Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Join us as an Senior Group Leader in our Laboratory Services Team!
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.
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
As a Senior Group Leader, your role will be to oversee the operations of clinical laboratory testing, ensure the accuracy and reliability of results, manage and mentor lab staff, and uphold the highest standards of quality and compliance in all laboratory practices.
What You’ll Do:
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.
Education and Experience:
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
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Experience in developing cellular and immunologically based assays
Experience in Cell & Gene therapy is ideal
Proven leadership skills
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
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
Ability to independently optimize analytical methods
Project and time management skills
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthrough.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
A clinical research organization providing drug development services.