Group Leader, Analytical Development Team – Onsite with PPD Client located in Stevenage
PPD is a leading contract research organisation that works with numerous pharmaceutical companies across the world. PPD has worked with 47 of the top 50 pharmaceutical companies and over 750 biotechnology companies.
The role of Group Leader is a supervisory position to be located onsite with one of our clients within their Analytical Development Team managing the PPD Scientists that are also based on client site. Duties would include supervision, project management and technical direction to laboratory staff for project activities. Responsibilities would include overseeing direct reports daily operations to monitor quality and project timelines. The group leader would act as the responsible Project Lead and direct contact with the client on designated projects. This position involves direct supervisory responsibilities of a group of Scientists, approximately 8.
• Allocation, scheduling and supervising direct reports for project activities.
• Preparation, review or approval of study protocols, project status reports, final study reports and other project-related technical documents.
• Designing experimental study protocols and lead direct reports in technical troubleshooting for methods and instrumentation.
• 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.
• Projecting and updating project milestones for assigned project studies
• Assisting in preparation of study 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.)
• Educated to a Bachelor's Degree level in a related science field.
• Supervisory experience in the pharmaceutical, biotech or analytical contract laboratory industries of 4-5 years +
• Experience in the pharmaceutical industry 10 years +
• Experience in one or more of the following areas Stability Analysis /QC Analysis /Analytical R&D/ Method Development and Validation.
• Experience in supervisory/technical support of direct report staff.
• Full understanding of GMP requirements, GMP documentation, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.
• Knowledge and experience in a minimum of three of the following techniques: HPLC, UPLC, GC, GC-MS, Leachables analysis, Oligonucleotide Analysis, Pharmacopia Methods of analysis, Dissolution, FTIR, UV, wet chemistry
The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With a year on year growth, there is the opportunity to progress in your career with PPD. We offer a generous salary, medical insurance, pension, life insurance.