Contract Manufacturing Manager, Drug Substance, to Sobi
Poolia Stockholm AB / Biologjobb / Stockholm
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hela Sverige Sobi is looking to recruit a Contract Manufacturing Manager to our organization responsible for ensuring the steady supply of our products to patients. As a Contract Manufacturing Manager, you will be responsible for managing third-party contract manufacturing organizations (CMOs) and apply your expertise in the areas of Drug Substance 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!
Job description
External Manufacturing at Sobi is the department responsible for managing the CMO network globally to ensure uninterrupted, reliable and sustainable supply of our products. As a contract manufacturing manager, you will be responsible and main contact person for Drug Substance CMO 's and subject matter expert (SME) for up and downstream drug substance manufacturing processes.
Main responsibilities include:
• Coordinate and drive cGMP manufacturing and uninterrupted supply of drug substance 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 SME for drug substance processes and activities at external manufactures. This includes writing and/or reviewing manufacturing instructions, annual product quality reviews (APR/PQR), applicable sections in registration files and variations, internal and external SOP 's, qualifications and validations.
• Be responsible for the business relationship with external drug substance 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.
• On occasions you will be involved in sourcing, tech transfers, scale up and validation of drug substance processes as wells as developing supply and quality agreements.
Qualifications
The right candidate fulfills the following qualifications:
• University degree in Biotechnology and a minimum of 5 years of experience in the biotech industry with experience coupled to drug substance manufacturing, both up and downstream processing.
• In-depth knowledge of cGMP manufacturing of biologics and industry regulatory standards.
• Previous work involving direct contact with CMO 's is a strong merit.
• Excellent verbal and written communication skills in English and ability to communicate in a business environment.
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.
About Sobi
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 2017 Sobi had total revenues of SEK 6.5 billion and about 780 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at
www.sobi.com.Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-10-09ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-11-11
Ange följande referens när du ansöker: 51570
Klicka på denna länk för att göra din ansökanFöretagPoolia Stockholm AB
AdressPoolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm
KontorsadressKungsgatan 57 A
Jobbnummer 4392179
Observera att sista ansökningsdag har passerat.