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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
Ro
Job Source: Sobi - Swedish Orphan Biovitrum AB (publ)
Job DescriptionPuriFire EnergyPuriFire is a thermochemical technology start-up pioneering the production of renewable fuels, chemicals and gases. Our patented hydrothermal treatment technology converts various forms of waste carbon using heat and pressure. Our objective is to become the lowest-cost green methanol before 2030. Developed by a dedicat
PuriFire Energy
PuriFire is a thermochemical technology start-up pioneering the production of renewable fuels, chemicals and gases. Our patented hydrothermal treatment technology converts various forms of waste carbon using heat and pressure. Our objective is to become the lowest-cost green methanol before 2030.
Developed by a dedicated team of sc
Are you meticulous and take pride in maintaining clean and safe work environments? Do you have experience with industrial cleaning processes? If you’re answering 'yes', then our latest opportunity as an IBC Process Cleaner could be your next career move! My client is seeking a dedicated individual to join their team. In this vital role, you'll ens
Do you have a keen eye for detail and a passion for operational excellence? Are you looking for a role where you can be part of a critical manufacturing process? If so, then the position of Process Operative at my client's facility might just be the next step in your career!As a Process Operative, you will play a crucial role in the production lin
Are you meticulous and take pride in maintaining clean and safe work environments? Do you have experience with industrial cleaning processes? If you’re answering 'yes', then our latest opportunity as an IBC Process Cleaner could be your next career move! My client is seeking a dedicated individual to join their team.
In this vital role, you'll ens
Do you have a keen eye for detail and a passion for operational excellence? Are you looking for a role where you can be part of a critical manufacturing process? If so, then the position of Process Operative at my client's facility might just be the next step in your career!
As a Process Operative, you will play a crucial role in the production li
Are you looking for a role with genuine career progression and opportunity? Are you looking for that next step in your accounting career?
I am currently working with a 7 Partner Firm with offices in Huntingdon that are seeking a Manager or Senior Manager within General Practice, salary is negotiable and dependent upon experience, but would likely b
Job Source: Rutherford Briant
Senior Process Manager MSAT
Cambridge
Job DescriptionSobi 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 DescriptionRole & FunctionThe 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 ResponsabilitiesSubject 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.QualificationsEducation/Learning Experience/Work ExperienceUniversity 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/LanguagesScientific and technical background of CMC development and manufacturing of Biological Drug Substance.Recognizedexpert in biologics drug substance manufacturing.Personal AttributesProblem 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 EnglishAdditional InformationTo 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.