Process Development Associate

ESCO ASTER PTE LTD; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

Esco Lifesciences Group seeks a scientifically driven professional to perform research and process development for biologics, collaborating with internal and external stakeholders to translate bench work into scalable GMP manufacturing processes.

The role emphasizes cGMP compliance, meticulous documentation, and the ability to drive timelines while learning new techniques and supporting cross-functional teams in a fast-paced environment.”

Qualifications

• Experience with GLP and GMP is an advantage.
• Proficient in MS Office (Word, PowerPoint, Excel).
• Experience in cultivation of mammalian cells in lab scale and in bioreactor systems.
• Experience in downstream processing techniques such as tangential flow filtration, chromatography, ultrafiltration.
• Strong communication and organizational skills.
• Team player with interpersonal skills.
• Ability to work independently and as part of a team, self-motivated.

Responsibilities

• Perform research and process development activities, mainly in support of biologics production, with internal and external stakeholders.
• Collaborate with clients and partners to advance CDMO objectives.
• Draft and maintain SOPs, batch records, and workflow diagrams for GMP manufacturing operations.

Skills

Mammalian cell culture

Bioprocess development

Process optimization

Data analysis

GLP GMP knowledge

Education

Bachelor/Master's degree in Biology, Chemistry, Pharmaceutical Sciences or related science

Tools

MS Office Suite

Bioreactor systems

Tangential flow filtration

Chromatography equipment

Job description

Esco Lifesciences Group is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania.

Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017. Our company is a contract research development and manufacturing organization that are founded and deeply rooted by scientists that enables fellow scientists to translate their bench work into commercially available products at affordable prices.

Our scientific work involves in the field of emerging biotechnologies where we are developing cells as a final product or leveraging them as cellular factories to produce target modalities. Our first commercial breakthrough success is being first in the world to be certified by established food regulatory body for commercial production cultivated/cell-based meat. Our second milestone focuses on manufacturing engineered extracellular vesicles to support a Phase I oncology clinical trial in US.

We have established an end-to-end, integrated suite of capabilities that encompasses cell line development, upstream cultivation of cells, downstream purification and analytical testing. Operating under cGMP compliance, this centralized infrastructure supports both drug substance and drug product manufacturing across a diverse range of biologic modalities.

The work we do creates a remarkable and lasting impact on our world. We offer you an opportunity to be part of this exciting journey to own your career and firsthand exposure to new emerging modalities supporting translational sciences.

Join us as we redefine BioSolutions for One World and One Health for the current and future generations to come.

One World Biosolutions for One Health.

The Scope

You will be part of Esco Aster’s scientific division and contribute to the company’s CDMO mission and objectives. You will perform research and process development activities, mainly in support of the production of biologics, in collaboration with internal and external stakeholders, clients and partners.

Desired profile of candidate

Technical competency:

• Demonstrated competency in designing, optimization/improvements and troubleshooting laboratory scale experiments on either two major areas, which include:
• a) Cultivation of mammalian cells and analysis of the cellular mechanism in promoting growth and production of biologics.
• b) Purification of various biologics modalities produced from cells using processes such as tangential flow filtration, chromatography and filtration.

• Support process development and process characterization studies to scale up mammalian cell culture and/or purification processes for technology transfer into cGMP manufacturing processes.
• Ability to collate, analyse and interpret the experimental data to define subsequent steps and contributing to the scientific and operational improvements to the overall manufacturing process.
• Drafting and documentation of process SOP, batch records and workflow diagram for GMP manufacturing operations.

The candidate should also:

• Understand and be willing to work under cGMP manufacturing environment during the process development stage.
• Meticulous and organized in scheduling experimental assays, documentation of experimental reports, and drafting protocols in accordance with Good Documentation Practice (GDP) and cGxP requirements.
• Take ownership of experimental timelines by ensuring that all experiments are executed on schedule, and results are systematically compiled and submitted timely to all relevant stakeholders for review.
• Ability to communicate and explain experimental results effectively with internal stakeholders and identify logical next steps of the experiment.
• Demonstrates a positive and proactive attitude and towards guidance. Willingness to learn new process techniques and demonstrate interest to continuous deepen skill expertise.
• Demonstrate collaborative efforts with cross functional teams to support the establishment of process in GMP settings.
• Perform tasks in accordance with applicable regulations and site safety requirements.
• Undertake other tasks as assigned based on project needs. Able to maintain schedule flexibility to accommodate experimental timepoint and workflow demands.

Requirements

• Bachelor/Masters degree in Biology, Chemistry, Pharmaceutical Sciences or related science.
• Experience with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) will be an advantage.
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
• Experience in cultivation of mammalian cells in laboratory scale and in bioreactor systems.
• Experience in downstream processing techniques such as tangential flow filtration, chromatography, ultrafiltration.
• Strong computer, scientific, and organizational skills.
• Excellent communication (oral and written) and attention to detail.
• Strong team player, develop positive relationship with a strong set of interpersonal skills.
• Ability to work independently and as part of a team, self-motivated, adaptable, and has a positive attitude.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Ability to work on complex assignments independently and take a high degree of initiative to resolve issues
• A friendly and pleasant disposition.