Total 14 job vacancies by Prestige Biopharma Limited

Job Description

• Develop, validate and perform bioassays and bioanalytical assays in compliance with FDA/EMA and GLP guidelines
• Refine current method in response to changing requirements of drug development
• Prepare study plan and study data of assays performed
• Analyse and present data/results
• Document work, results, analyses and findings in laboratory notebooks or study folders as appropriate according to workflow
• Draft SOPs and study reports
• Perform literature review for various drug pipelines and assays as required
• Meet project milestones with set quality
• Ensure scientific integrity of studies conducted and reports submitted

Requirements

• BSc or MSc in biomedical science, life science or equivalent
• Prior research and development experience are required
• Proficient in mammalian cell culture and aseptic techniques is a must
• Experience in ligand binding assays mainly ELISA, cell-based assays, SDS-PAGE, western blot and reporter assays is highly desirable
• Good knowledge of cell based (potency) or ligand binding assays required in drug development process
• Proficient with office software (MS office, Teams), and familiar with statistical tools (Graphpad Prism, XLSTAT or PLA)
• Knowledge of bioassays, bioanalytics and its method validation, GLP and ISO17025 is a plus
• Good written and verbal communication skills
• Superior problem solving and troubleshooting skills, attention to details
• Good interpersonal skills

Job Description

• Project support: Oversee and support project management activities, including planning, timeline monitoring, and budget tracking, to ensure timely completion of projects for regulatory submissions.
• Project monitoring: Track and report project status to internal and external stakeholders, ensuring deadlines are met for ongoing projects. Provide expert CMC support while monitoring CMO/CDMO activities.
• Documentation management: Manage and maintain project documentation, including protocols, reports, SOPs, and meeting minutes. Facilitate the collection of information from both internal and external stakeholders in a timely manner.
• Stakeholder management: Coordinate external collaborations, including managing agreements and overseeing the quality of deliverables. Monitor activities of CMOs, CDMOs, and other partners.
• Sample and logistics coordination: Handle project logistics, including sample shipment and drug sourcing.
• Regulatory support: Assist in drafting the Quality Section of dossiers for clinical trial and marketing authorization applications, ensuring alignment with regulatory requirements and agency expectations.
• CMC support: Offer strategic guidance to technical teams on CMC regulatory requirements and engage in negotiations to resolve CMC-related issues.
• Others: Perform other duties as assigned by leadership

Job Requirements

• MSc, or BSc in life science/ chemistry
• Experience with office management software like MS office (MS Excel, MS Word, MS PowerPoint) and other project management software
• Strong management and organization skills, attention to details, good written and verbal communication skills
• Superior time-management skill, able to multitask and quickly adapt to dynamic changes
• Knowledge in drug development process and technical/ scientific knowledge.

Job Overview:

We are seeking a highly motivated and detail-oriented Clinical Trial Assistant to join our team. The Clinical Trial Assistant will serve as the unblinded point of contact for logistics vendors and unblinded Clinical Research Associates (CRAs), responsible for managing various aspects of clinical trial logistics and documentation. The successful candidate will have excellent organizational skills, the ability to work independently, and strong emotional intelligence. This role requires proficiency in Microsoft Office applications and at least 1 year of experience managing clinical trials in a pharmaceutical company, Contract Research Organization (CRO), or clinical trial site.

Key Responsibilities:

• Serve as the unblinded point of contact for logistics vendors and unblinded CRAs.
• Generate and review shipment documents, including batch records, Certificate of Conformance (CoRC), temperature logger data, etc.
• Manage investigational product (IP) inventory and ensure proper storage and distribution.
• File unblinded Trial Master File (TMF) documents in accordance with regulatory requirements.
• Review unblinded monitoring reports and address any discrepancies or issues as needed.

Qualifications:

• Good emotional intelligence skills, with the ability to communicate effectively and maintain professionalism in challenging situations.
• Ability to work independently and manage multiple tasks simultaneously, with strong attention to detail.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• At least 1 year of experience in relevant experience managing clinical trials in a pharmaceutical company, CRO, or clinical trial site.
• Bachelor's degree in a relevant field (e.g., life sciences, healthcare, etc.) preferred.

Responsibilities

· Sourcing and purchasing of lab consumables.

· Manage inventory of general consumables and chemicals.

· Maintain laboratory records and equipment maintenance records.

· Support internal and external laboratory audits.

· Perform regular internal verification of the monitoring device in the laboratory.

· Work closely with all laboratory personnel to ensure proper housekeeping and general upkeep of the laboratory equipment.

· Perform regular laboratory safety checks.

· Liaise with external vendors for consumable delivery arrangements, laboratory waste collection, equipment repair/calibration/maintenance.

· Response to fridge/ freezer alarm to rectify the issue in a timely manner.

· Laise with vendors for emergency generator and other facilities maintenance.

Requirements

· Diploma in Biologics, process, or electrical engineering.

· Min 2 years of working experience in a Lab environment

· Keen learner and can adapt to flexible working environment

· Good communication skills

Company Overview:

Prestige Biologics Co., Ltd is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercialization.

Responsibilities:

The Engineering Manager provides essential technical support to the manufacturing site’s engineering and maintenance team in Korea, ensuring seamless operations. The role also involves leading the implementation of engineering best practices and serving as the main point of contact for internal and external stakeholders on all engineering-related matters.

· Oversee and ensure efficient site engineering operations while maintaining full compliance with regulatory requirements.

· Provide leadership and management for the Engineering & Maintenance functions, including automation, projects, utilities, calibration, maintenance, and process engineering.

· Evaluate and implement robust engineering practices, such as predictive maintenance and reliability engineering programs.

· Offer technical expertise in the design, implementation, maintenance, and optimization of manufacturing systems, equipment, and processes. This includes developing User Requirement Specifications (URS) and participating in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and validation processes. A strong understanding of Good Manufacturing Practices (GMP) and industry standards related to pharmaceutical production is essential.

· Lead engineering projects with effective project management skills, focusing on facility upgrades, expansions, and the introduction of new equipment or technologies.

Requirements:

Versatile with strong technical expertise in engineering disciplines such as utilities operation, automation, process engineering, calibration, and maintenance.

· Minimum of a bachelor’s or master’s degree in an engineering or science-related field.

· At least 7-10 years of experience in engineering, maintenance and project management within the pharmaceutical industry.

· Exceptional critical thinking skills with the ability to prioritize effectively.

· Strong problem-solving and decision-making abilities.

· Proven leadership and management capabilities.

· Adaptable, flexible, and collaborative, with a high comfort level in managing change.

· Excellent communication skills with the ability to inspire and motivate teams.

· Demonstrated track record of delivering results.

Company Overview:

Prestige Biologics Co., Ltd is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in drug discovery from early stage to product registration and commercialization.

Position Overview:

As our company is in the growing phase, we are seeking a dynamic and customer centric Marketing Intern to support our business development activities. The ideal candidate will get to have hands-on experience in both inbound and outbound marketing activities. This individual should have creative mindset to help us remain fresh and competitive in the biopharmaceutical industry. This role will collaborate with cross-functional teams locally in Singapore as well as in South Korea and contribute to growing our sales pipeline.

Key Responsibilities:

1) Market Research and Analysis

· Conduct market research to identify industry market trends, customer needs and competitive landscape.

· Develop intelligence reports for the CDMO market.

2) Develop and Execute Marketing Strategies

· Collaborate with team members to execute marketing campaigns and leading brainstorming sessions for internal and external projects.

· Support marketing lead generation activities with the aim to grow sales pipeline.

3) Content Development

· Develop contents for marketing collateral, digital assets, and promotional materials, communicating value proposition to target audiences.

· Create contents for posting on social media account

· Support SEO, SEM for corporate websites to drive sales traffic.

4) Stakeholder Collaboration

· Support Business Development team in Go-to-Market strategy.

Technical Skills that intern will learn:

· Basic understanding of drug development cycle from discovery to clinical trials phases to launched product.

· Basic understanding of GMP (Good Manufacturing Practices), GDP (Good Documentation Practice) and compliance requirements.

· Familiarity with Customer Relationship Management tools (e.g. Salesforce, Hubspot).

· Familiarity with clinical databases (e.g. Global Data, Clarivate, Citeline etc).

Qualification

· Educational Qualifications:

o Diploma in Life Sciences/ Pharma, Business Administration or relevant field.

Interpersonal Skills

· A good team player with collaborative spirit to work effectively with cross-functional teams.

· Proactive nature to identify and resolve challenges encountered.

Technical Skills:

• Manage delivery of projects through full EDC data management study life-cycle (with minimal guidance).

• Perform comprehensive data management tasks including data review, writing, and resolving data clarifications.

• SAE Reconciliation, Query management, Listing’s review.

• Develop and manage DM documents like Data Handling Plan (DHP), Data Review Plan (DRP), Data Management Plan for assigned trials, Manual Listings plan and validation.

• Case Report form design and review.

• Ability to perform EDC testing including test case creation, UAT.

• Work closely with the internal/external cross-functional team (CRAs, Project Managers and Statisticians) to ensure all the data related issues are resolved.

• Communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned.

• To undertake other reasonably related duties as may be assigned from time to time.

• Manage multiple projects, ensuring that timelines are met, and deliverables are of utmost quality

Additional Skills:

• Ability to successfully manage multiple tasks and timelines

• Ability to perform assigned tasks with little supervision

• Ability to liaise professionally with team members

• Strong verbal and written communication skills in English

• Demonstrated ability to learn new technologies, applications, and techniques

• Knowledge of ICH-GCP, 21CFR Part 11

Qualification:

• Bachelor's degree, or educational equivalent, in clinical, biological sciences, or related field, or nursing qualification with 4+ years of experience in core Clinical Data Management.

Job Description

• Project support: Oversee and support project management activities, including planning, timeline monitoring, and budget tracking, to ensure timely completion of projects for regulatory submissions.
• Project monitoring: Track and report project status to internal and external stakeholders, ensuring deadlines are met for ongoing projects. Provide expert CMC support while monitoring CMO/CDMO activities.
• Documentation management: Manage and maintain project documentation, including protocols, reports, SOPs, and meeting minutes. Facilitate the collection of information from both internal and external stakeholders in a timely manner.
• Stakeholder management: Coordinate external collaborations, including managing agreements and overseeing the quality of deliverables. Monitor activities of CMOs, CDMOs, and other partners.
• Sample and logistics coordination: Handle project logistics, including sample shipment and drug sourcing.
• Regulatory support: Assist in drafting the Quality Section of dossiers for clinical trial and marketing authorization applications, ensuring alignment with regulatory requirements and agency expectations.
• CMC support: Offer strategic guidance to technical teams on CMC regulatory requirements and engage in negotiations to resolve CMC-related issues.
• Others: Perform other duties as assigned by leadership

Job Requirements

• MSc, or BSc in life science/ chemistry
• Experience with office management software like MS office (MS Excel, MS Word, MS PowerPoint) and other project management software
• Strong management and organization skills, attention to details, good written and verbal communication skills
• Superior time-management skill, able to multitask and quickly adapt to dynamic changes
• Knowledge in drug development process and technical/ scientific knowledge.

About the Job:

We are seeking highly motivated and innovative Bioassay Scientists who are passionate about biologic drug development to join us in our fast-growing R&D Lab. The applicant for Scientist should demonstrate competency in designing and developing assays independently.

ROLES, RESPONSIBILITIES & EXPECTATIONS

• Develop, validate, and perform cell-based functional assays and ligand binding assays in compliance with regulatory guidelines.
• Develop, validate, and perform PK/immunogenicity assays of clinical trial samples in compliance with regulatory and GLP guidelines.
• Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, SOPs, Good Laboratory Practices (GLP) and regulatory guidelines.
• Deliver quality data on time to meet project timelines.
• Prepares and reviews study protocol/plan, SOPs, study reports, and other technical documents.
• Provide technical and scientific expertise as required.
• Ensure scientific integrity of studies conducted and reports submitted.
• Train and mentor junior staffs or interns.
• Perform other tasks as assigned by supervisor.

REQUIREMENTS AND QUALIFICATIONS

• PhD in life sciences or equivalent with 1-2 years of relevant experience or fresh graduate with PhD training research experience in cancer biology/immunology/molecular biology are welcome to apply.
• Proficiency in mammalian cell culture and aseptic techniques is a must.
• Knowledge and proficiency in cell-based assays including antiproliferation assays, reporter gene assays, or cytotoxicity assays is highly desirable.
• Experience in ligand binding assays such as ELISA, BLI/Octet, SPR or flow cytometry.
• Knowledge or experience in pharmacokinetics or immunogenicity assays.
• Experience using GraphPad Prism, XLSTAT or PLA analysis software.
• Direct experience with assay development and troubleshooting.
• Strong verbal and written communication skills.
• Demonstrated abilities to learn new skills quickly, think independently, and work collaboratively.
• Hard-working, self-motivated, detail-oriented, highly organized, and able to adapt quickly to changes.

Job Description

Reporting to the Financial Systems Manager, this position drives the following processes and activities to enhance internal controls, governance and risk management in the organization:

Internal Control over Financial Reporting (ICFR):

· Assist with the establishment of design and operation evaluation plan for ICFR (K-SOX)

· Support internal and external audits requirements as well as follow-up measure implementation

· Understanding the job processes of functional departments

· Identify opportunities for improvement on financial systems processes

· Work closely with internal stakeholders to identify workflow gaps

· Collaborate closely with internal stakeholders across different organization level to facilitate smooth execution of audit fieldwork and monitoring

· Perform daily controls monitoring

· Other ad-hoc tasks related to job processes and internal control

Financial Planning:

· Assist in assigned tasks relating to Risk Management and Financial Planning

Job Requirements

· Bachelor's degree in finance/accounting or equivalent

· At least 2-3 years of Big 4 audit experience

· Good auditing skills with a good understanding of internal controls/risk management concepts

· Healthcare or Pharma experience will be an added advantage

· Experience in SOX would be advantageous

Skills

· Problem-solving skills

· Independent and self-motivated team player

· Possess a can-do attitude and ability to articulate ideas and challenge conventions

· Communication and collaboration skills

· Thorough knowledge of accounting and auditing practices and principles

· Comfortable working with ambiguity

· Flexible and able to adapt to a fast-changing environment

· Works independently under minimal supervision

Job Description:

• Maintaining accurate records for all transactions
• Accounts payables: recording suppliers’ invoices and preparing payments
• Accounts receivables: preparing and recording invoices
• Bank reconciliation
• Prepare GST submission
• Prepare monthly financial and management reports;
• Assist in group consolidation reports;
• Support audit and tax queries;
• Liaise with banks on banking transactions;
• Support the operational teams in maintaining strong vendor relationships.

Requirements

• Diploma in Accounting & Finance or equivalent;
• At least 2 years of experience in accounting & finance;
• Strong understanding of accounting principles;
• Ability to work independently with a high degree of accuracy and efficiency;
• Hands-on experience with SAP would be an advantage.
• Proficient in Microsoft Excel

Job Responsibilities

Overall Project Management:

• Oversee project planning, documentation, timelines, and budget management.

Coordination of Quality Section in Dossiers:

• Coordinate internal and external activities related to the Quality section of dossiers.
• Provide strategic guidance to technical teams regarding CMC regulatory requirements.

Review and Compliance Oversight:

• Review technical documents from various teams for accuracy, compliance, and completeness for regulatory submissions.

Due Diligence and Regulatory Agency Meetings:

• Prepare briefing packages and support cross-functional teams in due diligence and regulatory agency meetings.
• Engage in negotiations to address and resolve CMC issues.

Dossier Authorship:

• Author and drive completion of the Quality section of dossiers for clinical trial and marketing authorization applications.
• Ensure final versions align with requirements and meet regulatory agency expectations.

Subject Matter Expertise:

• Monitor activities of CMO/CDMO and provide CMC subject matter expertise.
• Review or approve technical documents (e.g. tech transfer documents) and address or escalate CMC/Quality issues.

Vendor Management and Procurement:

• Assist in vendor discussions, procurement processes, and shipment activities.

Workflow Optimization:

• Identify inefficiencies and improve workflows to ensure the efficient operation of the CMC and Bioanalysis department.

Collaboration and Goal Achievement:

• Collaborate with Team Leaders and members of the CMC Lab and Quality Assurance to ensure department goals are efficiently met.

Regulatory Intelligence:

• Stay informed about relevant industry and agency guidance to maintain regulatory intelligence.

Job Requirements

• A bachelor's, Master, or PhD degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Sciences).
• Demonstrated experience in overall project management. Certification in project management (e.g., PMP) would be advantageous.
• In-depth knowledge and understanding of Chemistry, Manufacturing, and Controls (CMC) regulatory requirements and processes, particularly in the authoring or management of Quality sections of dossiers for clinical trial and marketing authorization applications of biologics drug.
• Strong collaborative skills, with the ability to work effectively with cross-functional teams, vendors, and alliance partners.
• Meticulous in reviewing technical documents to ensure accuracy, compliance, and completeness.
• Knowledge of bioprocessing, functional assays and physiochemical characterization of monoclonal antibody is a plus.

Company Overview:

Prestige Biologics Co., Ltd is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in your drug discovery from early stage to product registration and commercialization.

Based on our fully established antibody drug & vaccine manufacturing capabilities, we now offer our upgraded CDMO service, CDEMO in which we provide customized engineering solutions for your manufacturing process in a customized manufacturing suite speed-built with our proprietary technology, ALITA Smart BioFactory™.

Position Overview:

We are seeking a dynamic and experienced International Business Development Director to drive our global expansion efforts and forge strategic partnerships worldwide. The successful candidate will be responsible for identifying new business opportunities, cultivating relationships with key stakeholders, and executing strategies to drive revenue growth and market penetration in international markets.

Key Responsibilities:

Market Analysis and Strategy Development:

• Conduct thorough market research to identify emerging trends, competitive landscape, and growth opportunities in target regions.
• Develop comprehensive business development strategies and action plans to expand market presence and achieve revenue targets.

Client Relationship Management:

• Cultivate and maintain strong relationships with existing clients, understanding their needs and objectives to identify opportunities for upselling and cross-selling.
• Proactively engage with potential clients, understanding their requirements, and offering tailored solutions to address their specific needs.

New Business Development:

• Lead the identification, evaluation, and pursuit of new business opportunities in international markets, including strategic partnerships, licensing agreements, and joint ventures.
• Develop and execute effective sales strategies and presentations to pitch company services and capabilities to potential clients.

Negotiation and Contract Management:

• Lead negotiations with clients and partners to secure favorable commercial terms and agreements, ensuring alignment with company objectives and financial targets.
• Oversee the preparation and review of contracts, proposals, and other legal documents, working closely with internal stakeholders and legal counsel.

Collaboration and Team Leadership:

• Collaborate closely with cross-functional teams, including marketing, operations, quality and finance, to ensure seamless execution of business development initiatives.
• Provide leadership, guidance, and mentorship to the business development team, fostering a culture of excellence, accountability, and continuous improvement.

Qualifications:

• Degree/Masters/PhD in Life Sciences, Biomedical Science, Biotechnology, Bioengineering, Business Administration, or related field; MBA or advanced degree preferred.
• Minimum of 8-10 years of experience in international business development, preferably within the CDMO and pharmaceutical industry.
• Proven track record of successfully identifying business opportunities, closing deals, driving revenue growth, and exceeding targets.
• Strong understanding of global markets, regulatory requirements, and industry trends.
• Exceptional negotiation, communication, and interpersonal skills.
• Strategic thinker with the ability to develop and execute effective business development strategies.
• Demonstrated leadership ability, with experience leading and motivating teams to achieve results.
• Job will be based in Singapore, willingness to travel internationally as needed.

Company Overview:

Prestige Biologics Co., Ltd is a biopharmaceutical CDEMO (Contract Development Engineering Manufacturing Organization) that provides complete solutions to the development and manufacturing requirements in your drug discovery from early stage to product registration and commercialization.

Based on our fully established antibody drug & vaccine manufacturing capabilities, we now offer our upgraded CDMO service, CDEMO in which we provide customized engineering solutions for your manufacturing process in a customized manufacturing suite speed-built with our proprietary technology, ALITA Smart BioFactory™.

Position Overview:

We are seeking an experienced and technically proficient Senior Business Development Manager to lead our business development efforts with a specialized focus on technical aspects within the CDMO sector. The ideal candidate will possess a deep understanding of drug development and manufacturing processes, enabling them to effectively communicate our capabilities and tailor solutions to meet the unique needs of our clients.

Key Responsibilities:

Technical Expertise:

• Serve as a subject matter expert on drug development and manufacturing processes, including Drug Substance/Drug Product/API synthesis, formulation, analytical testing, and regulatory requirements.
• Collaborate with internal technical teams to assess client needs, provide technical insights, and develop innovative solutions that align with client objectives.

Business Development Strategy:

• Develop and implement strategic business development plans with a focus on leveraging technical expertise to drive revenue growth and expand market presence.
• Identify emerging market trends, technological advancements, and competitive landscape to inform strategic decision-making and opportunity identification.

Client Engagement and Relationship Management:

• Cultivate and maintain strong relationships with key clients, understanding their technical requirements and challenges to provide tailored solutions and foster long-term partnerships.
• Act as a trusted advisor to clients, providing technical guidance, resolving issues, and ensuring the successful execution of projects from inception to completion.

New Business Acquisition:

• Assist BD Director in the identification, evaluation, and pursuit of new business opportunities, including strategic partnerships, collaborations, and licensing agreements.
• Assist BD Director to develop and deliver compelling sales presentations and proposals to prospective clients, effectively articulating the value proposition of our services and capabilities.

Negotiation and Contract Management:

• Assist BD Director in negotiations with clients and partners to secure favorable terms and agreements, ensuring alignment with company objectives and financial targets.
• Assist BD Director in the preparation and review of contracts, proposals, and other legal documents, working closely with internal stakeholders and legal counsel.

Market Intelligence and Analysis:

• Monitor industry trends, competitor activities, and regulatory developments, providing insights and recommendations to inform business development strategies.
• Stay abreast of market dynamics and customer needs, adapting sales approaches and strategies accordingly to maintain a competitive edge.

Qualifications:

• Bachelor's degree in Pharmaceutical Sciences, Biomedical Science, Biotechnology, Chemistry, Chemical Engineering, or related technical field; advanced degree (e.g., MBA, MS, PhD) preferred.
• Minimum of 5-10 years of experience in business development or manufacturing operation within the pharmaceutical or biotechnology industry, with a strong technical background in drug development and manufacturing.
• Proven track record of driving revenue growth and exceeding sales targets in a technical sales environment.
• In-depth knowledge of drug development processes, including API synthesis, formulation, analytical methods, quality management systems and regulatory requirements (e.g., FDA, EMA).
• Excellent communication, presentation, and interpersonal skills, with the ability to effectively communicate complex technical concepts to diverse audiences.
• Strategic thinker with the ability to identify market opportunities, develop actionable plans, and execute effectively to achieve business objectives.
• Strong leadership and collaboration skills, with experience leading cross-functional teams and fostering a culture of innovation and excellence.