MSAT Technical Lead

Science and Technology (SAT) 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 and analytical processes from internal and external network. SAT ensures compliant reliable cost effective and sustainable manufacturing and testing of our products now and in future. The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobis clinical and commercial products and is responsible for always keeping the internal and external manufacturing/analytical processes in a validated stage. 

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 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 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 Sobis 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 
• Recognizedexpert 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. 

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.

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 cant 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.

Remote Work :

No

Employment Type :

Full-time