Altasciences
PK/ADA Scientist
Columbia, Missouri
Sponsorship not specifiedDetected 30 days ago
GCPClinical TrialsAnimal Studies
About the role
- The PK/ADA Scientist II is assigned to projects based on scientific competency and training.
- The Scientist will ensure the overall integrity/quality of assigned studies.
- The Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects.
Responsibilities
- Autonomous and proficient developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction
- For validations and sample analysis the Scientist can be assigned as Bioanalytical Principal Investigator and is the first point of contact for PM and/or clients for laboratory services and will manage and conduct method development, qualification, validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices.
- Manage project and order appropriate material, as needed
- When applicable, provide QC support on studies assigned to other team members in laboratory based on training and competencies.
- Manage as to maintain timeline and scheduling commitments
- When applicable review and provide comments and recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed.
- Support and mentor Analysts in the daily operations for completion of sample analysis and/or validation studies and the analysts work.
- Support and mentor other team members based on expertise.
Requirements
- Minimum 3 years of experience in a pre clinical/CRO
- Knowledge of regulatory agency guidelines, must understand general SOPs and have excellent knowledge of GLP regulations.
Nice to have
- Ideally College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field.
Compensation
- Annual Performance Review
Benefits
- Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
- Altasciences' Benefits Package Includes:
- Health/Dental/Vision Insurance Plans
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Referral Bonus Program
- Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
Company info
- Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies
Equal opportunity
- equal opportunity employer committed to diversity and inclusion.
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