External Manufacturing Manager
Vor 5 Tagen
As the External Manufacturing Manager, you will be part of the External Manufacturing Operations & SRM team, 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 worldwide. Your key responsibilities will include:
Key Responsibilities
- Leading cross-functional Virtual Plant Teams (DS, DP, CLO as applicable).
- Acting as the main contact person for CMOs, leading Business Review and Operational Meetings, or providing CMO Management input to partner BRM/JMSC.
- Managing supplier relationships for CMOs, ensuring supply agreements, change orders, improvements, and OTIF delivery.
- Participating in sourcing evaluations of new contract manufacturers and developing supply and quality agreements.
- Leading or participating in internal activities related to external manufacturing such as change management, major/critical deviations, and CAPAs.
- Driving continuous improvements to maintain efficient ways of working internally and at the external network.
Qualifications
About you:
You are driven, flexible, and collaborative, with strong team-working skills. You possess an analytical mindset and have a strong ability to solve problems. You are capable of working independently and are adept at prioritizing tasks to ensure the timely delivery of business-critical items. You demonstrate the Sobi Values by showing care for our patients, colleagues, and company, and exhibit ambition, urgency, ownership, and partnership in your work. Additionally, you have strong communication skills in English, both verbal and written, which are essential for effectively operating in a business environment.
- University degree in Biotechnology or other relevant scientific fields, or equivalent work experience.
- 5 years of experience in the pharmaceutical industry related to drug substance (both upstream and downstream processing) and/or drug product manufacturing.
- Minimum 2 years’ experience in 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 CMOs/CLOs or other external parties.
- Ability to work in a cross-functional, matrixed environment and successfully collaborate with internal and external parties.
- Excellent verbal and written communication skills in English and the ability to communicate in a business environment.
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.
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