Bioanalyst

Great job opportunity for a BIOANALYST for one of the most reputable, full-service providers of CRO and SMO.
Established in 1997, with locations in Central & Eastern Europe and over 300 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.

Currently we are looking for a professional to join our awesome team of exceptional professionals and performers.
Location: Sofia

What is expected to be done?
- Monitor and control of bioanalytical milestones: assay development, regulated and scientific bioanalytical validation, sample analysis, reporting and technical writing
- Maintains thorough records as well as perform peer review of colleagues’ records
- Record lab meta and raw data accurately
- Describe clearly experimental objectives and data conclusions
- Writes/reviews bioanalytical components of clinical study protocols and reports
- Prepare and organize study documentation
- Perform assigned tasks carefully and on schedule according to standard operating procedures
- Review and validate bioanalytical reports and related documents
- Develop and review method description protocols
- Manages analysis troubleshooting
- Act as a Study Director for projects
- Support Quality Group in preparation of SOPs and audits
- Support of the respective stakeholders in terms of bioanalytical activities.
- Assist CFD/Project Leader with determination of project task lists related to the bioanalytical activities
- Collaboration with external vendors

What is required for the role?
- 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

Why to join Comac Medical?
- Great team of knowledgeable, high-achieving and experienced professionals
- International and diverse work atmosphere
- Challenging projects in a different therapeutical area as well as in early phases
- Opportunity to enrich professional skills and progress in career development
- Competitive remuneration
- Additional health insurance and food vouchers
- Professional trainings
- Labour contract with Comac Medical

Core strengths of Comac Medical
- Proven track record for quality and delivery
- Established and trusted relationships with KOLs
- Motivated, capable and dedicated team
- Global full-service capabilities

If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English.
Apply here: https://www.jobs.bg/job/5936196