About PPD
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 14,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.
Our Athlone GMP laboratory offers fully integrated solutions for product development and analytical development, including analytical testing services in method development and secondary packaging, labelling and storage. Our highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.
About the Associate Group Leader position
PPD provides laboratory services that are designed to increase speed and precision. Our lab employees are committed to quality results and strict compliance with regulatory standards. The role of Associate Group Leader is to provide support to our Inhalation Technology Services department by providing management and direction to laboratory staff and resources for project activities and needs, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs. You will have ownership to ensure responsiveness to the client and overall client satisfaction. This position is lab based, with direct supervisory responsibilities of a small group of Scientists, approximately 4.
Key responsibilities
• Allocation, scheduling and managing laboratory resources for group’s project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
• Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
• Designing experimental study and participates in technical troubleshooting.
• Reviewing data for technical quality and compliance to protocols, methods and SOPs. Review and approve laboratory investigations, deviations, QA facility and data audits. Assists in client and regulatory authority audits.
• Responding to client questions and needs; leads client technical meetings.
• Assisting in preparation of proposals, project definition and pricing.
• Coordinating and prioritizing project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.)
• Assisting senior group leaders and/or managers in their responsibilities.
• Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations to quality system improvements.
Skills and experience
• Educated to a Bachelor’s Degree level in a relevant area, ie chemistry.
• Management experience in the pharmaceutical, biotech or analytical contract laboratory industries.
• Stability/QC/analytical R&D/project and program management.
• Direct supervision of technical staff.
• Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMEA and FDA guidance’s.
• Knowledge and experience with inhalation products such as Pressurized Metered Dose Inhalers, (pMDI), Dry Powder Inhalers (DPI), Aqueous Nasal Sprays, Nebulizers and Nebulizer solutions.
A distinct PPD culture
Founded upon principles of excellence and innovation, PPD shares our clients’ passion for delivering life-changing therapies to help people live healthier lives. We are committed to bringing scientific and clinical expertise, quality and speed to every drug discovery and development program to help deliver safe, effective products to the market.
To apply please visit the careers pages on our website at www.ppdi.com/Careers.
We also have other positions available at different levels.
