MSAT Technical Lead

MSAT Technical Lead

Sobi

Basel, Switzerland

Job Description

The Technical Lead is pivotal in ensuring technical excellence, regulatory compliance, and the continuous improvement of manufacturing processes. The incumbent will drive cross-functional collaboration to support the launch and lifecycle management of products, technology transfers, and the implementation of innovative methodologies.

Key Responsibilities

• Subject matter expert (SME) for DP Aseptics manufacturing;
• Process owner of DP Aseptics validation for Sobi products;
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of life-cycle management (LCM);
• Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs;
• Issue, review and approve applicable internal and external SOP’s and manufacturing instructions;
• Review and supervise set up, execution and documentation of technical studies, qualifications and validations;
• Write and review applicable sections of the APR/PQR;
• Write and review applicable sections in registration files, variations and market expansion;
• Support in sourcing evaluation of new DP Aseptics contract manufacturers and participation in developing supply and quality agreements;
• Lead the process technical part of a product transfer, scale up activities, validations and oversees manufacturing of DP Aseptics processes at external manufacturers for Sobi projects in clinical and commercial phase;
• Be aware of external pharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement;
• Represent SAT in product governance teams as needed, including potentially coordinating the oversight and escalation of project portfolio;
• Support SAT and Sobi’s continuous improvement program for internal business processes, systems and templates.

Qualifications

Key requirements

• University degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related field;
• +8 years of experience of manufacturing of DP Aseptics for commercial use. Additional experience in clinical manufacturing and process development for clinical and commercial use is a plus;
• Scientific and technical background of CMC development and manufacturing of DP Aseptics;
• Recognized expert in DP Aseptics manufacturing;
• Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker;
• Experience of regulatory guidelines, regulatory authorities’ communication and file documentation;
• Fluent in English;
• Ready to be travelling up to 30% of the time.