MSAT Technical Lead

Manufacturing Science and Technology  (MSAT) is part of the Global CMC Science & Technology Department (GCSAT).

GCSAT is responsible for optimization and life cycle management of Sobis clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant reliable cost effective and sustainable manufacturing of our products now and in future. The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobis clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.

Main responsibilities:

• Process owner of DS validation for Sobi products.
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of 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 SOPs 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 DS contract manufacturers and participation in developing supply and quality agreements.
• Lead the technical part of a product transfer scale up activities validations and oversees manufacturing of DS processes at external manufacturers for Sobi projects in clinical and commercial phase.
• Be aware of external biopharmaceutical manufacturing technology advancements understand and introduce new technologies and how they may be applicable to process innovation cost or yield improvement

Qualifications :

• University education in Chemistry Biology Biotechnology Pharmacy or similar.
• 5 years of experience of development and manufacturing of Drug Substance for clinical and commercial use
• Scientific and technical background of CMC development and manufacturing of Drug Substance.
• Recognized expert in drug substance manufacturing
• Demonstrable experience of working in cross functional team with ability to multi task prioritize and be an effective decision maker
• Experience of regulatory guidelines regulatory authorities communication and file documentation
• Fluent in English

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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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.

Remote Work :

No

Employment Type :

Full-time