Job Purpose:

Provide technical expertise and project manage a range of bioanalytical activities on behalf of A4P’s contracted clients. This includes the oversight of outsourced bioanalysis at contract research organisations for clinical and pre-clinical drug development.

Job role:

• Oversight and management of method development, validation and sample analysis studies at contracted CROs.
• Provide technical input in the application and operation of quantitative bioanalytical techniques.
• Provide technical and regulatory expertise on bioanalytical strategies during client meetings and ensure regular updates on progress of outsourced activities to sponsor.
• Interact effectively with client’s stakeholders. This will include but not be limited to outsourcing experts, data managers, pharmacokinetic and pharmacology experts, procurement and/or bioanalytical sample managers.
• Source, select and engage with appropriate bioanalytical CROs for clients’ outsourced activities.
• Review bioanalytical data generated by CROs.
• Review draft validation and bioanalytical analysis plans, reports and study documents.
• Ensure effective communication and management strategies with contracted CROs.
• Monitor CRO’s activity and KPIs as required by clients.
• Oversight of biosample operations, support to central lab set up, kit provision to sites and sample lifecycle.
• Contribute to the development of A4P and LabConnect products and services.

Job Location:

The role can be undertaken remotely or from the A4P offices at Innovation House, Discovery Park, Sandwich, UK. For a home-based employee, travel on a needs-to basis to the A4P offices will be required.

Additionally, the role may involve travel to client’s or vendor’s sites, as requested by A4P’s client.

Required Experience:

• Degree / master's level equivalent in a biochemistry / biological science or similar discipline with a minimum of 10 years relevant pharmaceutical research and development experience in regulated bioanalysis.
• Extensive knowledge and experience in bioanalysis within regulatory environments (GLP/ GCP) to include PK / PD, biomarker and immunogenicity analysis.

• Knowledge of ligand binding assays associated analytical platforms for example ELISA, Gyrolab, MSD etc.

• Comprehensive knowledge in design and operational execution of clinical and pre-clinical studies, toxicokinetic and pharmacokinetic analysis.
• Significant understanding of the research activities within a drug development organisation.
• Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies.
• Experience in the pharma or CRO industry supporting regulated bioanalysis.
• Knowledge of the latest regulatory standards required for GXP studies including international guidance’s published by regulatory agencies.

Desirable experience:

• Experience in the analysis of complex modalities including ADC’s, multi-domain molecules, Fab constructs etc.
• Experience of PCR and/or Flow Cytometry to support drug development.
• Knowledge of EU IVDR regulations.
• Previous experience managing contract research organisations.
• Experience with change and quality management.
• Experience of input to regulatory submissions.

Personal Characteristics:

• Engaging, enthusiastic, self-motivated, confident, solution orientated, self-assured and a team player. Willing to interact with both large global and emergent SME start-up organisations.
• Demonstrable ability to prioritize activities with strong attention to detail and effectively multi-task across deliverables focused to client needs.
• Excellent communication skills in both written and oral areas. Strong presenting skills. Keen to learn and accept and give feedback constructively.
• Gain client trust and confidence in A4P abilities to deliver clients objectives and quality requirements.
• Willingness and availability to travel and work at client’s site(s) for short periods of time.
• Willingness and availability to travel and/or work at A4P’s offices in Sandwich, Kent on regular (frequency negotiable) basis for duration of employment if home office based.
• Ability to develop effective relationships with external service partners.
• Full driving license may be advantageous though not essential.

Salary and Benefits:

Salary negotiable with reimbursable travel expenses. A4P operate a discretionary rewards and recognition scheme for performance and deliverable activities. A4P offer 25 days annual paid leave (excluding public holidays).

Hours of Work:

This position is a full-time role based on 37.5 hrs. per week, excluding lunch & holidays with an initial 3-month probationary period. A4P operates a degree of informal flexibility with regards to working hours attendance.

Read more below and get ready for your next great employment adventure!