Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Scientist, Biomarker Analysis
As a Scientist in Biomarker Analysis, you will be a key contributor to our bioanalytical team. Your role involves method development, validation, and sample analysis for ligand binding assays. You'll work closely with the supervisor to ensure accurate and efficient execution of bioanalytical processes. If you're passionate about advancing bioanalysis research and have a strong foundation in bioanalysis, this role is for you.
What you will do
Review scientific literature to understand existing methods for detecting and quantifying biomarkers. Explore studies related to biomarker concentrations and their relevance in various diseases.
Formulate a comprehensive strategy for biomarker testing across different platforms. Consider using techniques like MSD (Meso Scale Discovery) and PCR (Polymerase Chain Reaction). Explore various methodologies within these platforms, such as ligand binding assays and PCR-based assays.
Plan the actual biomarker tests, defining their purpose, scope, and objectives. Develop robust methods for biomarker detection, considering factors like sample preparation, assay conditions, and detection sensitivity. Decide on parameters for method validation, including precision, accuracy, linearity, and specificity. Develop validation plans specifying how you'll assess assay performance.
Create detailed analytical test method that outline step-by-step procedures for biomarker testing which insures consistency and reproducibility.
Perform method development, validation, and sample analysis lab work.
Draft standard operating procedures (SOPs), analytical methods, validation plans, and validation reports.
Analyze data and troubleshoot any issues, then create a plan for optimizing the method.
Perform equipment maintenance and operation: Ensure proper functioning, calibration, and maintenance such as freezers and fridges, plate shakers and plate readers.
Perform good documentation: thoroughly document all procedures, including steps, reagents, and instrument settings. Maintain clear and organized records for traceability and audit purposes.
Adhere to Standard Operating Procedures (SOPs) for all laboratory procedures, ensuring consistency and compliance. Document deviations and corrective actions as needed.
Properly handle and store biological samples in freezers and maintain accurate records of sample locations and conditions.
Prepare stocks, standards, quality controls, reagents and buffers required for ligand binding assays and other bioanalytical assays. Follow precise protocols to ensure consistency and reliability. Perform mathematic calculations.
Apply GCLP principles to maintain high-quality data and documentation. Ensure compliance with relevant regulations and guidelines.
What you will bring to the role
Proficient in MSD, ELISA, and PCR is a plus.
Experienced in LIM system is a plus.
Strong analytical skills and attention to detail.
Proficiency in general laboratory practices and techniques.
Ability to work independently and as part of a team.
Ability to read, execute, and understand complicated and detailed instruction and technical literature to plan, perform, and direct laboratory activities.
Must be able to work well with a variety of laboratory personnel.
Strong written and oral communication skills
Basic computer knowledge
Your experience
Education: minimal request: bachelor's degree in a scientific discipline (Immunology, molecular biology, biochemistry, or related field). Master's degree and Ph.D. are plus.
Experience: minimal request: bachelor's degree with a minimum of 2 years of direct laboratory experience. Master's degree with 1 year of direct laboratory experience.
Why Worldwide
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.