Senior Study Lead - GMP Labs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting

Job Description

Senior Study Lead – GMP Labs

GoCo Health Innovation City, Gothenburg, Sweden 

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.  

Location/Division Specific Information  

Our PPD® Laboratory Services team, part of Thermo Fisher Scientific, has a direct impact on improving patient health through the expertise of our scientists and industry-leading laboratory professionals. As the world leader in serving science, we are committed to delivering high-quality analytical services and innovative solutions that support the development and manufacture of life-changing medicines. 

As part of the continued expansion of our GMP laboratory services, we are establishing GMP analytical testing capabilities at GoCo Health Innovation City in Gothenburg, Sweden. Building on the expertise and capabilities of our established GMP laboratories in Athlone, Ireland, this new facility will provide high-quality GMP analytical testing services for small molecule pharmaceuticals, supporting pharmaceutical and biotechnology customers throughout the drug development and manufacturing lifecycle. This is an exciting opportunity to join a growing global laboratory network, contribute to the establishment of a new facility, and play a key role in delivering trusted scientific solutions that help bring medicines to patients worldwide. 

 

Discover Impactful Work:  

The Senior Study Lead will play a pivotal role in the success of our new GMP analytical testing laboratory at GoCo Health Innovation City. You will lead complex and large-scale routine testing programmes, including release, stability and quality control studies, ensuring scientific excellence, GMP compliance and high-quality delivery. As a key contact for clients and internal stakeholders, you will guide study execution, resolve technical and quality challenges, and mentor colleagues while helping to establish a culture of quality and continuous improvement.

A day in the Life:  

• Lead and coordinate multiple complex routine analytical testing projects, developing robust study plans and delivering against client expectations, timelines and quality standards. 

• Draft, review and approve technical documentation, including protocols, reports, data reviews and quality records, ensuring accuracy and data integrity. 

• Oversee investigations, deviations and risk-based assessments, making scientifically sound, compliant decisions and supporting effective CAPAs. 

• Act as a key technical contact for clients, lead technical discussions and site visits, and communicate project progress, milestones and emerging risks. 

• Drive audit and inspection readiness, support audits and address observations through corrective actions and process improvements. 

• Evaluate data trends and technical KPIs, identify risks and opportunities, and improve laboratory processes and project efficiency. 

• Collaborate with Quality Assurance, scientific subject matter experts and cross-functional teams; contribute to proposals, contract reviews and resource planning. 

• Coach and mentor Study Leads and laboratory colleagues in technical problem-solving, documentation, GMP compliance and audit readiness. 

Keys to Success:   

Education/Experience 

• Bachelor’s degree or equivalent relevant academic or vocational qualification. 

• Relevant experience comparable to 8+ years, or an equivalent combination of education, training and experience. Experience must be within GMP lab setting in analytical testing using techniques such as HPLC, UPLC, dissolution testing, Karl Fischer titration and FTIR. 

Knowledge, Skills, Abilities  

• Familiarity with ICH guidelines, Phase 3 clinical studies and clinical stability studies. 

• Experience with a range of analytical instrumentation and techniques, including HPLC, UPLC, dissolution testing, Karl Fischer titration and FTIR. 

• Advanced knowledge of routine analytical testing, laboratory instrumentation, established methods and laboratory systems. 

• Strong working knowledge of GMP and applicable regulatory expectations, including FDA guidelines, quality systems and risk mitigation. 

• Experience interpreting complex analytical data, evaluating trends and outliers, and leading investigations, root cause analysis and CAPAs. 

• Proven ability to manage multiple complex projects, prioritize competing demands and influence outcomes across cross-functional teams. 

• Excellent technical writing, client communication and stakeholder management skills, including preparation and review of protocols, reports and quality records. 

• Experience using LIMS, laboratory data systems and Microsoft Office applications; functional Power BI skills are beneficial. 

• Demonstrated mentoring, coaching and continuous improvement skills, with strong attention to detail, data integrity and ethical scientific practice. 

Benefits 

We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! 

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.   

Apply today! http://jobs.thermofisher.com  

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.  

 

We welcome and encourage applicants from outside of Sweden.  We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services.  All other relocation costs are at the expense of the applicant.