Analytical Development Manager (Senior Scientist)
This job post is currently not available.
Esco Lifesciences Group, is Singapore’s most globalized life
sciences company, with annual revenues close to SGD 200M and global operations
in over 20 countries across North America, Europe and Asia.
Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and
was first introduced in 2017.
At Esco Aster Pte Ltd, we are a contract development and
manufacturing organization founded and deeply rooted by scientists enabling
fellow scientists to translate their bench work into commercially available
products and services at affordable prices.
The work we do creates a remarkable and lasting impact on our
world. Join us as we redefine healthcare for the current and future generations
to come.
Esco Aster.
One World. One Health.
Physical/Mental Requirements/Work Environment
- Ability to read, analyze and interpret scientific data and publications.
- Ability to author or review protocols, technical reports and technology transfer documents.
- Ability to author or review standard operating procedures and other related documents.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to focus.
- Repetitive motions due to certain laboratory techniques.
- Ability to adapt and keep up with rapid changes in a fluid and dynamic environment as this is a rapidly evolving space.
You will be part of Esco Aster’s Analytical Development team and contribute to the company’s CDMO mission and objectives. You will carry out laboratory operations directed towards the development and application of analytical methods for testing, release and characterization of biological products in support of drug substance and product manufacturing. You will also work with internal and external stakeholders in the establishment and technology transfer of analytical methods such as assay qualification, validation activities and product technology transfer. Your work will require close collaboration with a multi-disciplinary team of employees and external consultants and contractors for the establishment and technology transfer of analytical methods.
Primary work location: Ayer Rajah, Singapore.
- To assist in various laboratory operations in the development and application of analytical methods for biologics including but not limited to antibodies, virus, recombinant proteins, cell therapy, gene therapy, nucleic acid therapeutics, bacterial and/or viral vaccines and extracellular vesicles/exosomes.
- To conduct experimental procedures to establish, optimize and qualify analytical methods for in-process control samples and for product release.
- To participate in new product technology transfer, and lead assay qualification and validation activities.
- To support the technology transfer of analytical methods to downstream teams, such as QC department or applicable operating department, including provision of necessary training.
- To prepare high-quality technical protocols, reports, summaries, and quantitative analysis, for dissemination to project teams, and for regulatory agency submissions.
- To interface with regulatory and testing organizations to achieve projects deliverables within the specified timeline.
- To perform analysis of experimental data using statistical approaches.
- To work collaboratively with other groups to ensure Analytical Development activities are fully supported and aligned with other functional groups such as Process Development, Drug Product Development and Quality Assurance.
- To provide expertise to support function scientists, third parties, and other functions, to achieve the project goals and priorities.
- To troubleshoot, propose and implement resolutions to technical problems/issues.
- To write and maintain accurate, complete, and timely data in laboratory notebooks and experimental records.
- To develop new related analytical methods or improve current methods.
- To support Sales, Business Development, Product Specialists and associated departments as subject matter expert.
- To provide expertise and support other departments to achieve project milestones.
- To exercise scientific creativity and independent thought in research & process development.
- To perform tasks in accordance with applicable regulations and site safety requirements.
- To undertake other tasks as assigned based on project needs.
- PhD with 2-4 years of experience or a Masters/Bachelor degree with 4-8 years of experience in Biochemistry, Immunology, Molecular Biology or similar discipline.
- Experience with development of molecular assays for biological/vaccine products.
- Possess strong practical knowledge of molecular biology techniques such as RT-PCR, qPCR and/or NGS. Strong experience with flow cytometry is a plus.
- Familiarity with biological assays (Western blotting, SDS gels, PCRs, ELISA, protein assays etc) and analytical techniques (UV/IR/Raman Spectroscopy, HPLC, LCMS) is desired. Strong experience with flow cytometry is a plus.
- Experience in a GMP quality control environment preferred.
- Experience in analytical and QC testing of biologics is desirable.
- Previous experience with statistics and assay variability analysis, as applied in an industrial biopharmaceutical environment will be a distinct advantage.
- Experience with Good Laboratory Practices (GLP) will be an advantage.
- Ability to plan and perform experiments in an interdisciplinary environment independently and efficiently.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Excellent written and verbal communication skills.
- Strong team player, develop positive relationship with a strong set of interpersonal skills.
- During the start-up phase of the team/facility, be willing to take on expanded role to set up workflow/processes as needed.
Apply now by submitting a Cover Letter and CV to [email protected].