Senior Group Leader - Cell Lab

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job 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.  

R eview 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.    A pprove 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:

Min. Degree level education in Relevant scientific field ( incl.   Life science ,   Biochemistry,   immunology   or cell biology )  

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+   year s   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.