External Manufacturing Manager to Sobi
Poolia Stockholm AB / Kemiingenjörsjobb / Stockholm
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hela Sverige Sobi is looking to recruit an External Manufacturing Manager to our organization responsible for ensuring the steady supply of our products to patients. As an 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 (DP) and Finished Goods (FG) 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 is responsible for managing the CMO network globally to ensure uninterrupted, reliable and sustainable supply of our products. As an external manufacturing manager, you will be subject matter expert (SME) for DP and FG manufacturing and responsible and main contact person for DP and FG CMO 's.
Main responsibilities include:
• Coordinate and drive cGMP manufacturing and supply of DP and FG 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.
• Write and review applicable internal and external SOP 's, manufacturing instructions, sections of annual product quality reviews (APR/PQR), applicable sections in registration files and variations. Review and supervise set up, execution and documentation of technical studies, qualifications and validations. Contribute during set up of new analytical specifications and stability programs and review changes thereof.
• On occasions, you will be involved in sourcing, tech transfers, scale up and validation of DP and FG processes as wells as developing supply and quality agreements.
Qualifications
The right candidate fulfills the following qualifications:
• University degree in Chemistry/Biotechnology and a minimum of 5 years of experience in pharmaceutical or biotech industry with experience coupled to Drug Product manufacturing.
• in-depth knowledge of cGMP manufacturing of pharmaceuticals, preferably 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
Publiceringsdatum2018-05-28ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-06-24
Ange följande referens när du ansöker: 50420
Klicka på denna länk för att göra din ansökanFöretagPoolia Stockholm AB
AdressPoolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm
KontorsadressKungsgatan 57 A
Jobbnummer 4169456
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