External Manufacturing Manager, Drug Substance/Drug Product to S
Swedish Orphan Biovitrum AB (publ) / 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 Substance and/or 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.
Key Responsibilities:
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 an External Manufacturing Manager, you will be responsible and main contact person for Drug Substance and/or Drug Product CMO 's and may lead cross functional product teams in the operational, tactical and strategical space.
Main responsibilities include:
• Coordinate and drive cGMP manufacturing and uninterrupted supply of drug substance and/or 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, with support of cross functional product teams.
• Be responsible for the business relationship with external drug substance and/or 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.
• Lead a product team with professionals from e.g. Supply Chain, QA, Manufacturing Support, Manufacturing Science & Technology and Regulatory, ensuring continuous supply to patients by ensuring the right focus of operational activities as well as driving improvements and long-term strategic priorities.
• Contribute to 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.
• 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 or other relevant scientific fields, and a minimum of 5 years of experience in the biotech industry with experience coupled to drug substance (both up and downstream processing) and/or drug product manufacturing
• In-depth knowledge of cGMP manufacturing of biologics and/or small molecule pharmaceuticals 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.
Personal attributes:
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.
Location:
The position will be based in Hornsberg, Stockholm. We will interview candidates continuously and welcome your application today!.
Reporting to:
You are reporting to Minna Lundholm Head of External Manufacturing E2E Supply lead Specialty Care, contact information
minna.lundholm@sobi.com.
For more information:
If you are interested in applying for this position, please submit your CV and cover letter through our home page
www.sobi.se jobba här.
Publiceringsdatum2019-11-11Så ansöker duSista dag att ansöka är 2019-12-11
Klicka på denna länk för att göra din ansökanAdressSwedish Orphan Biovitrum AB (Publ)
Tomtebodavägen 23 A
17165 Solna
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Swedish Orphan Biovitrum AB (Publ) (org.nr 556038-9321)
Tomtebodavägen 23 A (
visa karta)
171 65 SOLNA
Arbetsplats Sobi
Jobbnummer 4951010
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