Scientist, MSAT

3 months ago

London, United Kingdom Orchard Therapeutics Full time

 

Reporting to:           Senior Manager DS/DP MSAT

 

Location:                  London

 

Job Summary

This role, within the Manufacturing Sciences and Technologies (MSAT) is pivotal in ensuring seamless communication and operational manufacturing readiness between Orchard Internal functions (MSAT, Supply Chain, GMP QA) and Orchard CDMO partner(s). This position will report into the head of DS/DP MSAT and will also have responsibilities with the head of Vector MSAT. The role holder will be responsible for managing, coordinating and leading manufacturing documentation technical reviews and approvals, in collaboration with relevant SME’s, for both Viral Vectors and Drug Products, ensuring accurate and cohesive translation of the technical control strategy documents into manufacturing and/or production documentation (batch records, sampling plans, testing strategies). In addition, the role holder will manage and coordinate technical reviews of manufacturing deviations, changes or other quality events related to manufacturing activities as required. The incumbent with strong knowledge of manufacturing processes and excellent scientific background in CGT will support MSAT DS/DP and LVV technical leads for Continued Process Verification (CPV) efforts through data collection, structural organisation and trend analysis for commercial program and will establish initial manufacturing data collection and repository for late-stage program transition into MSAT ensuring data integrity is maintained throughout the process.

 

The successful candidate will be a highly motivated, detail-oriented, organized MSAT scientist. The individual will have relevant experience in Cell Gene Therapy products particularly in viral vector and/or cellular therapies products. Experience in experimental study design, statistical data and trend analysis is essential.

 

The post-holder will have a good understanding of GMP, statistical methods, QbD approaches and quality control of data, with excellent attention to detail, communication, presentation, and organizational skills, effective troubleshooting ability, and the ability to work independently and as part of a team.

  

Key Responsibilities

·         Liaison and coordination for manufacturing readiness:

o   MSAT point of contact between internal teams and CDMO to ensure manufacturing readiness

o   Facilitate planning of manufacturing documentation updates in-line with production schedule and requirements

o   Participate in weekly manufacturing internal meeting and regular meetings with CDMO

o   Coordinate timely delivery of manufacturing documentation in-line with Manufacturing schedule

o   Manage and coordinate technical review of manufacturing deviation, changes or other quality events related to manufacturing activities and ensure proper escalations and documentation resolution

o   Review manufacturing documentation and ensure alignment with current process description and control strategy

·         Process Data Analyst:

o   Support CPV efforts by ensuring accurate and timely data collection from manufacturing processes

o   Owner of the data bases design, maintenance and structural organisation

o   Actively contribute to development of manufacturing database and tools

o   Support statistical analysis on manufacturing data to identify trends, variability and opportunities for process improvement

o   Actively contribute to Trending meetings or committees

o   Generate reports and visual supports as needed

o   Maintain data integrity and ensure compliance with data management as per internal SOP and in accordance with regulations.

Requirements

Required knowledge

·         Experience in Cell and Gene Therapy in one or more of the following areas: lentiviral vectors, plasmids & cell banks, haematopoietic stem cell biology

·         Experience working with CDMO and/or third parties

·         Good knowledge of GMP

·         Good knowledge and understanding of the QbD principles

 

Skills & Abilities

·         Sound scientific and technical proficiency

·         Trouble-shooter, problem solver mentality

·         Excellent communicator 

·         Effective collaborator able to build strong relationships with both internal and external stakeholders

·         Action oriented

·         Ability to operate in a fast-paced, multi-disciplinary industrial environment.

 

Education and Experience

·         At minimum, a BSc. in a relevant scientific discipline, such as Chemistry, Biochemistry, Molecular Biology, Cell Biology, Chemical Engineering, or another relevant field,

·         Relevant experience in the biotechnology or pharma industry within a MSAT, production or process development function

  • Scientist, MSAT

    3 months ago

    London, United Kingdom Orchard Therapeutics Full time

    Reporting to: Senior Manager DS/DP MSATLocation: LondonJob Summary This role, within the Manufacturing Sciences and Technologies (MSAT) is pivotal in ensuring seamless communication and operational manufacturing readiness between Orchard Internal functions (MSAT, Supply Chain, GMP QA) and Orchard CDMO partner(s). This position will report into the head of...

  • Scientist, MSAT Specialist

    4 days ago

    London, Greater London, United Kingdom Orchard Therapeutics Full time

    Job SummaryThis role is pivotal in ensuring seamless communication and operational manufacturing readiness between internal functions and CDMO partners. The position will report into the head of DS/DP MSAT and will also have responsibilities with the head of Vector MSAT.Key ResponsibilitiesLiaison and coordination for manufacturing readiness:MSAT point of...

  • Scientist, MSAT Specialist

    4 days ago

    London, Greater London, United Kingdom Orchard Therapeutics Full time

    Job SummaryThis role is pivotal in ensuring seamless communication and operational manufacturing readiness between internal functions and CDMO partners. The position will report into the head of DS/DP MSAT and will also have responsibilities with the head of Vector MSAT.Key ResponsibilitiesLiaison and coordination for manufacturing readiness:MSAT point of...

  • Senior Scientist, MSAT

    3 months ago

    London, United Kingdom Orchard Therapeutics Full time

    Reporting to: Senior Manager, MSATLocation: LondonJob Summary Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, is looking for a dynamic and experienced Senior Scientist in the Drug Substance (DS)/Drug Product (DP) Manufacturing Sciences & Analytical...

  • Senior Scientist, MSAT

    1 day ago

    London, Greater London, United Kingdom Orchard Therapeutics Full time

    About the RoleWe are seeking a highly experienced Senior Scientist to join our Manufacturing Sciences and Analytical Technologies (MSAT) team at Orchard Therapeutics. As a key member of our team, you will play a critical role in supporting the late-phase DS/DP MSAT team and process development, validation, and maintenance of all DS/DP manufacturing...

  • Senior Scientist, MSAT

    1 day ago

    London, Greater London, United Kingdom Orchard Therapeutics Full time

    About the RoleWe are seeking a highly experienced Senior Scientist to join our Manufacturing Sciences and Analytical Technologies (MSAT) team at Orchard Therapeutics. As a key member of our team, you will play a critical role in supporting the late-phase DS/DP MSAT team and process development, validation, and maintenance of all DS/DP manufacturing...

  • Cell Process Scientist

    3 weeks ago

    London, Greater London, United Kingdom Northreach Full time

    Position OverviewNorthreach is a progressive recruitment agency dedicated to linking organizations with exceptional talent in the Advanced Therapies field. Our goal is to deliver a smooth and tailored recruitment journey for both clients and candidates, fostering a workplace that promotes equality, innovation, and professional development.Role SummaryWe are...

  • Cell Process Scientist

    3 weeks ago

    London, Greater London, United Kingdom Northreach Full time

    Position OverviewNorthreach is a forward-thinking recruitment agency specializing in connecting organizations with exceptional talent in the Advanced Therapies field. Our goal is to deliver a smooth and tailored recruitment journey for both clients and candidates, fostering a workplace that promotes equality, innovation, and professional development.Role...

  • MSAT Scientist

    3 weeks ago

    London, Greater London, United Kingdom Orchard Therapeutics Full time

    About Orchard Therapeutics Orchard Therapeutics is a leading gene therapy company dedicated to transforming the lives of patients with serious diseases. We are committed to developing innovative and life-changing therapies that address unmet medical needs. Role Overview We are seeking a highly motivated and detail-oriented MSAT Scientist to join our...

  • Lead Scientist in Cell Therapy Manufacturing

    3 weeks ago

    London, Greater London, United Kingdom Northreach Full time

    Position OverviewJob Title: Lead Scientist - Cell Therapy ManufacturingJob Type: Full-TimeNorthreach is a forward-thinking recruitment agency dedicated to linking organizations with exceptional talent in the Advanced Therapies domain. Our goal is to deliver a smooth and tailored recruitment journey for both clients and candidates, fostering a workplace that...

  • Lead Scientist in Cell Therapy Manufacturing

    3 weeks ago

    London, Greater London, United Kingdom Northreach Full time

    Position OverviewJob Title: Lead Scientist - Cell Therapy ManufacturingJob Type: Full-TimeNorthreach is a forward-thinking recruitment agency dedicated to linking organizations with exceptional talent in the Advanced Therapies domain. Our goal is to deliver a smooth and tailored recruitment journey for both clients and candidates, fostering a workplace that...

  • R&D Scientist/Engineer

    2 weeks ago

    London, United Kingdom Touchlight Full time

    Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need for a better quality, faster and more robust DNA manufacturing technology....

  • R&D Scientist/Engineer

    3 weeks ago

    London, United Kingdom Touchlight Full time

    Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need for a better quality, faster and more robust DNA manufacturing technology....

  • Process Development Scientist/Engineer

    12 hours ago

    London, Greater London, United Kingdom Touchlight Full time

    Job DescriptionCompany OverviewTouchlight is a leading Contract Development and Manufacturing Organization (CDMO) specializing in DNA manufacturing technology. Our mission is to enable the next generation of genetic medicines through innovative and scalable solutions.Job SummaryWe are seeking a highly skilled Process Development Scientist to join our CMC...

  • Process Development Scientist/Engineer

    9 hours ago

    London, Greater London, United Kingdom Touchlight Full time

    Job DescriptionCompany OverviewTouchlight is a leading Contract Development and Manufacturing Organization (CDMO) specializing in DNA manufacturing technology. Our mission is to enable the next generation of genetic medicines through innovative and scalable solutions.Job SummaryWe are seeking a highly skilled Process Development Scientist to join our CMC...

  • Manufacturing Scientist/Senior

    3 weeks ago

    London, Greater London, United Kingdom Northreach Full time

    Position OverviewNorthreach is a leading recruitment agency dedicated to connecting organizations with exceptional talent in the Advanced Therapies industry. Our goal is to deliver a tailored and efficient recruitment experience for both clients and candidates, fostering a workplace that promotes equality, innovation, and professional development.About the...

  • Manufacturing Scientist 2

    4 months ago

    London, United Kingdom Northreach Full time

    Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.About Us:My client are a...

  • Process Development Scientist

    1 month ago

    London,, UK, United Kingdom Touchlight Full time

    Touchlight is focussed on the enzymatic synthesis of novel DNA formats. Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need...

  • Process Development Scientist

    2 weeks ago

    London, United Kingdom Touchlight Full time

    Touchlight is focussed on the enzymatic synthesis of novel DNA formats. Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need...

  • Process Development Scientist

    5 days ago

    London, United Kingdom Touchlight Full time

    Touchlight is focussed on the enzymatic synthesis of novel DNA formats. Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need...