External Manufacturing Manager

Job content

Role & Function

Ready for a new exciting challenge? At Sobi we have a great opportunity within our External Drug Substance and Drug Product manufacturing group, we are looking for a new member of our team as External Manufacturing Manager to support uninterrupted supply of our rare disease products to our patients around the globe. Within the role you will work closely with several people from different nationalities and backgrounds while building a strong network of colleagues within Sobi and with our external partners (CMOs/CLOs).

Your main goal is to lead these cross-functional teams towards flawless execution and delivery of projects and medicines to the next node in the supply chain. All of this while we hold ourselves to GMP requirements and regulations and our quality standards.

If this sounds interesting please keep reading the job description and apply on the button below!

Key Responsibilities

• 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
• 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 and manufacturing instructions
• Review applicable sections of the APR/PQR
• Budget input and adherence for CMO/CLO related costs
• Lead or participate in projects
  

Qualifications

• 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 MS 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
• Excellent verbal and written communication skills in English and ability to communicate in a business environment
  

Personal attributes:

• Driven, flexible, prestige less, 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.
  

In addition, you must demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.

If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.

Why Join Us?

We are a global company with around 1,500 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.

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