Study Lead, Biopharma

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

As a Study Lead within our Biopharma laboratory, you will manage multiple routine projects across areas such as release, stability and quality control testing. You will act as a key point of contact for clients and internal stakeholders, ensuring studies are delivered accurately, on time and in accordance with GMP, SOPs, regulatory requirements and client expectations.

The role combines scientific knowledge, project coordination, data review, client communication and technical leadership, while providing guidance and mentoring to laboratory teams.

Key responsibilities

• Manage multiple routine studies, coordinating project timelines, deliverables and priorities.
• Act as a key contact for clients and internal stakeholders, providing project updates and communicating technical findings.
• Review and evaluate analytical data, identifying trends, outliers and potential issues.
• Prepare and review study protocols, scientific reports, project updates and quality records.
• Oversee routine testing and troubleshooting using established analytical methods and instrumentation.
• Ensure study data and documentation meet GMP, data integrity, SOP and regulatory requirements.
• Identify risks to project timelines, data quality and deliverables and escalate appropriately.
• Support investigations, risk assessments and technical problem-solving, involving SMEs where required.
• Provide technical guidance, mentoring and training to laboratory staff.
• Support continuous improvement and implementation of process improvements.
• Maintain audit-ready documentation and support client audits and site visits.

Education & Experience

• Bachelor's degree or equivalent relevant academic/vocational qualification.
• Approximately 5+ years of relevant experience, or an equivalent combination of education, training and directly related experience.
• Experience within an analytical laboratory environment, ideally supporting routine testing, release, stability and/or quality control activities.

What we're looking for

• Strong knowledge of routine analytical testing and relevant laboratory instrumentation.
• Working knowledge of GMP requirements and data integrity principles.
• Experience reviewing and interpreting analytical data.
• Strong organisational and project-management skills, with the ability to manage competing deadlines.
• Strong technical writing and communication skills.
• Ability to troubleshoot routine technical issues and identify appropriate solutions.
• Confidence communicating with clients and cross-functional stakeholders.
• Ability to train, coach and mentor junior laboratory colleagues.
• Strong attention to detail and a quality-focused mindset.