R&D Specialist

RTA Laboratories; İzmit; On-site; TRY 600,000 - 900,000; Full time

Job summary

RTA Laboratories seeks a motivated R&D Specialist to join their Research & Development team in Gebze. You will design, execute, and document molecular biology experiments for IVD product development, from concept to regulatory transfer to production.

You will perform performance studies and prepare technical reports in English aligned with ISO 13485 standards. Required are a Master's or PhD in a life science field, hands-on molecular techniques, independent work experience, and strong English

Qualifications

• Master's or PhD in Molecular Biology, Genetics, Biotechnology, Bioengineering or related life sciences.
• Hands-on laboratory experience with molecular techniques (DNA/RNA extraction, qPCR).
• Experience planning and running experiments independently and reporting data.
• Good laboratory practice knowledge.
• Excellent written English (technical/scientific) and good spoken English.
• Familiarity with ISO 13485 and IVDR is an advantage.
• 1–2 years of R&D or laboratory experience preferred.
• Strong analytical thinking, organizational skills and attention to detail.

Responsibilities

• Design, plan and perform molecular biology experiments for development of IVD products.
• Carry out performance studies (sensitivity/LoD, specificity, cross-reactivity, precision).
• Analyze and interpret experimental data; troubleshoot assays as needed.
• Prepare experiment reports, procedures, risk analyses and other technical documentation in English per ISO 13485.
• Contribute to performance evaluation and clinical studies; compile technical files per IVDR.
• Follow literature, regulations and standards; contribute to new product ideas.
• Present results to internal teams and external audiences.

Skills

Molecular biology

qPCR

Data analysis

English proficiency

Independent work

Education

Master's or PhD in Molecular Biology/Genetics/Bioengineering

Tools

qPCR platforms

Primer design

Job description

We are seeking a motivated and detail-oriented R&D Specialist to join our Research & Development team. The successful candidate will play a key role in the design, development, execution and documentation of experiments related to molecular in vitro diagnostic (IVD) medical devices, from early product ideas through to regulatory documentation and transfer to production.

Key Responsibilities:

• Design, plan and perform molecular biology experiments for the development of IVD products (e.g., nucleic acid extraction, PCR/qPCR assay design and optimization)
• Carry out performance studies (e.g., sensitivity/LoD, specificity, cross-reactivity, precision)
• Analyze and interpret experimental data accurately, and troubleshoot assays as needed
• Prepare experiment reports, procedures, risk analyses and other technical documentation in English, in line with ISO 13485
• Contribute to performance evaluation and clinical performance studies, and compile technical files as required by IVDR (EU 2017/746)
• Follow scientific literature, competitor products, and relevant regulations and international standards
• Contribute to new product ideas
• Present results to internal teams and external audiences (e.g., conferences, exhibitions, customer demos and trainings)

Requirements:

• A Master's or PhD degree (completed or currently in progress) in Molecular Biology and Genetics, Biotechnology, Bioengineering, Biology or a related life science field
• Hands-on laboratory experience with molecular techniques (e.g., DNA/RNA extraction, qPCR); experience with primer/probe design is a plus
• Experience in planning and running experiments independently, and in reporting and analyzing data
• Knowledge of good laboratory practice
• Excellent written English (technical and scientific); good spoken English
• Familiarity with ISO 13485 and IVDR is an advantage
• 1–2 years of R&D or laboratory experience is preferred
• Strong analytical thinking, organizational skills and attention to detail, and the ability to work both independently and as part of a team

Please note: candidates holding, or currently pursuing, a Master's or PhD degree will be prioritized.

Location & Transportation:

Our R&D facility is located in Gebze/Kocaeli. Company shuttles are available from Gebze, Darıca, Çayırova and along the D100 on the Istanbul Anatolian side for an easy and convenient commute.