About CTS

Choosing the right partner for analytical and biosafety testing is crucial in the race for regulatory approval. Our BioReliance ® contract testing services deliver robust, risk-mitigating solutions backed by deep technical and regulatory expertise to help bring life-changing medicines to market.

The Lab Scientist at BioReliance Contract Testing Services performs a broad range of routine GMP-compliant lab tasks to support testing operations. This role includes conducting essential assays for product characterization and lot release, maintaining lab organization, preparing reagents, managing stock, and ensuring equipment maintenance. The Lab Scientist also trains and mentors junior staff, assumes responsible scientist duties for routine GMP studies, leads root-cause investigations, and provides scientific and technical support for laboratory studies.

Key Responsibilities

• Act as Responsible Scientist for routine GMP assays, ensuring proper conduct of studies.
• Collaborate with the Lab Manager or Senior Scientist to develop testing schedules for laboratory personnel.
• Ensure timely completion of trending spreadsheets and study documentation in accordance with SOPs.
• Lead and drive timely closure of deviations and CAPA (Corrective and Preventive Action) records.
• Initiate and advance Change Controls for the introduction of new services, testing methods, and assay validations.
• Adhere to SOPs and regulatory requirements to ensure studies are completed on time and accurately recorded, meeting scientific and GMP standards.
• Author and maintain laboratory protocols, SOPs, and workbooks; initiate Change Controls for new services.
• Train and mentor junior laboratory personnel.
• Participate in internal Quality Audits and regulatory audits as required.

Who you are

• Bachelor’s degree or higher in a life sciences discipline (e.g., Biology, Chemistry, Microbiology, Biotechnology) or equivalent experience.
• Experience working in a GMP-regulated laboratory.
• Strong understanding of lab processes
• Proficiency with study trending, data management, and SOP authoring
• Excellent documentation, communication, and mentoring skills.
• Familiarity with regulatory expectations (e.g., ICH, FDA, EMA) is a plus.
• Ability to work collaboratively in a cross-functional team and manage multiple priorities.