External Manufacturing Manager

Vor 4 Tagen

Basel, Schweiz Sobi Vollzeit

Role & Function

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

Location

The position will be based in Switzerland.

Reporting to

Had of External Drug Substance and Drug Product Manufacturing

**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**

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