Scientist – Cdmo Management, Cell Engineering And Cmc, Biologics R&d Center

Cambridge, ENG, GB, United Kingdom

Job Description

The Biologics CMC group is a unit within the newly established Orion Biologics R&D UK Center whose main responsibility is to discover and develop biologics for clinical use from early research into clinical development and launch.


Orion Pharma is establishing a new Biologics Research & Development Center in the vibrant biomedical ecosystem of Cambridge, UK. The Biologics R&D Center represents a central piece in the long-term vision of expansion into biologics modalities by Orion Pharma. The Center's mission is to accelerate the company's biologics research and development efforts.


The Biologics R&D Center will complement Orion's existing R&D efforts in Finland, where the company was founded in 1917. Currently, Orion possesses all of the functional capabilities necessary for small molecule discovery and development in Finland. Orion's expansion into Cambridge, UK marks a pivotal step in building future innovative biologics treatments, including multi-specific antibodies, Antibody Drug Conjugates (ADC), and Chimeric Antigen Receptor T cells (CAR-T).


Independently of geography, Orion Pharma is committed to upholding key Nordic values. The company has created a culture of straightforward and honest interactions, and its management emphasizes the balance of professional and home life, leading to happier and motivated employees. This motivation is key to meeting the company's bold mission of becoming a powerhouse of biologics discovery and development.


We are seeking a highly motivated and detail-oriented Scientist - CDMO Management, to join our growing Biologics CMC team at Orion's Cambridge R&D Center. This role will serve as a technical and operational liaison between Orion and its external CDMO partners to ensure the successful execution of outsourced activities across the biologics development pipeline, including process development, analytical method transfer, and GMP manufacturing.


Your responsibilities include the following:



Serve as the day-to-day technical contact for CDMO interactions across downstream, analytical, and fill-and-finish workstreams Support and coordinate technology transfer activities to and from CDMOs, including drafting/reviewing transfer plans and risk assessments Track and monitor project timelines, milestones, and deliverables for non-GMP and GMP campaigns Review and approve technical documentation such as batch records, protocols, CoAs, method transfer reports, and deviations Support investigations and root cause analysis of technical issues arising during CDMO execution Collaborate cross-functionally with internal CMC Managers, QA, and Regulatory Affairs to align on quality expectations and regulatory deliverables Ensure CDMO execution complies with GMP standards, quality agreements, and Orion's internal CMC strategy Facilitate regular technical meetings with CDMOs and document actions, issues, and resolutions Contribute to writing of protocols, technical reports, and documentation for regulatory submissions Ensure compliance with internal quality standards and maintain high levels of data integrity
The Scientist - CDMO Management will report to the Head of CMC group, Orion Pharma iMeds/R&D.


Description of our organization



Orion Pharma's Innovative Medicines are within its R&D organization. The organization employs top professionals in the field of drug discovery and development. There are around 400 professionals working in R&D. In addition to Cambridge, UK Biologics R&D Center, Orion R&D has offices in Espoo, Turku and Kuopio in Finland, in Nottingham, UK, and in New York, NY, USA.


We offer



This opportunity is to contribute to development of manufacturing cell lines within the Biologics CMC team at our new location in Cambridge, UK; this will be a unique opportunity for an enthusiastic antibody scientist to help further establish and advance a stable CHO cell line generation technology while we build a state-of-the-art Biologics powerhouse within Orion Pharma iMeds/R&D.


A highly innovative R&D pipeline and enthusiastic working environment with possibilities to use your own strengths to advance your competence and career.


The exciting potential to innovate and have an impact on future therapies for patients.


An excellent working atmosphere based on the appreciation of colleagues, continuous development, and mutual trust. Learn more about Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.


Our expectations:



Ph.D. or BS in Biotechnology, Cell Biology, Molecular Biology, or related field with 2+ to 4+ years, respectively, of relevant experience, Hands-on experience with CHO-based stable cell line development platforms (e.g., GS,DHFR, Transposon-based systems such as PiggyBac or Sleeping Beauty, site-specific integration (SSI) technologies) Proficiency in mammalian cell culture (suspension and adherent) under aseptic conditions Skilled in molecular biology methods, construct verification, and gene expression analysis Experience with analytical tools for protein quantification and quality assessment (e.g., ELISA, Octet, SDS-PAGE, etc.) Familiarity with principles of QbD, regulatory requirements, and GMP-readiness for cell banks An ability to create positive collaborations within the Research & Development team Demonstrated ability to meet performance targets and project initiatives Ability to assess and make decisions based on scientific data Excellent oral and written communication, interpersonal, and analytical skills

How to apply and additional information



If this opportunity excites you, we encourage you to apply! Please submit your cover letter and CV by July 13th, 2025.


We typically review applications already during the application period and may start interviewing candidates before the application deadline. Therefore, we invite you to send your application as soon as possible.


#LI-ORION


Unit description



Orion Pharma's Innovative Medicines are within its R&D organization. The organization employs top professionals in the field of drug discovery and development. There are around 400 professionals working in R&D. In addition to Cambridge, UK Biologics R&D Center, Orion R&D has offices in Espoo, Turku and Kuopio in Finland, in Nottingham, UK, and in New York, NY, USA.

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Job Detail

  • Job Id
    JD3329433
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Cambridge, ENG, GB, United Kingdom
  • Education
    Not mentioned