Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Role: Associate Group Leader

Department: Biopharmaceutical

Details: Full time, fully onsite

At 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 through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Oversee analysts and lab activities for a routine testing and stability team within the Biopharmaceutical department.
• Prepares study protocols, project status reports, final study reports and other project-related technical documentation.
• Designs experimental study and participates in technical troubleshooting.
• Provide regular support and performance management for direct reports, including tracking progress against goals, approving time sheets, and conducting regular meetings.
• Collaborate effectively with other lab leaders to build and maintain strong working relationships.
• Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation.
• Organizes, schedules and supervises laboratory resources for group's project activities and updates project status.
• Responds to client questions and needs, coordinates client communication and records meeting minutes.
• Assists group leaders in their responsibilities.
• Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years) or equivalent and relevant combination of education, training, & experience.
• 1+ year of leadership responsibility

• Knowledge of biopharmaceutical testing or HPLC preferred
• Demonstrated proficiency on technical operating systems
• Proven leadership skills
• Ability to train and mentor junior staff
• Demonstrated ability to be project solution driven
• Good written and oral communication skills as well as presentation skills
• Can independently perform root cause analysis for method investigations
• Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
• Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
• Ability to independently optimize analytical methods
• Project and time leadership skills

• 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.