Stability Lead

Argenta; Scotland; Vor Ort; GBP 65.000 - 90.000; Vollzeit

Zusammenfassung

Argenta is seeking a Stability Lead to head the Stability function within Quality Control. You will design and manage stability studies, ensure proper storage conditions, and oversee data, documentation and reporting to GMP standards.

The role requires leadership in a laboratory setting, strong GMP knowledge, and experience with stability programmes, data review and cross-functional collaboration. A proactive, quality-driven mindset is essential.

Qualifikationen

• HNC or degree in a scientific discipline such as Chemistry, Pharmacy or Biology.
• Strong GMP knowledge and familiarity with global pharmaceutical regulations including stability guidance (ICH Q1).
• Demonstrated leadership in a laboratory/technical setting with team development.
• Experience with stability programmes: protocol design, storage conditions, and sample pulls.
• Ability to review data, guide analysts and communicate results clearly.
• Experience with documentation: SOPs, protocols, reports, and technical writing.

Aufgaben

• Lead the stability function within Quality Control to ensure studies are designed and managed correctly.
• Oversee stability storage, chamber management, condition monitoring and excursions.
• Coordinate stability pulls and ensure traceability, receipt, and inventory control.
• Ensure timely planning, scheduling, and 12-week visibility with QC teams.
• Review, approve and trend stability data and reports.
• Close CAPAs, incidents, change controls and audits related to stability.

Kenntnisse

Leadership

Quality mindset

GMP knowledge

Regulatory awareness

Data integrity

Project planning

Mentoring

Communication

Analytical skills

Problem solving

Ausbildung

HNC or Degree in relevant scientific discipline

Tools

Chromatography systems/software

Office tools (Excel)

Jobbeschreibung

About Argenta

At Argenta, we’re more than a company - we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions cover every stage of the process, from molecule to market.

We are in a unique position: the world’s only combined contract research and contract development and manufacturing organisation (CRO/CDMO) dedicated solely to animal health.

We are ambitious, growing, and building a One Team culture, grounded in our values:

• We are team players.
• We are doers.
• We are customer-centric.
• We are innovators.

As a global company, we value diversity and the richness it brings - across locations, career stages, backgrounds, and experiences.

When every person brings their best 'paw' forward, we make animals' lives better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.

Team players who want to do great work and find innovative ways to make animals’ lives better through our customer-centric efforts should apply.

About The Role

The Stability Lead will be responsible to lead the effective delivery of the Stability function within Quality Control, ensuring stability studies are designed, scheduled and managed correctly, samples are stored and organised under the right conditions, and stability data, documentation and reporting are completed accurately, on time and in compliance with GMP, regulatory requirements and company procedures.

Experience

• Pharmaceutical, laboratory or related environment awareness

Key Responsibilities

• Champion Health and Safety by adhering to policies, reporting incidents, identifying risks and promoting a strong safety culture.
• Support the Head of QC in cultivating a culture of quality, compliance and continuous improvement (GMP, PDCA, Data Integrity, Housekeeping), and drive adherence to SOPs, GMP standards and company policies.
• Provide leadership and technical guidance to the stability team, including training, coaching, mentorship and encouraging adaptability.
• Author, review and approve stability protocols and study designs in line with client requirements, relevant regulatory guidance (e.g. ICH Q1) and company procedures.
• Oversee stability storage and chamber management, including condition monitoring, excursion handling, and qualification and maintenance, so that samples are always held under the correct conditions.
• Organise and coordinate stability pulls, and ensure effective sample management and documentation, including receipt, inventory and traceability.
• Maintain accurate planning and scheduling, including 12-week visibility, in coordination with the QC teams who perform the testing, and ensure timely completion of PQRs (Product Quality Reviews).
• Ensure stability data is reviewed, approved and trended on time, and that results and reports are accurate and complete.
• Oversee the closure of CAPAs, incidents, change controls, audits, SOPs and method updates relating to stability, and manage stability laboratory systems and processes to maintain efficiency and regulatory compliance.

Qualifications

• HNC or Degree in relevant scientific Discipline (e.g. Chemistry/Pharmacy/Biology)
• Strong knowledge of GMP and global pharmaceutical regulations, including stability guidance (e.g. ICH Q1).
• Demonstrated leadership experience in a laboratory or technical environment, including developing and motivating a team.
• Practical experience of stability programmes, including protocol and study design, storage condition and chamber management, and pull scheduling.
• Strong technical understanding of chemistry, laboratory techniques and chromatography systems/software, sufficient to review data and guide analysts.
• Working knowledge of analytical method development and transfer, and proficiency in technical documentation (e.g. SOPs, protocols, reports).
• Excellent communication, conflict resolution and resource management skills, with confidence in client-facing situations.
• Strong planning and organisational skills.
• Strong Microsoft Office skills, particularly in Excel, and confidence using laboratory and business IT systems.
• A collaborative, solution-oriented mindset with a focus on continuous improvement.
• Ability to mentor, multitask and adapt to evolving priorities.
• Accountability, drive and alignment with company values.