Senior MSAT Process Manager Small Molecules

Senior MSAT Process Manager Small Molecules

Sobi

Basel, Switzerland

Job Description

As 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.

Qualifications

You 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.