Senior MSAT Process Manager Small Molecules

Job DescriptionAs Senior Process Manager MSAT, you will play a key role in ensuring the compliant, robust and sustainable manufacturing of Sobi’s clinical and commercial products. You will be part of the Science and Technology (SAT) Small Molecules team within the Global CMC, Science & Technology Department (GCSAT), where your expertise will help shape, optimize and maintain manufacturing processes across Sobi’s internal and external network. This position is based at our Global Headquarters in Stockholm, Sweden, or our global hub in Basel, Switzerland, and reports to the Group Head Small Molecules. This position is a temporary contract until end of 2026 and with the potential to extend into a permanent position later this year. Key Responsibilities Act as a subject matter expert (SME) for drug product (DP) manufacturing and validation activities. Lead and deliver MSAT projects focused on process optimization, robustness and cost improvements throughout the product lifecycle. Support internal and external manufacturing activities, including process changes, major deviations, risk assessments and CAPA initiatives. Review, approve and contribute to internal and external SOPs and manufacturing instructions. Plan, oversee and document technical studies, qualifications and validation activities. Contribute to the development and review of product specifications and stability programs. Prepare and review relevant sections of APR/PQRs, regulatory filings, variations and market expansion documentation. Support the evaluation and onboarding of new drug product contract manufacturing organizations (CMOs), including the development of quality and supply agreements. Lead technical aspects of product transfers, scale-up activities and validations, and provide technical oversight of external manufacturing for clinical and commercial supply. QualificationsYou are a proactive and collaborative professional who enjoys working in a fast-paced, cross-functional environment. You are motivated by the opportunity to make a real difference for patients with rare diseases and are passionate about continuously improving manufacturing processes. You bring curiosity, accountability and a strong sense of ownership to your work, and you are keen to contribute to a culture of quality, innovation and continuous improvement. Key Qualifications University degree in Chemistry, Biology, Biotechnology, Pharmacy or a related discipline. Minimum 5 years of experience in drug product development and manufacturing for clinical and commercial supply. Strong scientific and technical background in CMC development and small molecules non sterile drug product manufacturing. Proven experience working in cross-functional, international environments, with strong organizational and decision-making skills. Good knowledge of relevant regulatory guidelines, experience interacting with health authorities and preparing regulatory documentation. Fluency in English with strong written and verbal communication skills. Additional InformationHow 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.