Senior Process Manager MSAT

4 weeks ago

Cambridge, United Kingdom Sobi - Swedish Orphan Biovitrum AB (publ) Full time

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Job Description

Role & Function

The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobi’s clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage. Manufacturing Science and Technology (MSAT) is part of the Global CMC, Science & Technology Department (GCSAT).

GCSAT is responsible for optimization and life cycle management of Sobis clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant, reliable, cost effective and sustainable manufacturing of our products now and in future.

This specific role will take care of biological Drug Substance activities, mainly related to Upstream.



Key Responsabilities

  • Subject matter expert (SME) for Biological DS.
  • Process owner of Biological DS validation for Sobi products.
  • Identify, lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
  • Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs.
  • Review and supervise set up, execution and documentation of technical studies, qualifications and validations.
  • Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs.
  • Issue, review and approve applicable internal and external SOP’s and manufacturing instructions.
  • Review and supervise set up, execution and documentation of technical studies, qualifications, and validations.
  • Contribute during set up of new analytical specifications and stability programs and review changes thereof.
  • Write and review applicable sections of the APR/PQR.
  • Responsible for continuous process verification (CPV) of the products in responsibility area.
  • Input and review applicable sections in registration files, variations, and market expansion.
  • Support in sourcing evaluation of new Biological DS contract manufacturers and participation in developing supply and quality agreements.
  • Lead the technical part of a product transfer, scale up activities, validations and oversees manufacturing of Biological DS processes at external manufacturers for Sobi projects in clinical and commercial phase.
  • Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost, or yield improvement.
  • Involved in due diligence of potential in-sourcing of new products.

Qualifications

Education/Learning Experience/Work Experience

  • University education in Chemistry, Biology, Biotechnology, Pharmacy or similar.
  • +5 years of experience of development and manufacturing of Biological DS for clinical and commercial use.

Skills/Knowledge/Languages

  • Scientific and technical background of CMC development and manufacturing of Biological Drug Substance.
  • Recognizedexpert in biologics drug substance manufacturing.

Personal Attributes

  • Problem solving, creativity, and flexibility with regards to evolving priorities.
  • Fulfilment of all Sobi’s CARE values.
  • Ability to act independently and take initiative.
  • Good communication skills, oral/written and listening.
  • Strong team player.
  • Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker.
  • Experience of regulatory guidelines, regulatory authorities’ communication and file documentation.
  • Fluent in English

Additional Information

To be successful in this role you are positive, driven, flexible and enjoy working in a fast-changing environment. You have project management and coordination skills and an ability to bring clarity and context to complex questions to teams and stakeholders. Strong team working and communication skills are also required. In addition, you must demonstrate behaviours in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

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