Are you interested in overseeing contract manufacturing operations for drug products?
Sobi is looking to recruit a Manager for Outsourced Manufacturing to our organization responsible for ensuring the steady supply of our products to patients. As a Manager for Outsourced Manufacturing, you will be responsible for managing third-party contract manufacturing organizations (CMOs) and apply your expertise in the areas of cGMP manufacturing of biopharmaceutical drug products and CMO operations. 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 responsible for managing the CMO network globally to ensure uninterrupted, reliable and sustainable supply of products to patients. As a Manager for Outsourced Manufacturing, you will be subject-matter expert for Drug Product (DP) and Finished Goods (FG) manufacturing 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, 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.
- 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.
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 Substance or 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, analytical and flexible. You have a problem-solving mindset, a strong ability to work independently and ability to prioritize 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.