MSAT Technical Lead - DP at Sobi

Stockholm, , Sweden -

Full Time

Start Date

Immediate

Expiry Date

14 Sep, 26

Salary

0.0

Posted On

16 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Drug Product Manufacturing, Aseptic Processing, CMC Development, Process Validation, Lifecycle Management, CAPA, Risk Assessment, Regulatory Documentation, Product Transfer, Scale-up Activities, SOP Development, Technical Study Execution

Industry

Pharmaceutical Manufacturing

Description

Company Description At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo. We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development. Job Description About the role As MSAT Technical Lead, you will play a pivotal role in ensuring the compliant, reliable, and sustainable manufacturing of Sobi’s clinical and commercial products. You will be part of the Manufacturing Science and Technology (MSAT) team within the Global CMC, Science & Technology Department (GCSAT), contributing your expertise to optimize and manage manufacturing processes across Sobi’s internal and external networks. This position is based at our Global Headquarters in Stockholm, Sweden or Global hub in Basel, Switzerland, reporting directly to Group Head Aseptics DP. Key Responsibilities Serve as the subject matter expert (SME) for drug product (DP) manufacturing and validation. Lead and execute MSAT projects focused on process and cost improvements as part of lifecycle management. Participate in activities related to internal and external manufacturing, including process changes, major deviations, risk assessments, and CAPAs. Issue, review, and approve internal and external SOPs and manufacturing instructions. Oversee the setup, execution, and documentation of technical studies, qualifications, and validations. Contribute to the development and review of new product specifications and stability programs. Write and review relevant sections of APR/PQR, registration files, variations, and market expansion documents. Support the evaluation and onboarding of new DP contract manufacturers, including developing supply and quality agreements. Lead technical aspects of product transfers, scale-up activities, validations, and oversee manufacturing at external partners for clinical and commercial projects. Stay informed about advancements in biopharmaceutical manufacturing technology and introduce innovations that drive process improvement, cost reduction, or yield enhancement. Qualifications About you You are a driven and collaborative professional with a passion for advancing biopharmaceutical manufacturing. You thrive in dynamic, cross-functional environments and are motivated by the opportunity to make a meaningful impact for patients with rare diseases. You are committed to continuous learning, embrace new technologies, and are eager to contribute to a culture of innovation and excellence. Your strong communication skills, ability to act independently, and dedication to Sobi’s core values—Care, Ambition, Urgency, Ownership, and Partnership—set you apart. Key Qualifications University degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related field. At least 5 years of experience in the development and manufacturing of drug products (DP) for clinical and commercial use. Deep scientific and technical expertise in CMC development and aseptic drug product manufacturing. Recognized as an expert in aseptic drug product manufacturing. Demonstrated experience working in cross-functional teams, with the ability to multitask, prioritize, and make effective decisions. Strong knowledge of regulatory guidelines, experience in communication with regulatory authorities, and proficiency in preparing regulatory documentation. Fluent in English, with excellent oral and written communication skills. Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership! Additional Information How to apply We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English. Why Join Us? Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: Emphasis on work/life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation for your work Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. Sobi Location: Sweden

Responsibilities

Serve as the subject matter expert for drug product manufacturing and validation to ensure compliant and sustainable production. Lead MSAT projects focused on process improvements, technical transfers, and the management of internal and external manufacturing networks.