External Contract Testing Laboratory Project Manager
Role Overview
A leading biopharmaceutical organisation is seeking an experienced scientific professional to join its External Process Development team on an initial 12-month contract.
The successful candidate will work closely with external Contract Research Organisations (CROs) and Contract Testing Laboratories (CTLs) to support analytical testing activities across a portfolio of drug development programmes.
The role will focus on managing external laboratory partnerships, coordinating analytical project delivery, and ensuring that testing activities meet required quality, compliance, cost, and timeline objectives. The successful candidate will collaborate with internal scientific, technical, quality, and supply chain stakeholders, as well as external service providers, to support the development and commercialisation of biopharmaceutical products.
Key Responsibilities
- External Supplier Relationship Management: Develop and maintain effective relationships with external laboratory partners, monitor supplier performance, establish relevant performance metrics, and identify opportunities to improve efficiency and service delivery.
- Project and Portfolio Management: Manage a portfolio of multidisciplinary projects spanning drug substance, drug product, and analytical sciences, ensuring that project activities are prioritised and delivered in line with agreed timelines, budgets, and technical requirements.
- Analytical Testing Coordination: Oversee the delivery of analytical work packages through external laboratories, including analytical method qualification, transfer and validation, product release testing, stability studies, product characterisation, and sample management.
- Cross-Functional Collaboration: Work effectively within matrixed teams, collaborating with scientific, technical, quality, regulatory, and business stakeholders to support programme objectives and maintain clear accountability for project performance.
- Quality and Compliance: Ensure that external laboratory activities meet applicable quality standards, regulatory expectations, and relevant Good Manufacturing Practice (cGMP) requirements.
- Issue Resolution and Escalation Management: Identify, investigate, and coordinate the resolution of analytical testing issues, ensuring that escalations are accurately documented, communicated promptly, and addressed through appropriate channels.
- Performance and Delivery Management: Monitor the quality, cost, and timeliness of external laboratory deliverables, proactively addressing risks and working with stakeholders to maintain programme commitments.
- Continuous Improvement: Identify opportunities to optimise project timelines, budgets, technical execution, and operational processes across the external testing portfolio.
- Supplier Assessment and Selection: Contribute to the evaluation, qualification, and selection of external laboratory service providers based on technical capability, quality standards, performance, and business requirements.
- Scientific and Technical Oversight: Apply a strong understanding of analytical development and biopharmaceutical product development to support effective decision-making and ensure successful delivery of assigned programmes.
- Strategic Portfolio Management: Support the prioritisation and ongoing management of external testing projects, balancing scientific requirements, business priorities, resource constraints, and programme milestones.
- Stakeholder Communication: Provide clear and timely updates on project progress, supplier performance, risks, and analytical issues to relevant internal and external stakeholders.
The position may require occasional domestic and international travel.
Basic Qualifications
Candidates must meet one of the following criteria:
- A Master's degree in a relevant scientific discipline, together with at least three years of scientific experience; or
- A Bachelor's degree in a relevant scientific discipline, together with at least five years of scientific experience.
Preferred Qualifications
- An advanced degree in Engineering, Science, or a related technical discipline.
- Experience in large-molecule analytical development, including analytical method development, qualification, transfer, validation, release testing, stability testing, and product characterisation.
- Experience working with external Contract Testing Laboratories (CTLs) and Contract Research Organisations (CROs), including international service providers.
- A strong understanding of cGMP requirements, regulatory and Chemistry, Manufacturing and Controls (CMC) considerations, quality systems, legal requirements, and import/export regulations.
- Knowledge of pharmaceutical and biopharmaceutical drug development, from early-stage development through to commercialisation.
- Demonstrated ability to work effectively within cross-functional and matrixed teams, with experience contributing to or leading multidisciplinary projects.
- Excellent written and verbal communication, presentation, organisational, and stakeholder management skills.
- A proactive, self-motivated approach, with the ability to navigate ambiguity, manage competing priorities, and deliver high-quality outcomes in complex environments.
- Strong business acumen, strategic thinking, and analytical problem-solving capabilities, with the ability to structure complex challenges and develop practical solutions.
- Experience in performance management, business process development, continuous improvement, and operational excellence.
- Strong quantitative and analytical skills, with the ability to interpret performance data, assess project risks, and support evidence-based decision-making.
Contract Details
- Contract duration: Initial 12 months.
- Working environment: Collaborative, cross-functional role involving internal development teams and external laboratory partners.
- Travel requirements: Occasional domestic and international travel may be required.
