Senior Process Manager MS&T

About the role

As Senior Process Manager MSAT you will play a pivotal role in ensuring the compliant reliable and sustainable manufacturing of Sobis clinical and commercial products. You will be part of the Manufacturing Science and Technology (MSAT) team within the Global CMC Science & Technology Department (GCSAT) contributing your expertise to optimize and manage manufacturing processes across Sobis internal and external networks.

This position is based at our Global Headquarters in Stockholm Sweden or Global hub in Basel Switzerland reporting directly to Group Head Aseptics DP.

Key Responsibilities

• Serve as the subject matter expert (SME) for drug product (DP) manufacturing and validation.
• Lead and execute MSAT projects focused on process and cost improvements as part of lifecycle management.
• Participate in activities related to internal and external manufacturing including process changes major deviations risk assessments and CAPAs.
• Issue review and approve internal and external SOPs and manufacturing instructions.
• Oversee the setup execution and documentation of technical studies qualifications and validations.
• Contribute to the development and review of new product specifications and stability programs.
• Write and review relevant sections of APR/PQR registration files variations and market expansion documents.
• Support the evaluation and onboarding of new DP contract manufacturers including developing supply and quality agreements.
• Lead technical aspects of product transfers scale-up activities validations and oversee manufacturing at external partners for clinical and commercial projects.
• Stay informed about advancements in biopharmaceutical manufacturing technology and introduce innovations that drive process improvement cost reduction or yield enhancement.

Qualifications :

About you

You are a driven and collaborative professional with a passion for advancing biopharmaceutical manufacturing. You thrive in dynamic cross-functional environments and are motivated by the opportunity to make a meaningful impact for patients with rare diseases. You are committed to continuous learning embrace new technologies and are eager to contribute to a culture of innovation and excellence. Your strong communication skills ability to act independently and dedication to Sobis core valuesCare Ambition Urgency Ownership and Partnershipset you apart.

Key Qualifications

• University degree in Chemistry Biology Biotechnology Pharmacy or a related field.
• At least 5 years of experience in the development and manufacturing of drug products (DP) for clinical and commercial use.
• Deep scientific and technical expertise in CMC development and aseptic drug product manufacturing.
• Recognized as an expert in aseptic drug product manufacturing.
• Demonstrated experience working in cross-functional teams with the ability to multitask prioritize and make effective decisions.
• Strong knowledge of regulatory guidelines experience in communication with regulatory authorities and proficiency in preparing regulatory documentation.
• Fluent in English with excellent oral and written communication skills.

Here at Sobi we live by our core values: Care Ambition Urgency Ownership and Partnership!

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