ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Adepto Technical Recruitment Ltd
Cambridge
Technical Specialist (MSAT) Permanent role Location: Cambridge Salary: £35,000 - £50,000 Benefits: Personal Days, Private Medical Cover, Enhanced MAT/PAT Leave, Bonus & more An exciting opportunity for an established MSAT Technical Specialist has arisen to join a global leader in contract manufacturing for medical device, diagnostics, and drug
Job Source: Adepto Technical Recruitment LtdJohnson Matthey Plc
Royston, Hertfordshire
Vacancy: Process Commissioning Manager Location: Royston Job Family: Scientist As the process commissioning manager within the JM Commissioning Team reporting to the commissioning director, supporting a FEED / EPC Contractor from issue for design phase to commissioning for 3CR. As part of the commissioning team the incumbent will be responsible
Job Source: Johnson Matthey PlcBennett and Game Recruitment LTD
Sandy
Process Engineer required. Our client is a well-established manufacturer of electronic components based in the Sandy area. Due to ongoing success and growth of the business they are seeking an enthusiastic Process Engineer to join the team. Process Engineer Position Overview Identifying and implementing areas for continual improvements to the pro
Job Source: Bennett and Game Recruitment LTDReed
Cambridge
Role: Process Engineer if you have any knowledge or experience in designing and gas absorptions don't hesitate, click apply! position overview we are currently looking for a process engineer, able to combine creativity and objectivity with solid first principles in process design to integrate novel porous materials into a gas separation and storage
Job Source: ReedBennett & Game Recruitment
Sandy
Process Engineer required. Our client is a well-established manufacturer of electronic components based in the Sandy area. Due to ongoing success and growth of the business they are seeking an enthusiastic Process Engineer to join the team. Process Engineer Position Overview Identifying and implementing areas for continual improvements to the produ
Job Source: Bennett & Game RecruitmentMicroTECH Global Ltd
Cambridge
Responsibilities: Work within a clean room environment to process the products of low volume R&D batches and higher volume repetitive processing of established products, able to flexible in working on new processes to develop operating procedures in tandem with process engineers. Process wafers with care and attention, to deliver high yields and lo
Job Source: MicroTECH Global LtdReed
Cambridge
Role: Process Engineer if you have any knowledge or experience in designing and gas absorptions don't hesitate, click apply! position overview we are currently looking for a process engineer, able to combine creativity and objectivity with solid first principles in process design to integrate novel porous materials into a gas separation and storage
Job Source: ReedRutherford Briant
Huntingdon
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 BriantCambridge, England, United Kingdom
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.
Senior Process Manager MSAT jobs in Cambridge, England, United Kingdom
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.