Director of Manufacturing Science and Technology

Director of Manufacturing Science and Technology

Sobi

Stockholm, Sweden

Sobi is seeking to recruit a Director of Manufacturing Science and Technology (MS&T). MS&T is part of the Global Manufacturing department of Technical Operations at Sobi. MS&T is the powerhouse of manufacturing science and technology and drives development, optimization and life cycle management of our clinical and commercial manufacturing processes. MS&T ensures compliant, reliable, cost effective and sustainable manufacturing of our products now and in the future. MS&T is a relatively newly formed team made up of experienced and dedicated personnel. The MS&T team is primarily based in Stockholm.

Key Responsibilities:

The Head of MS&T is responsible for managing the MS&T department. The duties includes:

  • Continuing to build up and establishthe structure for this new function in Global Manufacturing and thus ensuring that the MS & T department is run according to industry best practice;
  • Leadership offer for the MS&T team, developing team members and building and maintaining a high-performing team of experienced and engaged co-workers;
  • Ensuring a team with the relevant in depth senior scientific and technical expertise regarding manufacturing of Drug Substance/API, Drug Product (including container closure and device), Finished Goods and IMP to ensure reliable and sustainable delivery of clinical and commercial products now and in the future. The team is responsible for developing and includes expertise in both biologic and small molecule products;
  • Ensuring a team with cGMP know-how and upholding relevant expertise of current and future legislation while maintaining Sobis internal and external processes in a compliant and validated state;
  • Accountability for the efficient leadership of life cycle management of our clinical and commercial processes and upholding and delivering on strategic plans to ensure process robustness as well as supporting sustainable SPC/COGS development for our products;
  • Responsibility for maintaining efficient and senior SME support for complex Drug Substance/API, Drug Product, Finished Goods and IMP manufacturing issues, changes, transfers and validations (biologics and small molecules);
  • Responsibility for ensuring efficient scientific support for continuous process verifications and process data trending reviews;
  • Ensuring ownership and support for CMC regulatory file documentation for initial applications, variations and new market entries. Responsibility for strategic oversight of the CMC regulatory files for our products.

Qualifications:

The ideal candidate will possess the following qualifications:

  • University degree in chemistry and/or biotechnology and/or process engineering;
  • At least 15 years of experience in the pharmaceutical/biotech industry;
  • Strong scientific and technical background from CMC development and manufacturing of Drug Substance, API and Drug Product;
  • Experience and know-how of cGMP manufacturing and industry regulatory standards;
  • Preferably in-depth knowledge of biologics manufacturing and experience of API/small molecule manufacturing and Finished Goods and IMP manufacturing;
  • Proven track record of effective collaborative leadership, managing and developing teams and leaders;
  • Experience of building and implementing new organisations and structures;
  • Experience of working in a global and cross functional matrixed environment and evidence of successful collaboration with internal and external parties;
  • Experience of working with CMOs would be an advantage.

Personal attributes:

  • Accountable, goal oriented, ability to act independently and take the initiative with a can-do attitude;
  • Engaging and strong interpersonal skills, organizational and communication skills and cross functional collaboration skills;
  • Ability to act, engage and deliver in a changing environment;
  • Analytical thinker and scientifically driven when required;
  • Excellent verbal and written communication skills in English and ability to communicate in a business environment.

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© EuroJobsites 2020

EuroJobsites is a 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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