Group Leader, Inhalation – Onsite with PPD Client located in Stevenage
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Our onsite GMP lab teams offer PPD’s client 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 onsite with our clients, with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.
About the position
PPD’s onsite staff provides laboratory services that are designed to increase speed and precision. Our lab employees are based on client site and are dedicated to this client. They are committed to quality results and strict compliance with regulatory standards. The role of Group Leader is to provide support to our Inhalation Technology Services team with our client 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 our client, with direct supervisory responsibilities of a group of Scientists (up to 10-15).
• 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 – 4-5 years +
• 10 years + in the Pharma industry
• 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.