Subject Matter Expert Drug Product Manufacturing, Science and Te
Swedish Orphan Biovitrum AB (publ) / Kemistjobb / Stockholm
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hela Sverige Sobi is looking to recruit a Drug Product Subject Matter Expert (SME) to our Manufacturing, Science and Technology (MS&T) department. MS&T is part of the Global Manufacturing Department, which is responsible for strategies and oversight of clinical, commercial, internal and external manufacturing of Drug Substance, Drug Product and Finished Goods for Sobi projects and products world-wide.
MS&T holds the senior scientific and technical knowledge for the manufacturing of our clinical and commercial products and is responsible for keeping our internal and external manufacturing processes in a validated state. MS&T drives the development and life cycle management for our clinical and commercial manufacturing processes from the internal and external network to ensure compliant reliable, cost effective and sustainable manufacturing of our products.
Job Description
As an SME within MS&T your main responsibilities includes:
• Provide technical and scientific expertise within Drug Product manufacturing.
• Act as SME in deviation investigations, CAPA and Change control
• Provide technical and scientific expertise for primary containers and relevant medical devices
• Be up to date in quality requirements for pharmaceutical products
• Technical and scientific expertise for tech transfers of Sobi drug product manufacturing processes
• Technical and scientific expertise for scale up of Sobi Drug Product processes
• Technical and scientific expertise for validations of Sobi Drug Product processes
• Drive Life Cycle Management for our Drug Product processes to ensure process robustness and continuous optimization.
• 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.
Qualifications:
The right candidate fulfills the following qualifications:
• University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 5 years of experience in the biotech industry
• Experience and in-depth knowledge of Drug Product development and manufacturing of sterile parenteral drugs/biologics and/or enteral drugs
• Experience of both sterile parenteral drugs and enteral drugs is a strong merit
• Experience of Drug Product Process and formulation development and process characterization.
• Experience with Technology transfers
• Experience and knowledge of cGMP manufacturing of biologics and industry regulatory standards.
• Experience of cross functional team work.
• 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.
• Ability and enjoy working in a volatile environment
• Ability to collaborate with different parties both external and internal
• Highly self-motivated and ability to drive activities
Skills and 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 have strong capabilities to analyze complex information or situations and provide sound solutions and to identify, adapt and implement new technologies. You have the 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.
Contact Application & More information.
You will report to Susanne Wood, Head of Manufacturing Science and Technology, contact information
susanne.wood@sobi.comThe position is based in Stockholm (Solna or Hornsberg). We will interview candidates continuously with a pause during summer holiday and welcome your application today! If you are interested in applying for this position, please submit your CV and cover letter through our web page
www.sobi.comPubliceringsdatum2019-10-21Så ansöker duSista dag att ansöka är 2019-11-20
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 4868456
Observera att sista ansökningsdag har passerat.