Bioanalytical Project Manager - Large Molecule Bioanalysis

Bioanalytical Project Manager - Large Molecule Bioanalysis

Wednesday, February 19, 2025

Overview

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

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 including 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.
• 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!

We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.

We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.

It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.