Bioanalyst

COMAC MEDICAL is a Full Service CRO/ SMO providing a broad network of clinical research sites in the best healthcare institutions across Central and Eastern Europe.
Currently, the Company is looking to hire:

Bioanalyst
Location: Sofia

Duties and activities:
- Strict performance/ control over bioanalytical milestones: assay development, regulated and scientific bioanalytical validation, sample analysis, reporting and technical writing.
- Collaboration with external vendors.
- Assist CFD/Project Leader with determination of project task lists related to the bioanalytical activities, as directed.
- Maintains thorough records as well as perform peer review of colleagues’ records.
- Manages analysis troubleshooting.
- Perform assigned tasks carefully and on schedule according to standard operating procedures.
- Support of the respective stakeholders in terms of bioanalytical activities.
- Writes/reviews bioanalytical components of clinical study protocols and reports.
- Prepare and organize study documentation as directed.
- Prepare or review bioanalytical reports and related documents.
- Prepare or review validation reports and related documents.
- Prepare or review method description protocols.
- Make and document scientific observations.
- Describe clearly experimental objectives and data conclusions.
- Promptly record lab meta and/ or raw data ensuring completeness and accuracy, including documentation of any deviations that occur during development, validation and analysis.
- Serve as Study Director for projects as directed.
- Serve as Benchtop Analyst as directed.
- Support Quality Group in preparation of audits related to bioanalysis, as directed
- Support Quality Group in preparation of SOPs, as directed.

The Person:
- Graduate or postgraduate degree in Chemistry, Biology or another relevant scientific field.
- At least 2 years of experience in performing bioanalysis in laboratory with the same scope of activities.
- Thorough knowledge of clinical research process, including working knowledge of all functional areas of bioanalytical activities.
- Working knowledge of current ICH/GCP guidelines, GLP principles, applicable regulations (including country specific ones), and current industry practices.
- Excellent organizational, communication (verbal and written) and interpersonal skills.
- Ability to reason independently for the purpose of assessing and recommending specific solutions in bioanalytical projects.
- Proficiency in English.
- Positive attitude and ability to interact with all levels of staff.
- Ability to work under pressure and to keep tight deadlines.
- Working knowledge of MS Office and specialized software.

The Assigned Country: Bulgaria

If you are interested in this position please send your CV and a cover letter ( to: hr@comac-medical.com) describing why your experience and skills make you a good candidate for this position.