Analytical Scientist - Singapore - KINGFISHER RECRUITMENT (SINGAPORE) PTE. LTD.

KINGFISHER RECRUITMENT (SINGAPORE) PTE. LTD.

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

beBee Recruiter

Description

Key responsibilities

Establish the Singapore site inhouse mRNA analytical platform, by transferring in a full panel of

analytical methods for mRNA characterizations. Test methods employed include, but are not
limited to, capillary electrophoresis, qPCR, LC-MS, HPLC/UPLC, spectrophotometry, ELISAs, cellbased assays, etc., including high throughput versions.

Build analytical capacities to support research and development team's daily testing needs for

intermediate & final product characterization. ensuring that projects are delivered in a timely
and efficient manner.

Collaborate crossfunctionally to identify and prioritize projectbased assay development needs.

Establish analytical development strategy based on project phases and method lifecycle
management

Lead the design and execution of project specific development studies, (e.g. impurity

characterization, cell-based in vitro potency assay). Use statistical analysis tools and DoE to
perform method robustness studies and to establish relevant system suitability criteria for
methods. Qualify, document, and transfer the developed assays if project enters later
development phase.

Authorize and review method SOPs, method development, qualification and transfer

protocols and report. Support the drafting of regulatory filing documents. Oversee activities
and provide SME support for method transfers to QC/CROs.

Maintain excellent documentation of completed experiments (e.g. electronic lab notebook

and study reports).

Optimize and trend assay performance. Troubleshoot for both method and equipment issues.
Identify, qualify, and manage analytical reagents; Establish reference standard and control

materials as needed; general lab housekeeping, including equipment maintenance, inventory
of supplies, etc. to ensure smooth day-to-day operation of analytical activities.

Communicate effectively with regular verbal and formal updates to project teams and

management.

Qualifications

D. in Analytical Chemistry, Biophysics, Biochemistry, Molecular Biology, Biological
Engineering, or related discipline with at least 4 years industry or related professional analytical
experience, or a Master's degree with over 6 years' experience. Experience in process
development, and/or regulatory aspects of nucleic acid products is a plus.

Advanced handson development experience which covers most of the following analytical

methods:
ELISAs, cell-based potency assays, HPLC/UPLC, CE, qPCR, and LC-MS. Experience with
mRNA characterization is highly desired. Excellent instrument and method troubleshooting
skills.

Demonstrated capabilities to implement advance technologies. Experience using QbD principles

and tools e.g. DOE to develop analytical methods desired.

Proficiency in good documentation practices and data analysis and reporting. Strong

organizational skills, attention to accuracy and detail.

Demonstrated forward thinking skills, with the flexibility to support multiple development

programs simultaneously. The ability to work in a fast-paced dynamic environment with
changing priorities. Able to efficiently plan own time and prioritize lab work to deliver project
goals.