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Senior Analytical Chemistry Manager (Ref 4267)

Artios Pharma is currently recruiting a Senior Analytical Chemistry Manager to join our expanding team. This is an excellent opportunity to join a world class research team in a dynamic, expanding biotech company based south of Cambridge, UK. Artios is focused on identifying and developing cancer treatments by exploiting novel targets within the DNA damage response (DDR), a scientific area of high expectation following the success of PARP inhibitors in the clinic.

The company is actively working on an exciting portfolio of unique DNA repair projects. We currently have two programmes in early phases of clinical development. These phase 1/2a studies are evaluating the small-molecule ATR inhibitor ART0380 and the first-in-class Pol -Theta inhibitor ART4215 in patients with advanced or metastatic solid tumours.

Outline of the role

The Senior Analytical Chemistry Manager will be responsible for managing analytical chemistry activities relating to Drug Substance and Drug Product testing in support of development and cGMP production across the portfolio of Artios development compounds, supporting projects from pre-clinical to clinical stages.  The Senior Analytical Chemistry Manager should have experience of working at the bench in a pharmaceutical analytical development or QC environment supporting Drug Substance and/or Drug Product production including hands-on experience chromatographic and spectroscopic techniques, and also ideally solid state techniques.  The candidate also must have experience in working in a GMP laboratory environment, and demonstrate the accompanying attention to detail and analytical mindset to ensure accuracy of documentation and calculations contributing to right first time data.  Strong communication and project management skills are essential alongside, technical and quality knowledge with demonstrated experience of managing internal and external international partners is essential.

The Senior Analytical Development Manager will have the responsibility for the day-to-day oversight of analytical activities at CDMOs involved in the Drug Substance and Drug Product development and production, working closely with colleagues with primary responsibly for the development and production of Drug Substance and Bulk Drug Product.

The role will suit a pharmaceutical analytical chemist wishing to transition away from the bench and gain wider experience in CMC drug development and project management.


  • Management and coordination of analytical chemistry activities to support testing of Drug Substance and Drug Products and also GMP starting materials and components where applicable.
  • Responsible for the management and co-ordination of analytical activities at CDMOs, working with Artios Drug Substance and Drug Product delivery leads and external analytical development consultants (where required).
  • Work together with Drug Substance and Drug product colleagues, consultants and CDMOs to identify work packages to be conducted based on the program concerned.  This includes methods to be developed, validation requirements of these methods, reference standards required and the characterisation of these and stability study requirements.
  • Communication of project requirements to external vendors and management of those vendors to the required deliverables, ensuring the financial parameters of contracts are upheld.
  • Review validation protocols and reports, stability protocols and reports plus in-house specifications generated by CDMOs
  • Author Artios specifications and specification justifications for Custom Starting Materials, Drug Substance, Drug Products and components where required
  • Author Retest/Shelf-Life justification and shelf-life statements for Drug Substance and Drug Products including overseeing the tabulation, trending and written interpretation of stability data, which will also form part of regulatory dossiers. Also author acceptable temperature excursion memos.
  • Author reference standard characterisation and retest protocols supporting both CMC and bioanalytical requirements.
  • Assist with authoring and review the Module 3 analytical chemistry sections of IND and IMPD
  • Generate and see through to completion Quality Events as they apply to analytical chemistry activities e.g. laboratory investigations, out of specification, out of trend including completion of notification forms and reports associated with these.
  • Consult with and advise Artios CMC Project Co-ordinator to ensure analytical materials are always in place for scheduled work and assigned appropriate retest and/or expiry dates. Work with CMC Project Co-ordinator to ensure the controlled management of reference standard shipments in accordance with storage temperatures.
  • Ensure testing is conducted in compliance with Good Manufacturing Practices (GMP) and in accordance with the requirements of the Quality Technical Agreement and relevant standard operating procedures (SOPs), and regulatory requirements.
  • Part of team involved in qualification of new suppliers to ensure that analytical chemistry requirements are being met, working closely with QA Team. Contributes to Quality Technical Agreements to be put in place with these CDMOs.
  • Actively involved in change control processes especially in relation to changes in analytical methods and wider impact of these with respect to impact on Drug Substance and/or Product, regulatory filing and quality implications.
  • Working closely as key member of CMC Team working with Drug Substance, Drug Product and IMP Supplies colleagues as well as part of cross-functional team for study management activities.
  • Ensures the contemporaneous management and filing of development protocols, reports and data within Artios document management system including the Product Specification File and external vendor document sharing sites to ensure requirements of Quality Technical Agreement and Clinical Trials Regulation are being met.
  • Contributes to project related budgets in the areas responsible for.
  • Staying up to date with relevant cGMPs and other regulatory requirements and guidelines.
  • Actively contributing towards the development and implementation of process improvement.

Qualifications and Experience

  • Bachelor or Masters in Chemistry/Analytical Chemistry related subject
  • Proven experience in pharma, biotech or CDMO in analytical development and/or QC role
  • Detailed technical knowledge and experience of common pharmaceutical development techniques including HPLC, GC/GC-HS, FT-IR, UV spectrometry, dissolution testing. Preferably also NMR, XRPD, DSC, TGA and DVS.  .
  • Demonstrated current knowledge of cGMP and working in a pharmaceutical Quality Management System.
  • Demonstrated knowledge of ICH quality guidelines as they related to method validation, stability testing, specifications
  • High degree of attention to detail and accuracy
  • Demonstrated experience in successfully managing projects in a proactive manner
  • Demonstrated experience with multiple development projects
  • Experience of working with external analytical chemistry vendors to ensure optimal delivery to time, cost and quality
  • Strong technical project management skills, ideally with experience of working with project management tools e.g. MS Project, Smartsheet
  • Strong interpersonal skills and experienced in presenting to senior management
  • Good computing skills in MS Office suite software
  • Strong team player with good motivational skills, and ability to work independently
  • Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external service providers and consultants
  • Ability to handle complex information

This is a permanent position, offering an attractive salary & benefits package.   If you have the right background, then please apply by uploading your CV with a covering letter quoting Ref 4267.

Please apply using the link below and ensure that you click ‘upload’ before you finish your application.

In order to comply with UK Employment Law, all applicants must have the Right to Work in the UK or if from the EU, subject to receiving a relevant Skilled Worker Visa to work in the UK.

Due to the high volume of applications we receive, if you do not hear from us we will not be inviting you to interview on this occasion.

No agencies, thank you.