Helix Immersion Programme Partners

Overview of the Project and Purpose

This role involves overseeing customer projects, managing existing accounts and internal developments within Allozymes, ensuring they are completed on time, within scope, and within budget.

Main Objectives and Responsibilities

• Work closely with the Chief Technical Officer to ensure successful delivery of project outputs to schedule and within budgets.
• Overseeing customer projects and internal developments within an organisation, from the start through to completion 
• Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility
• Ensure resource availability and allocation for each project
• Formulate, organise and monitor inter-connected project
• Coordinate cross-project activities
• Develop detailed work breakdown structures and project plans to ensure delivery of agreed outcomes 
• Perform risk management to minimise project risks
• Create and maintain comprehensive project documentation
• Serve as the point of contact, to enhance collaboration between the business team and R&D team and ensuring timely execution of project
• Oversee project progress, addressing any issues with a focus on aligning Allozymes deliverables to the customers

Requirement of Qualifications, Skills and Experience

• Fresh PhD/Master’s in Science with commercial experience within the life science sector.
• Flexible approach to work assignments, ability to manage multiple and varied tasks and to prioritise the workload whilst maintaining attention to details
• Excellent interpersonal skills, verbal and written communication skills aligned with the ability to build and maintain strong relationships at sites and with service providers.
• >1 year working knowledge of program/project management preferred 
• Outstanding leadership and organisational skills

The biomechanical engineer will further the development of Castomize’s portfolio of medical device products from a biomechanics perspective. The current portfolio of products include orthopaedic casts and prosthetics.

This role is responsible for framing questions, conducting studies, analyzing data, interpreting results, communicating actionable insights, facilitating collaboration between internal product development teams and external problem owners, and prototyping ideas toward commercialisation. 

He/she will mainly be using 3D modelling design software and 3D printing techniques to conduct iterative prototyping and commercialization of products, along with other tasks related to product development and commercialization. 

Key Responsibilities 

• Use 3D modelling software to design Castomize’s products 
• Keep track of and report on product development progress 
• Use 3D printers, and oversee the 3D-printing process of prototypes to minimize errors 
• Provide inputs and suggestions to enhance the product development process 
• Work closely with the product development team to share knowledge and cross-develop 
• Liaise with external stakeholders regarding product development and production 
• In conducting studies, should have the ability to gather robust biomechanics data while gauging and incorporating subjective feedback, with the agility to adapt research methods 
• Data reduction, analysis, and interpretation 
• Clear, concise, actionable communication of research to designers and cross-functional audiences 
• Ability to zoom in and out - see the minute detail and big picture concurrently. 

Qualifications

• Master’s Degree or PhD in related fields 
• Proficiency in 3D modelling and design 
• 3-5 years research experience: musculoskeletal, soft tissue, prosthetic, exoskeleton biomechanics, and sports biomechanics 
• Experience with designing healthcare-related products is a plus 
• A passion for solving problems and providing value-added solutions with attention to detail 

About DotBio

DotBio is a highly innovative biopharmaceutical company with a mission to predict the most effective multi-functional antibody therapies cancer therapies and derisk the clinical development process. The company generates hundreds of multi-functional antibodies with good developability and screen them in parallel in high-throughput phenotypic assays (HTPAs) against diverse cancers. This combinatorial targeting approach allows to interrogate many immuno-oncology target combinations in parallel, generating a stack of data that can be analysed to identify the most potent and derisked antibodies to move into the clinic.

Project Description 

Are you a motivated professional in Pharmaceutical Science, Biochemistry, or a related field with a strong background in drug discovery? If so, we have an exciting opportunity for you!

DotBio is seeking an enthusiastic candidate to join our on-the-job training programme for Project Manager in IND-enabling studies. This programme is designed to provide hands-on experience and skill development, equipping participants with the knowledge and tools necessary to excel in managing IND-enabling studies including DMPK, toxicology, and manufacturing processes.

As a trainee in this programme, you will play a crucial role in supporting drug discovery and development by ensuring that the IND-enabling studies are conducted efficiently and effectively within the stipulated timeframes. You'll be immersed in real-world projects within the pharmaceutical and biotechnology sectors, gaining invaluable experience and insights.

Training Objective 

• Learn to identify, establish, negotiate, and maintain relationships with Contract Research Organisations (CROs) for both in vitro and in vivo investigations in IND-enabling studies
• Regularly review CRO performance to ensure timelines are met and data quality is maintained
• Review study-related documents (scope of work, protocols, amendments, and reports) for completeness, accuracy, and consistency with regulatory guidance
• Ensure all IND-enabling activities comply with relevant regulatory requirements and industry standards
• Oversee the execution of IND-enabling studies, ensuring adherence to project plans and timelines
• Monitor project progress and performance, addressing any issues or deviations
• Get acquainted with project management tools and software
• Provide regular project updates, highlighting progress, challenges, and necessary adjustments

Requirements

• PhD or MSc in a relevant field
• Solid understanding of IND-enabling studies’ principles and drug discovery
• Broad experience in biologics drug development and pharmacology
• Ability to interpret complex scientific data and make informed project decisions
• Strong organisational and time management skills
• Excellent interpersonal and communication skills along with a collaborative mindset
• Experience with regulatory submissions for biologics and/or small molecules would be an advantage
• Commitment to maintaining quality standards and regulatory compliance

Skills to be learnt

• Project Management
• Product Development
• Chemistry and Manufacturing Controls / Process Engineering
• Communication Skills
• Stakeholder Management
• Leadership

About Hilleman Laboratories

Hilleman Laboratories was established in 2009 as an equal joint venture between Merck Sharp & Dohme Corp. (MSD), a global research-driven pharmaceutical company and Wellcome Trust, a global charitable foundation dedicated to health. Hilleman Laboratories’ mission is to develop affordable vaccines and biologics against infectious diseases that affect low- and middle-income countries.

Hilleman Laboratories is establishing a first-of-its-kind vaccine and biologics development and manufacturing hub in Singapore comprising a 30,000 square foot current Good Manufacturing Practices (cGMP) facility and a state-of-the-art research and development facility.

Objectives

• Act as user representative/area owner in terms of technical transfer of process and product from R&D and CMC to GMP clinical manufacturing of different modalities and platforms to meet tech transfer objectives and timeline.
• Perform manufacturing and maintenance activities to ensure that critical manufacturing operations are on track and within budget.

Responsibilities

• Execute manufacturing activities in a safe and compliant manner.

• Ensure data is recorded in an ALCOA manner in the Manufacturing Batch Records (MBRs) and forms.

• Provide input to operation and equipment in the tech transfer activities of new product/process.

• Draft, author and/or provide inputs in documents consisting of but not limited to, facility fit assessment, user requirements, raw material identification, batch records, SOPs and process recipes.

• Perform front line troubleshooting of Fill finish equipment.

• Be part of the Total Productive Maintenance for Fill finish equipment.  

• Coordinate with relevant departments and stakeholders and track progress of operation to ensure project milestones are met.

• Perform and lead root cause analysis for operational related deviations and investigations using established problem-solving tools.

• Complete required training on time to ensure operations are conducted in a safe manner.

• Support process/equipment qualification/validation activities and studies.

• Front auditors during regulatory audits as the SMEs of the department.

• Perform cleaning of equipment and cleanrooms as and when necessary.

• Perform basic 5S housekeeping.

• Any other duties as assigned by supervisor.

Education, behavioural competencies and skills:

• Master's degree in an engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry) with 2-6 years relevant industry experience.
• Plant start-up or commissioning and/or operational experience in biologics and/or vaccines.
• Experience/knowledge of cGMP practices as applicable to fill finish processes is required.
• A thorough knowledge of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
• Well-organised and detail-oriented, with ability to effectively prioritise tasks with agility, eager to learn, interact and collaborate effectively with various stakeholders in a team environment and consistently demonstrate reliability and responsibility.
• Must be a team player with good working ethics, initiative, diplomacy, positive influencing abilities and drive.
• Good oral communication and demonstrable, exemplary writing skills.
• Experience with problem solving and statistical tools will be an advantage.

Skills to be learnt

• Chemistry and Manufacturing Controls / Process Engineering
• Chemical Engineering
• Fill Finish
• cGMP
• vaccine
• Biology

About ImmunoQs

ImmunoQs is a spin-off company from the Agency for Science, Technology and Research (A*STAR), Singapore. We help clinicians and drug developers to generate and analyse multiplex immunofluorescence images and spatial omics datasets, so that more effective drugs and more precise diagnostic assays can be developed. Our unique digital analytics platform allows researchers and clinicians to organise, visualise, and analyse large spatial omics data collected from pre-clinical to clinical studies. Our customers include leading medical centers, research institutes, and pharmaceutical companies in Singapore and other countries.

Overview

The candidate will work closely with the Digital Analytics Lab Director to help ImmunoQs’ clients or collaborators to analyse multiplex tissue images and spatial transcriptomics data. The candidate will also help to develop new data analytics workflow or products to make new spatial omics technologies more accessible to clinicians and researchers.

The candidate will have the opportunity to learn bioinformatics and data analysis software development process, and prepare for a possible career in this exciting field. He/she will have the opportunity to work in an interdisciplinary and start-up environment and learn how computational biology can help clinicians to fight cancers.

Responsibilities

• Perform image processing and quantify cellular phenotypes using ImmunoQs’ data analytics platform.

• Develop and implement data analysis workflow for new spatial omics technologies.

• Perform image quality control and annotate regions of interest from tissue images.

• Generate heatmaps, bar charts, or other graphs to represent the results.

• Document analysis methodologies, results, and records.

• Prepare reports and presentations to our clients or collaborators.

• Provide technical support and assistance to clients or collaborators.

• Support business development strategies and marketing efforts.

• Learn the latest spatial omics instruments, techniques, and data processing and analysis methodologies by reading papers and attending/participating in appropriate workshops, seminars, and courses.

Requirements

• Master or Ph.D. in computational biology, bioinformatics, bioengineering, biomedical science, biological science, life sciences, computer science, or other relevant fields.

• Proficiency in programming languages and software tools commonly used in bioinformatics and tissue image analysis, including R and Python, is required. Previous experience in using ImageJ/Fiji or QuPath is highly desirable.

• Good knowledge in data normalisation, RNA expression analysis, biological pathway enrichment analysis, clustering analysis, and basic machine learning algorithms are required. Previous experience in analysing spatial transcriptomics data (such as Visium, CosMx, GeoMx, or Stereo-seq) is highly desirable.

• Good knowledge in molecular biology, transcriptomics, cancer, and immunology. Previous experience in microscopy, imaging, or tissue staining is highly desirable.

• Preferably with 1 or 2 years of experience working in a research laboratory.

• Excellent analytical and problem-solving skills, with the ability to analyse complex data and draw meaningful conclusions.

• Strong attention to detail and ability to implement quality controls for reliable and accurate data analysis.

• Excellent verbal and written communication with good documentation skills.

• Ability to work collaboratively in a fast-paced and dynamic startup environment.

Skills to be learnt

• Product Development

• Machine Learning

• Product Management

• Data Analytics

• Marketing

• Data Visualisation

About Mirxes

An RNA technology company that develops and commercialises accurate, non-invasive, and affordable blood-based miRNA test kit products for the early detection of cancer and other diseases.

Roles and Responsibilities

• Deriving QA and QC guidelines pertaining to NGS data for in-house NGS workflows.
• Develop novel algorithms for genome assembly, variant detection (SNPs and InDels) and structural variant detection (CNVs, Inversions and Translocations) for a clinical-grade genome analysis.
• Setting up bioinformatics pipelines that are compliant to MOH and CAP standards.
• Lead development work to maintain and improve distributed workflow management infrastructure, LIMS, and other critical infrastructure.
• Supporting data analysis and troubleshooting during analytical validation and during routine operation.
• Writing the SOPs for bioinformatics pipelines and oversee the day to day running of the pipeline workflows.
• Support the patient results reporting process. Ability to extract SNVs, CNVs, indels and gene fusions from NGS data. Analyze clinical datasets to generate clinical diagnostic reports.
• Routine maintenance of the sequence data, including backup and storage of the clinical data.
• Identify and correct any weaknesses in systems or team processes related to security, completeness and quality of data analysis, efficient resource usage, or robustness.
• Perform other related duties as assigned.

Minimum Qualifications

• PhD or MSc in Bioinformatics or relevant industries
• Experience in leading algorithms/software development projects and teams.
• Strong experience developing bioinformatics algorithms and tools used in NGS analysis as evidenced by publications and GitHub repositories.
• Clinical experience or experience in clinical research, in cancer NGS/genomics would be highly desirable
• Experience developing Machine Learning algorithms is a plus.
• Experience in automating management of distributed systems in the Cloud, including provisioning, administering, testing, and monitoring.
• Experience with REST API design.
• Strong team player with positive work attitude, analytical minded, result-oriented, good communication and interpersonal skills

About

NousQ is a new medtech startup company that develops a surgical medical device in the Ear, Nose and Throat (ENT) field to address a key unmet healthcare need in glue ear treatment. It offers a novel solution by providing the world's first automated device that could revolutionise the current way of treating the condition. 

NousQ is proud to be the Top 5 winners of the Medtronic APAC Innovation Challenge 2022, and is honoured to be the winner of other innovation challenge such as MedTech Innovator Challenge APAC 2022 Accelerator Cohort, Victoria Health Week MedTech Festival as well as the recent China TusStar APAC Challenge. 

https://www.nousq.com/ 

Project Description

NousQ is a Singapore-based company focusing on research, design, develop, manufacture and commercialize medical technology and solutions that optimize healthcare delivery and serve large unmet needs for patients. The focus is on patient-centric solutions that patients really want and need.  Currently, NousQ is looking for a passionate firmware engineer to join our growing team.   

We want to introduce the world to CLiKX, a revolutionary and cutting-edge robotic medical device. CLiKX will transform glue ear surgeries by moving the procedure from the operating room to an outpatient setting. As a result, the time, money, and resources needed for such a procedure are significantly reduced.  

You will join our team of pioneer innovators in bringing CLiKX to the millions of untreated children who suffer from glue ears. 

Roles & Responsibilities

• Participate in ideation, conceptualization, design and iteration, verification and validation, manufacturing support for new product pipeline involving embedded system. 

• Be involved in design reviews to identify issues and derive robust solutions that meet the intended use, safety and effectiveness, as well as quality of the product. 

• Collaborate with manufacturing partners to communicate design concepts, technical and/or business trade-offs, and engineering solutions. 

• Perform firmware engineering tasks including:
  (1) Translate/refine high-level requirements into the architecture and engineering specifications of the firmware system;
  (2) Design, develop, integrate and debug/troubleshoot the embedded system/MCU-related hardware to meet the defined objectives, targeted cost and schedule;
  (3) Support the development and execution of relevant test plans, including unit test, integration test and system test to verify and validate that the product can meet all requirements;
  (4) Support functional and reliability tests to ensure safety and performance of the overall product systems. 

• Generate and maintain the necessary documentation for the firmware systems, including design documents, firmware architecture, schematics, SOP/work instructions, Device Master Record (DMR) and other documentations needed to meet the regulatory requirements such as Design History File (DHF), IEC62304, ISO13485 & FDA 21 CFR Part 820. 

• Oversee firmware design change orders and support any relevant verification and validation activities. 

• Support ad-hoc administrative duties as and when required to ensure smooth operation of the company’s activities. 

Minimum Requirements

• Master’s/PhD degree in Biomedical/Electronics/Computer Engineering with experience in embedded system development. The engineer will be a part of the startup team focusing on product realisation process. 

• Good understanding of product realisation process and preferably with prior experience or interest in embedded system design and development processes. 

• Relevant experiences include coding with programming language such as C/C++ and/or competent in applying other similar IDEs/toolchains for firmware development. 

• Knowledgeable in quality concepts including verification and validation, and reliability testing. 

• Good understanding of medical device software regulatory requirements, such as IEC62304 and/or FDA Software in Medical Device requirements. 

• Excellent communication skills in spoken and written English and good inter-personal skills to engage and interact with team members, vendors, consultant and any potential third party. 

• Possess a high level of integrity, independent, self-motivated and enjoy working in a fast-paced startup environment. 

• Experience in electronic circuit design and/or AI/ML-related development is a plus. 

Skills to be learnt

• Electronics 

• Printed Circuit Board (PCB) Design 

• Product Development 

• Product Management 

• Usability Design 

• Hardware Design 

​​​​​​​About PairX Bio

PairX Bio is a precision oncology company developing next generation therapeutics targeting cancer-associated antigens derived from alternatively spliced proteins. The PairX Bio discovery platform is built upon a deep understanding of mRNA splicing biology and robust validation of identified targets. The technology was developed and spun out from Professor David Epstein’s lab at Duke-NUS Medical School.

Job Description

Join our innovative and exciting oncology startup as a Bioinformatician, where you'll gain exposure to the early-stage biotech environment, develop your critical thinking, and participate in making informed decisions about target selection. Leveraging your expertise in bioinformatics and computational biology you will collaborate closely with our team of scientists and play a pivotal role in analysing and interpreting complex transcriptomic and molecular data to contribute to the identification of novel therapeutic targets and the development of cutting-edge treatments.

Responsibilities

1. Develop statistical and machine learning methods to identify therapeutic targets.
2. Contribute to development of data analysis workflows for NGS data, ensuring reproducibility and scalability of analyses.
3. Communicate and work with the discovery team to design experiments and validate findings.
4. Document analysis workflows and their associated data flow into SOPs, work instructions, protocols, and other technical documentation.
5. Manage and organise multiple target programs concurrently.
6. Present findings and insights to both technical and non-technical audiences, including team members, management, and potential collaborators.

Job Requirements

1. Ph.D. in Computational Biology, Bioinformatics, Biostatistics, or a related field, with experience in analysis of large-scale omics data sets (NGS data).
2. Strong programming skills in R, Python, and/or other languages commonly used in bioinformatics and data sciences.
3. Proficiency with Unix-based systems and running or scripting applications from the command line.
4. Familiarity with public genomics databases/resources and data processing
5. Knowledge of statistical analysis, machine learning, and data visualisation techniques applied to biological data.
6. Knowledge of cloud computing environments (especially AWS), server maintenance and upkeep.
7. Previous experience in the oncology space and downstream molecular biology analysis is a plus.
8. Experience in RNA splicing analysis is highly desirable.
9. Strong communication skills and ability to collaborate effectively in a multidisciplinary team environment.

This project is in partnership with Trinity Innovation Bioventure Singapore (TIBS) and National Health Innovation Centre Singapore (NHIC). 

About Trinity Innovation Bioventure Singapore

Trinity Innovation Bioventure Singapore (TIBS) is a licensed biomed venture capital fund focusing on innovation and value investment with deep insight and experience on Asia markets. The team is led by industrial veterans who have managed multiple VC funds and invested in over dozens of biotech companies. 

Job Description 

TIBS is seeking an entrepreneurial Venture Building Lead to support the incubation and growth of early-stage biotech companies in Singapore. The Venture Building Lead will work closely with scientific researchers, entrepreneurs, investors, and other stakeholders to transform scientific breakthroughs into globally competitive biotech companies. This role requires a combination of drug discovery knowledge and business skills to support early-stage companies in building a strong foundation for growth. 

Roles and Responsibilities: 

• Lead the venture building projects and support the collaborations with research institutes in Singapore.

• Source investment opportunities to translate scientific breakthroughs into a corporate venture. 

• Lead or support new venture building including research plan, budget forecast, market landscape analysis, team recruiting and risk control plan. 

• Conduct market research to understand the demand, competition, and feasibility of new ventures. 

• Perform research in the scientific field and gather intelligence by establishing the key business drivers, determining the barriers to entry and identifying the key competitors. 

• Support fundraising activities for the incubation projects. 

• Build partnerships with key players in the biotech ecosystem, including research centres, corporate partners, and government agencies. 

• Offer hands-on support to startups in areas like project management, strategic planning, and problem-solving. 

Requirements 

• Education: Advanced degree in biomedical field (e.g., Biology, Medicine, MD). 

• Experienced with biotech startups, research institutes, or a similar field. 

• Industry Knowledge: Good understanding of drug discovery protocol, and the biotech startup landscape. 

• Financial Skills: Experience with financial modelling and venture financing is a plus. 

• Analytical Skills: Ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. 

• Others: Good interpersonal skills, and ability to persuade, negotiate and influence 

About Vivo Surgical 

Vivo Surgical is a patient-focused, clinically-driven medical device developer and manufacturer. Headquartered in Singapore with commercial and co-innovation partnerships spanning multiple international territories, the company is pioneering a novel endoscopic robot for complex endoluminal procedures along the gastrointestinal tract. ISO 13485 certified with international accreditations such as the FDA and CE mark, Vivo Surgical’s proprietary devices target the medical needs of the world through innovative applications of science & technology.

Overview

Project Description

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organise and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Master’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritise tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

About Xenolis

Xenolis Pte Ltd is a platform-based life sciences company focusing on the development of synthetic aptamers. Leveraging on our unique technologies, we are developing DNA and RNA-based solutions in their field of use. We are currently seeking motivated Research Scientists to join our R&D team in Singapore.

Responsibilities

• Generate and characterise nucleic acid aptamers
• Develop a new biotechnology based on genetic alphabet expansion
• Perform a variety of assays (e.g. cell signalling bioassay, internalisation/trafficking assay, protein-based and cell-based binding assays) and immunological-related assays (e.g. ELISA, flow cytometry)
• Perform mammalian cell culture experiments and maintenance
• Maintain detailed documentation of research, protocols, SOPs, inventories, maintenance logs, etc
• Take on laboratory management duties including but not limited to procurement, inventory management, laboratory equipment maintenance
• Ensure compliance with standard operation procedures, in-house safety measures and other industry practices

Job Requirements

• Knowledge of basic chemistry/biology and molecular biology, including nucleic acid research
• PhD, a Master degree, or a Bachelor degree in a Life Science, Biological Science, Biochemistry or related disciplines
• Wet lab experience with chemistry and biology for nucleic acids and proteins
• Proficient with high-dimensional data analysis, and familiar with the use of genomic analysis, computational biology, statistical and visualisation tools
• Experienced in cell culture and molecular lab techniques
• Excellent organisational skills
• Excellent interpersonal and verbal/written communication skills
• Self-motivated with a proactive attitude
• Strong troubleshooting and problem-solving skills
• Ability to work independently and collaboratively with team members in a fast-paced biotech startup