Senior Scientist, Analytical CMC

4 weeks ago

Didcot, United Kingdom Barinthus Biotherapeutics Full time

Senior Scientist (Analytical CMC)

Reports To: Director, Analytical CMC

Location: Laboratory in Harwell, Oxfordshire.

Main purpose of job:

As a member of the team, the Senior Scientist is expected to lead development of multiple analytical techniques across a broad range of assays that are required to support testing of Barinthus Biotherapeutics immunotherapy products.

Work closely with team members within Barinthus Biotherapeutics, Contract Testing Laboratories (CTL’s) and Contract Manufacturing Organisations (CMO’s) to lead development, qualification, validation, technology transfer and performance of lot release, stability and characterisation assays in accordance with Regulatory and Quality Guidelines.

Key responsibilities include, but are not limited to:

Take a lead role in the establishment, qualification, and validation of analytical assays to support Barinthus Biotherapeutic CMC (Chemistry, Manufacturing and Control) activities. Take a lead role in the establishment, development, and performance of characterisation assays for Barinthus Biotherapeutic’s products, ensuring they are scientifically appropriate. Provide technical leadership on assay transfers to Barinthus Biotherapeutics CMO’s/CTL’s. Provide technical support to CMOs/CTLs for performance of analytical assays for batch release, in-process-assessment, characterisation, and stability testing. Author and technical review of, standard operating procedures, assay qualification / development/ transfer/ validation reports and analytical methods ensuring good quality guidelines are adhered to throughout. Management (direct and/or matrix) of junior colleagues. Provide training to other staff as necessary and appropriate. Perform/manage laboratory work as required to meet department objectives. Author and review analytical sections of regulatory submissions as appropriate. Contribute to the routine running of the laboratory and maintenance of the equipment. Participate in team and other scientific meetings, presenting data and conclusions as required. Adhere to applicable policies and procedures relating to working in the laboratory.

Personal Abilities and Traits:

Be a highly organized, enthusiastic, self-motivated team player. Technically competent and capable of working independently in a laboratory. Excellent collaboration, communication and interpersonal skills. Ability to work to tight deadlines and be capable of readily adapting to changing priorities in a fast-paced environment. High-level of attention to detail. Proven ability to work and communicate effectively as part of a team and liaise with teams in other functions/organisations.

Essential Knowledge, experience and skills:

A Ph.D or equivalent experience in a life science discipline. Practical laboratory experience, ideally gained in a Biotechnology/Pharmaceutical setting Good practical experience in development and qualification/validation (as per ICH Q2) of a range of techniques such as ELISA methodologies for protein detection, dPCR, qPCR, Western blotting, AEX, RP-HPLC, Full/Empty Capsid quantification, infectious viral titration, cell based potency, etc. Practical knowledge of ICH Q2 and Q14 and assay tech transfer. Ability to write and record laboratory activities clearly and accurately. Ability to analyze and research complex issues and write factual reports. Knowledge of GMP and assay troubleshooting and root cause analysis.

Desired skills:

Understanding principles of Design of Experiments and relevant software. Line management experience Understanding of methods used in the analysis of peptides Understanding of GMP stability studies and ICH Q1 guidelines

Notice to recruiters

Barinthus Bio’s internal Talent Acquisition leads recruitment and employment for Barinthus Bio. Unsolicited resumes sent to Barinthus Bio from recruiters do not constitute any type of relationship between the recruiter and Barinthus Bio and do not obligate Barinthus Bio to pay fees should we hire from those resumes. Barinthus Bio operate a preferred list of recruitment suppliers, any and all enquiries about joining us as a supplier should be directed to Barthinus Bio’s TA Team. We ask that external recruiters and/ or agencies not contact or present candidates directly to our hiring manager or employees.

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