Work Schedule
Other

Environmental Conditions
Office

Job Description

At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.

• Management of a team of analysts
• 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, 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 for quality system improvements.

• Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
• 1+ year of leadership responsibility

• 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, EMA and FDA guidance's.
• Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.