API Development Manager - Oxford
Jason Johal at CK Science is currently recruiting for an API Development Manager to join a world-class specialty biopharmaceutical business focused on allergy and asthma. The Company has an established commercial infrastructure, marketed products, a pipeline of near-term therapies and a portfolio of next generation treatments targeting multi-$billion market opportunities. This role is offered on a full time permanent basis at their site in Oxfordshire.
Your main responsibilities in this role will be to:
- Act as the Pharmaceutical Sciences Lead for assigned development programmes
- Oversee technical and quality oversight of outsourced analytical development, characterisation and validation activities undertaken by selected analytical suppliers
- Identify, develop and qualify/validate methodology suitable for the phase appropriate characterisation, release and stability testing of peptide products, in line with regulatory expectations
- Design analytical studies and write protocols to support formulation and pharmaceutical process development and manufacturing activities
- Interpret complex analytical data sets, specifically peptide LC-MS data for the evaluation and tracking of process related impurities and degradants
- Support the establishment, characterisation and maintenance of analytical reference standards for API and drug product
- Support for the preparation of IMPD / IND and other regulatory documents by generating analytical sections relating to API and drug product characterisation and release
- Assist in the investigation and root cause analysis of analytical quality issues, including OOT/OOS results, generated during a study and execution of associated CAPA according to internal quality procedures
You are required to have the following qualifications, skills and experience:
- A strong relevant technical background including API & Drug substance experience
- Significant relevant analytical development experience in a GxP regulated environment
- A strong analytical background with particular experience in HPLC / LC-MS analysis of peptides and proteins; experience of Waters Empower data system would be an advantage
- Proven experience of method development and validation activities in accordance with ICH guidelines / industry best practice, in a range of analytical techniques; a thorough understanding of the relevant ICH guidelines is expected
- A thorough understanding of GMP/GLP quality standards
- A broad range of the analytical techniques, including those considered state of the art, and their application to the testing and characterisation of peptide and protein drug products
- Experience of dealing with CMO's
- Experience of working within cross-functional project teams
- GMP & Regulatory knowledge
- A PhD, Masters, Bachelors or equivalent degree in a relevant scientific discipline (or equivalent)
If successful, you will be joining a company with a broad-based development pipeline including a range of treatments for allergy and asthma. Their most advanced next-generation immunotherapy is currently in phase III testing and is the first in a new class of treatments, Synthetic Peptide Immuno-Regulatory Epitopes (SPIREs). Three other SPIREs, have completed clinical proof-of-concept phase IIb studies and their lead asthma product targets substitution of GSK's Flixotide® pMDI, and was filed for regulatory approval in H2 2014.
For more information or to apply for this Analytical Development Manager position please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST34822 in all correspondence.