMOs/CMOs) throughout the product lifecycle Support authority inspections and internal/external audits of suppliers and vendors Cross-functional collaboration with CMC, Regulatory, Clinical and Supply Chain Drive continuous improvement of the Quality Management System (QMS) and proactively identify areas for development Who are you? We believe you are a seasoned QA professional with broad experience across both drug substance (DS) and drug product (DP) manufacturing. You are thorough and results-oriented, but also a natural collaborator who knows when to take the lead and when to seek input from others. We are looking for someone with: Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation Proven track record of leading validation activities for DS and DP through clinical and commercial stages Strong knowledge of aseptic manufacturing and biotechnology processes Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation Experience managing external partners and CDMOs/CMOs Experience of authority inspections (FDA, EMA) as presenter and/or coordinator Strong communication skills and the ability to influence across functions and organisational levels What we offer At Hansa, you will not just have a job - you will have a role where your work directly contributes to changing lives for patients with acute and complex immune disorders. A close-knit, welcoming culture in a mid-sized company where you can see how your contribution makes a difference The opportunity to help build a fully integrated biopharmaceutical company with global reach Talented, driven colleagues with an open and entrepreneurial mindset A strong pipeline built on Hansa’s proprietary IgG-cleaving enzyme technology platform Office in Lund, at the heart of a vibrant Life Science ecosystem Our values At Hansa, we are guided by our core values: Accountability, Courage, Integrity and Pioneering. We believe in the power of diversity and are committed to building an inclusive workplace where every perspective is valued. Appealing? 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.

Senior Outsourcing Manager - Camurus (Lund)

TOBLOR Consulting AB

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role you will get the opportunity to work with committed colleagues in a collaborative team. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the way we work with our outsourced manufacturing activities. We are looking for an experienced Senior Outsourcing Manager to join our Manufacturing Operations team. In this role, you will be responsible for driving outsourcing programs for injectable pharmaceutical products to Contract Manufacturing Organizations (CMOs), with a particular focus on late-stage development projects. As Senior Outsourcing Manager, you will serve as the primary interface between Camurus and external manufacturing partners. This is a true Project Management role where you will ensure successful project execution from technology transfer through start of commercial production. You will work closely with internal stakeholders and external partners to secure reliable, compliant, and efficient delivery of the project. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Develop and manage project plans, timelines, and milestones for technology transfer, process development, process validation, and manufacturing readiness activities together with CMO partners. · Drive day-to-day collaboration with CMOs and ensure agreed deliverables, timelines, and performance targets are achieved. · Lead operational meetings and steering committee meetings with external manufacturing partners. · Identify risks and issues proactively and drive mitigation and resolution activities together with internal and external stakeholders. · Coordinate and manage changes with CMOs, ensuring proper documentation, implementation, and alignment with project plans and contractual commitments. · Collaborate closely with internal Camurus functions such as Quality, R&D, Regulatory Affairs and Supply Chain to ensure successful project execution. · Ensure manufacturing activities are conducted in accordance with applicable GMP requirements and regulatory expectations. · Support continuous improvement initiatives related to outsourcing, external manufacturing operations, and CMO performance. Candidate profile We are looking for a professional with extensive experience from pharmaceutical manufacturing operations including outsourcing and CMO management. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have a solid understanding of GMP-regulated manufacturing environments and a proven track record of managing outsourcing programs and external manufacturing partners within the pharmaceutical or biotech industry. Experience from late-stage development, technology transfer and commercial manufacturing is highly valued. Experience from injectable products and combination products is considered a strong merit. As a person, you are structured, collaborative, and communicative, with a proven ability to drive complex projects and build strong relationships across multiple stakeholders. You combine a proactive and results-oriented mindset with a pragmatic and hands-on approach, while maintaining a humble and low-prestige attitude. Fluency in spoken and written and English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!

Senior Process Engineer - Camurus (Lund)

TOBLOR Consulting AB

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role, you will get the opportunity to work with committed colleagues in a collaborative team, close to both commercialised products and development projects. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the outsourced manufacturing processes throughout the product lifecycle. We are looking for an experienced Senior Process Engineer to join our Manufacturing Operations team. In this role, you will be responsible for leading technology transfer activities for manufacturing processes for injectable pharmaceutical products, from development into manufacturing environments at Contract Manufacturing Organizations (CMOs). You will support products from clinical development through to commercial supply. As Senior Process Engineer, you will act as a subject matter expert in pharmaceutical manufacturing processes, working closely with internal stakeholders and external partners to ensure robust, scalable, and GMP-compliant manufacturing operations. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Lead technology transfers of injectable pharmaceutical products from development into commercial manufacturing at CMOs. · Partner with R&D to ensure that formulation and process development activities support successful scale-up, manufacturability, and long-term process robustness. · Provide technical support for process development, scale-up, validation, and commercial manufacturing activities at CMOs. · Act as technical lead for investigations and troubleshooting of process deviations, OOS results, manufacturing failures, and other complex technical challenges. · Contribute to CMC documentation in support of global regulatory submissions and product lifecycle management. · Ensure that manufacturing processes are executed in accordance with applicable GMP requirements and regulatory expectations. Candidate profile We are looking for a professional with at least 7 years of experience from pharmaceutical manufacturing operations. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have hands-on experience from manufacturing process development, technology transfer, and GMP-regulated pharmaceutical manufacturing, preferably within sterile or injectable products. Experience from fill-finish operations and combination products development is considered a strong merit. As a person, you are collaborative, responsible, and driven by solving problems. You enjoy getting to the bottom of complex technical challenges and you are a pragmatic team player who takes ownership and follows through on commitments. At the same time, you are humble and low-prestige, always willing to support colleagues and contribute wherever needed. You thrive in a dynamic environment where technical expertise, collaboration, and problem-solving go hand in hand. Fluency in spoken and written English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!