Senior Scientist, Analytical Sciences- Biopharmaceutical Development of RNA

at  AstraZeneca

Cambridge CB2 0AA, England, United Kingdom -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate30 Apr, 2025Not Specified30 Jan, 2025N/AMolecular Biology,Data Reporting,Regulatory Submissions,Communication Skills,Product Manufacturing,Biochemistry,Biotherapeutics,Life Science Industry,Constructive Feedback,Method Development,Ema,Characterization,Project Teams,Biophysics,BiotechnologyNoNo
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Description:

JOB TITLE: SENIOR SCIENTIST, ANALYTICAL SCIENCES- BIOPHARMACEUTICAL DEVELOPMENT OF RNA-BASED PRODUCTS

Location: Cambridge, UK
Salary: Competitive
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

SUMMARY OF THE GROUP:

In the Analytical Sciences – Physicochemical Development teams we enable the advancement of AZ’s biologics and new modalities portfolio using industry-leading analytical technologies. We are responsible for establishing platform methodologies and analytical strategies capable of supporting the pharmaceutical development of diversified modalities, that will become life-changing medicines.

EDUCATION & EXPERIENCE REQUIREMENTS:

Master’s or PhD in Biotechnology, Molecular Biology, Biochemistry, Biophysics or other relevant scientific field, with proven relevant experience in the Life Science industry. Years of industry experience will also be considered.

REQUIRED SKILLS:

  • Practical experience with the principles and concepts associated with the analysis and characterization of both protein- and nucleic acid-based therapeutics as well as with GLP/GMP production environment
  • Practical experience with electrophoresis- and liquid chromatography-based methods
  • Experience with Mass spectrometry-based methods and method development
  • Experience with assay automation, high-throughput methods and data reporting automation
  • Solid understanding of CMC development processes, including drug substance and drug product manufacturing, analytical development, and quality assurance
  • Experience authoring and reviewing CMC sections of regulatory submissions
  • Knowledge of global regulatory frameworks and guidelines (e.g., FDA, EMA, ICH)
  • Highly motivated, proactive individual with strong scientific curiosity and interest in continued learning. Team player with confidence to work with independently.
  • Detail orientated with excellent problem-solving and communication skills whom consistently meets agreed timelines

DESIRED SKILLS:

  • Knowledge of the biopharmaceutical development process
  • Experience with multi-attribute monitoring (MAM) methods for multiplexing biopharmaceutical quality attribute analysis
  • Evidence of driving innovative science, including publication in high quality scientific journals
  • Knowledge of programing tools/languages, such as R/Python
  • Experience working in a high-paced environment, collaborating and contributing to multiple projects and matrix teams.

SO, WHAT’S NEXT!

Please complete your application before 5th February 2025. We looking forward to hearing from you.

We are seeking a skilled and highly motivated Senior Scientist to join the Analytical Sciences – Physicochemical Development team in Cambridge, to work on Protein- and RNA-based therapeutics. The successful candidates will:

  • be responsible for the development of analytical capabilities for biotherapeutics that will support the product development from early stages through to clinical studies (including establishment or development of new technologies and/or methods)
  • be responsible for advancing our understanding of these molecules to ensure the appropriate Critical Quality Attributes are being monitored and managed
  • work in close collaboration with other teams, including those responsible for the process development, molecule design/engineering and product quality, as well as external collaborators and CMOs, to ensure efficient progress of the project(s)
  • oversee and perform method transfer to and/or from internal and external collaborators or CMOs
  • generate, interpret and report data independently, in a clear and concise manner, with an understanding of its implications within the overall context of the project
  • act as the CMC analytical characterization rep for assigned projects, providing strategic and operational input to cross-functional project teams
  • present and discuss the findings of experiments at meetings, or appropriate forums, and will incorporate constructive feedbac

Responsibilities:

We are seeking a skilled and highly motivated Senior Scientist to join the Analytical Sciences – Physicochemical Development team in Cambridge, to work on Protein- and RNA-based therapeutics. The successful candidates will:

  • be responsible for the development of analytical capabilities for biotherapeutics that will support the product development from early stages through to clinical studies (including establishment or development of new technologies and/or methods)
  • be responsible for advancing our understanding of these molecules to ensure the appropriate Critical Quality Attributes are being monitored and managed
  • work in close collaboration with other teams, including those responsible for the process development, molecule design/engineering and product quality, as well as external collaborators and CMOs, to ensure efficient progress of the project(s)
  • oversee and perform method transfer to and/or from internal and external collaborators or CMOs
  • generate, interpret and report data independently, in a clear and concise manner, with an understanding of its implications within the overall context of the project
  • act as the CMC analytical characterization rep for assigned projects, providing strategic and operational input to cross-functional project teams
  • present and discuss the findings of experiments at meetings, or appropriate forums, and will incorporate constructive feedback


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

IT Software - System Programming

Clinical Pharmacy

Phd

Proficient

1

Cambridge CB2 0AA, United Kingdom