Senior Scientist

Ipsen; Wrexham; On-site; GBP 40,000 - 70,000; Full time

Job summary

Ipsen is seeking a Senior Scientist to join our Biologics Pharmaceutical Development team in Wrexham. This role involves developing, implementing, and validating analytical methods to ensure quality control of novel products. It's a hands-on position requiring strong analytical experience in biopharmaceutical development. Join us in making a meaningful impact in patient care!

Qualifications

• Proven track record in driving process improvement.
• Experience with biological medicinal products.
• Familiarity with Good Manufacturing Practice standards.

Responsibilities

• Develop analytical methods to ensure product quality and safety.
• Conduct analytical testing for novel biologic products.
• Contribute to regulatory documentation.

Skills

Analytical techniques

Communication

Process improvement

Education

BSc in relevant scientific discipline

MSc or PhD in relevant area

Tools

HPLC

ELISA

HPSEC

cIEF

SDS-CE

Job description

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Due to our company's growth and expansion, we are seeking an experienced Senior Scientist to join our Biologics Pharmaceutical Development (BPD) team based in Wrexham. This is an exciting opportunity where you will be responsible for the development, implementation and validation of analytical methods for use in quality control and stability testing of novel products in our development pipeline.

In this high-visibility hands-on role, you will have the chance to work with various teams within our BPD function, acting as an analytical SME, contributing to study design, and writing protocols. This is a fantastic opportunity for someone with a strong analytical background and experience with methods for measuring key quality attributes of proteins and toxins to join our dynamic team.

Role Responsibilities

• Develop and deliver analytical methods to ensure product quality and patient safety.
• Work within the Analytical Development group to meet CMC goals and ensure efficient communication.
• Apply experience to various biological assets, including ADCs, mAbs, bispecifics, and toxins.
• Conduct analytical testing for novel biologic products from Phase I to Phase III.
• Utilize techniques such as HPLC, ELISA, HPSEC, cIEF, and SDS-CE for testing.
• Support the development of bioassay formats to understand structure/function relationships.
• Communicate effectively with key partners and collaborators.
• Contribute to regulatory documentation and support external collaborations.
• Maintain facilities, procedures, and documentation aligned with development needs.
• Select and develop new technologies to enhance analytical capabilities.
• Lead and implement analytical improvement programs and processes.
• Prepare, review, and approve various documentation as required.
• Apply knowledge of ICH guidelines to analytical activities.
• Work in compliance with GxP/EHS requirements.
  
  

Knowledge & Experience (essential)

• BSc in relevant scientific discipline
• Experience in analytical techniques for Biological medicinal products.
• Experience in biopharmaceutical development
• Technical expertise in at least one or more of the following analytical techniques quantitative analysis by HPLC, plate-based immunodetection assays (e.g. ELISA), purity techniques such as HPSEC, capillary isoelectric focusing (cIEF) and SDS-capillary electrophoresis (SDS-CE).
• Proven track record in driving process improvement and innovation.
• Skilled and adaptable communicator across a broad grade range of staff expertise, able to present and articulate complex technical topics to technical and non-technical stakeholders.
  
  

Knowledge & Experience (preferred)

• MSc in relevant area or PhD
• Previous experience working to Good Manufacturing Practice standards.
• Familiarity with applying DOE and QBD principles to analytical method development.
• Experience in mammalian cell culture and biological assay development.
• Knowledge of biostatistics and data processing as it applies to bioassays, including non-linear curve fitting using 4 and 5-PL models and strategies for similarity/parallelism testing of bioassay curves.
  
  

Join Our Award-Winning Team at Ipsen Wrexham

At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.

With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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