Scientist I/ii or Sr. Scientist
il y a 1 semaine
**Purpose**
Amador Bioscience (AmadorBio) is a Translational & Clinical Pharmacology CRO providing global-standard services in quantitative clinical pharmacology, GLP/GCLP bioanalysis, clinical research, and regulatory filing to leading biopharmaceutical companies. Our clients include multinational pharmaceuticals and mid
- and small-size biotech companies.
**Role and Responsibilities**
- Develop, validate, conduct, and troubleshoot bioanalytical methods for biological sample testing and data reporting.
- Present/interpret data internally and/or externally as needed.
- Participate in interactions with clients and ensure overall customer satisfaction.
- Interacts with QA to ensure all audit findings are addressed in a timely fashion.
- Author and/or review key regulatory documents, laboratory data, and technical reports.
- Assist with the oversight of the laboratory and mentor junior staff.
- Assist in establishing and improving all policies, procedures and required SOP documentation.
- Understand and adhere to corporate standards regarding code of conduct, safety, and GLP/GCP/GDP compliance.
- Ensure and reviews lab maintenance activities and maintains a clean and safe lab environment
- Develop, write, and review protocols and SOPs.
- Participate in regulatory compliance activities
- Perform all other related duties as assigned
**Qualifications and Education Requirements**
- Ph.D., Master’s, or Bachelor’s degree in biology, immunology, chemistry, pharmacology, or other related scientific fields required.
- Requires a minimum 0-9 years of relevant experience in a CRO or drug-development environment.
- Ability to work independently and have good attention to details.
- Good knowledge of regulated bioanalysis. GLP/GCLP experience preferred.
- Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and clients.
- Must be goal-oriented, quality-conscientious, and client-focused.
- Effective written and verbal communication skills.
- Experienced with Ligand Binding Assay (ELISA, MSD) and/or Cell-Based Assay method development and validation for PK, ADA, and/or biomarker analysis.
**Preferred Skills**
- Proficient in MS Office
- Watson LIMS
- Strong knowledge of GLP/GCLP regulations
**Benefits**:
- Company computer
- Eco vouchers
- Hospitalization insurance
- Professional development assistance
- Retirement plan
Schedule:
- Monday to Friday
Work Location: Hybrid remote in 3500 Hasselt België
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