Research and Development Specialist

JOB TITLE: 

Research and Development Specialist

DEPARTMENT: 

Central Lab Services

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

PURPOSE: 

The Research and Development (R&D) Specialist for Central Lab Services, with a specific focus on Bioanalytical Primary and Secondary Endpoint Validation Support, plays a pivotal role in advancing laboratory processes, methodologies, and technologies within a central laboratory setting. This position involves designing, implementing, and overseeing research projects aimed at enhancing the efficiency, accuracy, and quality of laboratory services, with an emphasis on bioanalytical method validation. The specialist will collaborate with cross-functional teams, manage projects, and contribute to the continuous improvement of laboratory operations.

DUTIES / RESPONSIBILITIES:

Study Project Management:

• Support study setup, method development, method validation, and study support for clinical trial clients
• Develop and execute research projects to improve existing laboratory processes and introduce new technologies.
• Coordinate project timelines, milestones, and deliverables to ensure timely completion.

Technology Integration:

• Evaluate and integrate new technologies and instrumentation to enhance laboratory capabilities.
• Collaborate with vendors and internal stakeholders to assess, acquire, and implement new equipment.

Quality Assurance and Control:

• Implement and maintain quality control measures to ensure accuracy and reliability of laboratory results.
• Develop and update standard operating procedures (SOPs) in line with industry standards, e.g., FDA, CAP/CLIA.

Bioanalytical Method Development:

• Collaborate with central lab and bioanalytical scientists to develop and optimize methods for biomarker and drug quantification.
• Ensure bioanalytical methods meet sensitivity, selectivity, precision, and accuracy requirement as well as client requirements.

Endpoint Validation Planning and Execution:

• Develop validation plans for primary and secondary endpoints in bioanalytical studies.
• Oversee the execution of bioanalytical method validation studies, ensuring adherence to timelines and acceptance criteria.

Regulatory Compliance:

• Stay current with regulatory guidelines related to bioanalytical method validation.
• Ensure validation activities adhere to relevant regulations for the project, e.g., GLP, CAP/CLIA.

Collaboration with Cross-Functional Teams:

• Work closely with bioanalytical scientists, Central Lab technologists, and data managers to align validation activities with study objectives.
• Provide input on study design to support robust validation.

Documentation and Reporting for Regulatory Submissions:

• Prepare and review documentation for regulatory submissions, including validation reports and sample analysis reports.
• Participate in regulatory inspections and audits related to bioanalytical validation.

Troubleshooting and Issue Resolution:

• Identify and address challenges and deviations during the validation process.
• Collaborate with laboratory personnel to troubleshoot and resolve issues promptly.

Continuous Improvement:

• Contribute to the continuous improvement of bioanalytical processes and methodologies.
• Implement corrective and preventive actions based on validation findings and lessons learned.

Training and Knowledge Transfer:

• Provide training to laboratory staff on bioanalytical validation procedures and best practices.
• Facilitate knowledge transfer within the team to enhance overall expertise.

EDUCATION/ EXPERIENCE REQUIREMENTS:

• Bachelor's, Master's, or Ph.D. degree in a relevant field (e.g., Immunology, Biochemistry, Clinical Laboratory Science).
• Prior experience in a clinical laboratory or R&D laboratory setting.
• Strong understanding of bioanalytical techniques, diagnostic assays, and laboratory instrumentation.
• Proficiency in data analysis and statistical software.
• Excellent problem-solving skills and attention to detail.
• Effective written and verbal communication skills.
• Ability to work both independently and collaboratively within a multidisciplinary team.
• Familiarity with regulatory and accreditation standards for clinical laboratories is a plus.
• Adherence to safety protocols and a commitment to maintaining a safe laboratory environment.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.