Overview
In this Technical Lead role, you will drive technical excellence and regulatory compliance for DS Biologics manufacturing within SAT. You will lead cross-functional MSAT efforts, lifecycle management, and external supply initiatives to enable reliable, scalable production for clinical and commercial products. You’ll explore new technologies and process improvements to reduce cost and improve yield, while maintaining GMP standards. This is a hands-on, impact-focused opportunity at a global rare-disease specialist. Join a collaborative, growth-oriented team delivering life-saving therapies.
Leistungen / Benefits
- work/life balance
- collaborative and team-oriented environment
- opportunities for professional growth
- diversity and inclusion
- competitive compensation
- positive impact on ultra-rare disease patients
Verantwortungsbereiche
- Subject matter expert for DS Biologics manufacturing
- Process owner of DS Biologics validation for products
- Lead MSAT projects for process and cost improvement (LCM)
- Participate in and lead internal/external manufacturing activities (changes, deviations, risk assessments, CAPAs)
- Write/review SOPs, manufacturing instructions, APR/PQR sections and registrations
- Support supplier evaluation and supply/quality agreements with contract manufacturers
- Manage product transfer, scale-up, validations, and external manufacturing oversight
- Identify and introduce new technologies for process innovation and cost/yield improvements
- Represent SAT in product governance and project portfolio coordination
- Support continuous improvement of internal processes, systems, and templates
Zentrale Anforderungen
- +10 years in manufacturing DS Biologics for commercial use
- Degree in Biology, Biotechnology, Pharmacy or similar (university education)
- Strong Upstream Manufacturing background (cell banking, mammalian cell culture; bacterial fermentation a plus)
- Experience with regulatory guidelines and authorities' communication
- Cross-functional teamwork, multitasking, decision-making ability
- Ability to thrive in unstructured environments and influence without authority
- Fluent in English, good oral/written communication
- Willingness to travel up to 30% of the time
- Experience in process development for clinical/ commercial use is a plus
- strong communication skills
- cross-functional collaboration
- initiative and self-direction
- Upstream manufacturing (mammalian cell culture, cell banking)
- Process validation and qualification
- MSAT and lifecycle management
MSAT Technical Lead - Drug Substance - Biologics in Basel Arbeitgeber: Swedish Orphan Biovitrum
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und internationalen Umfeld zu arbeiten, das sich auf den Zugang zu spezialisierten Gesundheitsprodukten konzentriert. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und zum Networking mit verschiedenen Stakeholdern bieten. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einer positiven Work-Life-Balance, die es Ihnen ermöglichen, Ihre Karriere und Ihr persönliches Leben in Einklang zu bringen.
