Work Schedule
Other

Environmental Conditions
Office

Job Description

Sr Group Leader - Pharma

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 tiered organizational structure comprised of supervisors and analysts
• Allocation, scheduling and managing laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
• Review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
• Reviewing data for technical quality and compliance to protocols, methods and SOPs. Approve laboratory investigations, deviations, QA facility and data audits. Leads client and regulatory authority audits.
• Responding to client questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.
• Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with clients on timelines and budgets.
• Preparing and implementing SOPs and company operational policies Ensuring adherence and making recommendations for quality system improvements.
• Collaborates with business development as technical representative for client visits/discussions. Identifies business opportunities through client interactions, within community, at conferences/workshops. Participates in technical sales and marketing.
• Participates in bi-annual SOP review and change management. Ownership of changes needed to comply with SOPs.
• Regularly communicates to staff quality related issues and items for staff development, and implements quality improvements.

• Educated to a bachelor's degree level in a relevant area, ie chemistry, pharma science, etc

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.
• 2+ years of management 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, including mentoring/coaching
• Ability to cultivate a collaborative work environment with a team and across business units; including the ability to identify and implement common efficiencies across the teams/units, as well as projects/programs
• 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, such as HPLC, UPLC, KF, UV-Vis etc.
• Understanding of basic financial terms and definitions as it applies to the business
• Ability to independently develop project proposals/plans. Utilizes expertise of others to develop programs to meet client needs.

• 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 15-20 pounds.
• Able to work in non-traditional work environments.
• Frequently interacts with others, relates sensitive information to diverse groups
• 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.