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Sobi is looking for a consultant to our External Manufacturing Department. External Manufacturing is responsible for ensuring the steady supply of our products to patients. As consultant External Manufacturing Manager, you will be responsible for managing third-party contract manufacturing organizations (CMOs) and apply your expertise in the areas of Drug Product cGMP manufacturing, CMO operations and business management. You will be part of a fun experienced team and have the opportunity to share your knowledge and experiences with dedicated co-workers and external partners. The position is based in Hornsberg, Stockholm. We will interview candidates continuously and welcome your application today!
External Manufacturing is responsible for managing the CMO network globally to ensure uninterrupted, reliable and sustainable supply of our products. As an External Manufacturing Manager Drug Product, you will be subject matter expert (SME) for Drug Product manufacturing processes and responsible and main contact person for Drug Product CMO s. The Products are mainly sterile parenteral drugs e.g. recombinant proteins and mAbs (Biologics).
- Be SME for Drug Product processes and activities at external manufactures. This includes; being technical and scientific lead for Drug Product manufacturing processes during clinical and commercial manufacturing, tech transfers, scale up and validations. Life cycle management of Drug Product processes to keep processes robust and in a compliant state and propose process optimizations.
- Write and/or review manufacturing instructions, annual product quality reviews (APR/PQR), applicable sections in registration files and variations, internal and external SOP s, qualifications and validations.
- Coordinate and drive cGMP manufacturing and uninterrupted supply of drug product at external manufacturers as well as internal activities related to external manufacturing and supply such as, release and delivery, major/critical deviations and CAPAs, process changes and Change control.
- Be business responsible for external drug product manufacturers. This includes being responsible for and coordinating steering committee meetings with CMOs, drive and follow up on KPIs, negotiate and implement amendments and change orders to current supply agreements.
The right candidate fulfills the following qualifications:
-University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 5-10 years of experience in the biotech industry
-Experience and in-depth knowledge of Drug Product development and manufacturing of sterile parenteral drugs/biologics
-Extensive experience of and knowledge of cGMP manufacturing of biologics and industry regulatory standards.
-Excellent verbal and written communication skills in English and ability to communicate in a business environment.
-Previous work involving direct contact with CMO s is a merit.
To be successful in the role you are driven, flexible and thrive in a role that requires both operational management and strategic overview. You are analytical and have a problem solving mindset. You have a strong ability to work independently and to make priorities in order to deliver business critical items in time. Strong team working skills are required to work effectively and establish/maintain effective working relationships with internal/external partners.
The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.
Sobi is an international rare-disease company dedicated to making a significant difference for individuals with rare diseases by providing access to innovative treatments. Our Vision is to be recognized as a global leader in providing access to innovative treatments that make a significant difference for individuals with rare diseases. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2018 Sobi had total revenues of SEK 9.3 billion and about 1000 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com.
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