Stability Coordinator

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Main Purpose Of Role

• To organise and manage all stability studies within the Analytical Services department.
• To ensure compliance with relevant Company, local and international Regulatory and Client requirements at all times.
• To ensure that stability time points and sample pulls comply with relevant procedures and Client expectations and data is reported in line with Technical Agreements, Internal procedures and client expectation.
• Responsible for leadership of the stability study management within Analytical Services Group ensuring timely co-ordination of routine stability analysis, with respect to set down and pull dates in line with business needs.
  
  

Main Responsibilities

• Technical/Analytical Services
• To lead and drive the management of stability studies within Analytical Services to achieve the required
• To maintain stability inventory and facilities.
• To generate and authorise technical documentation (inc. stability protocols and stability reports) and to routinely participate in review procedures in relation to stability testing activities. This may extend to other
• areas within the Department, as required.
• To prepare technical documentation within the Department, as required.
• To train others as required, to ensure that all members of the Team are adequately trained in the use and running of the stability management systems.
• To maintain a thorough understanding of international regulatory and ISO requirements pertinent to the role and to ensure that this information is made available to the team, with departmental procedures and the
• principles of Good Manufacturing Practice.
• To ensure that all stability study co-ordination activities including those of sub-contract facilities providing a service to the Team and co-ordination team investigations, deviations and change controls are complied
• with, subject to there being no attenuating circumstances.
• To carry out and manage projects within the Department and at international level, as required.
• Review and improve on stability management systems in line with business needs.
• To communicate effectively with other groups on site and external clients and to participate with them in problem solving activities as required.
  
  

Requirements

• GMP Skill Level 1 is essential for this role
• Minimum Degree in a Scientific Subject (preferably Chemistry or Microbiology)
• Experience within the pharmaceutical industry.
• Experience in a similar role advantageous.
  
  

Benefits

At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer:

• Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
• Relocation Package (if applicable).
• Hybrid work: ideally, 4 days in the office with flexibility.
• Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
• Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
• Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
• Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
• Staff Engagement: We value your dedication with recognition schemes and long-service awards.
• Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
• On-Site Subsidized Canteen.
• Cycle to Work Scheme.
• Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
  
  

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.