
Biotechnology Research Specialist
7 days ago
We are seeking a highly skilled Biotechnology Scientist to join our team.
The ideal candidate will possess a thorough understanding of HPLC based analysis of recombinant proteins, including RP-HPLC, SE-HPLC, and glycan analysis.
The successful candidate will be responsible for independently designing method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines, including the writing and review of protocols, transfer plans, and reports.
Responsibilities include carrying out day-to-day analytical work, working in coordination with the Cell culture and downstream teams in Biotech R&D, setting up product related test/release specifications and analytical protocols for Biotech products, and designing in-house/outsource methods for physico-chemical characterization of biological products.
The successful candidate will also be responsible for maintaining equipment logs and documentation in the lab, monitoring the stability of various products in Biotech, interpreting data, and writing reports in support of regulatory submissions.
Furthermore, they will review analytical data for in-process & stability related activities, and prepare lab-related documents, regulatory submission documents, and QC supports (SOP, STP, COA, MOA, Specification).
Key Responsibilities:
- Designing and developing analytical methods for protein characterization
- Carrying out daily laboratory tasks, such as testing and quality control
- Collaborating with cross-functional teams to ensure seamless product development
- Maintaining accurate records and documentation of laboratory procedures and results
- Preparing and submitting reports to support regulatory compliance
Required Qualifications:
- Bachelor's degree in Biological Sciences or related field
- Experience in HPLC based analysis of recombinant proteins
- Strong knowledge of ICH/USP/EP/IP guidelines
- Excellent communication and problem-solving skills
Benefits:
- Opportunity to work on cutting-edge biotechnology projects
- Collaborative and dynamic work environment
- Professional growth and development opportunities
Note:
- Only candidates with relevant experience will be considered
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