External Manufacturing Manager, Drug Product

External Manufacturing Manager, Drug Product

Sobi

Stockholm, Sweden

The External Manufacturing Department at Sobi is looking to recruit an External Manufacturing Manager with special expertise within Drug Product Manufacturing. For this position you will be responsible for Drug Product Manufacturing at third-party contract manufacturing organizations (CMOs) and apply your expertise in Drug Product cGMP clinical and commercial 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. The position can either be a permanent position or a job rotation for at least 1.5 years. 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 Drug Product, you will be subject matter expert (SME) for Drug Product manufacturing processes and responsible and main contact person for Drug Product CMO´s. The Products are mainly sterile parenteral drugs e.g. recombinant proteins and mAbs (Biologics).

Main responsibilities include:

  • Be SME for Drug Product processes and activities at external manufactures. This includes; being technical and scientific lead for Drug Product manufacturing processes during clinical and commercial manufacturing, tech transfers, scale up and validations. Life cycle management of Drug Product processes to keep processes robust and in a compliant state and propose process optimizations;
  • 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;
  • Coordinate and drive cGMP manufacturing and uninterrupted supply of 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;
  • Be business responsible for external 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.

Qualifications:

The right candidate fulfills the following qualifications:

  • University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 5-10 years of experience in the biotech industry;
  • Experience and in-depth knowledge of Drug Product development and manufacturing of sterile parenteral drugs/biologics;
  • Extensive experience of and knowledge of cGMP manufacturing of biologics and industry regulatory standards;
  • 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.

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.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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