Job Description

External DS/DP Manufacturing is part of External Manufacturing Operations & SRM. External Manufacturing Operations & SRM is responsible for operational oversight of clinical-and commercial- external manufacturing of Drug Substance, Drug Product and Finished Goods (Including IMP Supply) for Sobi projects and products world-wide.

The responsibility includes providing leadership and operational excellence of compliant manufacturing and overseeing the management and delivery from external CMOs and CLOs, that can meet global health authority requirements and Sobi needs today and in the future.

Key Responsibitilies

• Team leader cross functional Virtual Plant Team (DS, DP, CLO as applicable)
• Strategic and operational CMO management:
• Responsible and main contact person for CMOs, leading Business Review and Operational Meetings or provide CMO Management input to partner BRM/JMSC.
• Supplier relationship management for CMO(s), ensuring e.g. supply agreements, change orders, improvements and OTIF delivery
• Participate in Sourcing evaluation of new contract manufacturers and developing supply and quality agreements
• Lead or participate in internal activities related to external manufacturing such as change management, major/critical deviations and CAPAs
• Participate in tech transfer, scale up, validation and manufacturing of DS and DP processes at external manufacturers for Sobi projects in clinical and commercial phase
• Issue, review and/or approve applicable external and internal SOP’s
• Review applicable sections of the APR/PQR
• Budget input and adherence for CMO/CLO related costs
• Lead or participate in projects
• Driving continuous improvements in order to maintain efficient ways of working internally and at external network.

Qualifications

Education/Learning Experience/Work Experience

Required: __

• University degree in Biotechnology or other relevant scientific fields, or equivalent work experience
• 5 years of experience in the pharmaceutical industry coupled to drug substance (both up and downstream processing) and/or drug product manufacturing
• Min 2 years’ experience from coordinating roles, including Project Management
• Good knowledge of cGMP manufacturing of biologics and/or small molecule pharmaceuticals, including investigating deviations and change management.
• Previous work experience involving direct contact with CMO´s/CLO’s or other external parties
• Good knowledge of Office and hands on experience of digital systems
• Ability to work in a cross functional matrixed environment and to successfully collaborate with internal and external parties

Skills/Knowledge/Languages

Required: Excellent verbal and written communication skills in English and ability to communicate in a business environment

Personal Attributes

Required:

• Driven, flexible, collaborative, and have strong team working skills
• Analytical and have a problem solving mindset.
• Strong ability to work independently and to make priorities in order to deliver business critical items in time.
• Demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.

Desired:

• Negotiation skills

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.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to florencia.mendez@sobi.com.