Job Description

The right candidate will manage the following tasks :

• Subject matter expert (SME) for Drug Substance of small molecule, non sterile dosage forms.
• Process owner of Drug Substance small molecule, non sterile dosage forms validation for Sobi products.
• 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.
• Contribute during set up of new analytical specifications and stability programs and review changes thereof
• Write and review applicable sections of the APR / PQR.
• Write and review applicable sections in registration files, variations and market expansion
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
• Support in sourcing evaluation of new Drug Substance small molecule, non sterile dosage form 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 Drug Substance small molecule, non sterile dosage forms 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

Education / Learning Experience / Work Experience

Skills / Knowledge / Languages

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values : Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 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, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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 can’t 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.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and / or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.