×
 
Submitted by sarah.goh@sgin… on Mon, 01/27/2025 - 11:53
Designation
Manufacturing Biotechnologist
Description

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. 

 

Job Description 

The incumbent will be involved in day-to-day support in biologics and vaccine manufacturing operation by providing operation/maintenance input and facilitate decision making. He/she will 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. He/she will commission the first-of-its-kind multiproduct cGMP manufacturing suites (mammalian and microbial) within the project timeline and budget. 

  

Roles and Responsibilities 

  • Responsible for ensuring that the manufacturing activities are performed in accordance with EHS guidelines and in a cGMP-compliant manner. 

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

  • Draft, author and/or provide inputs in documentations such as facility fit assessment, user requirements, raw material identification, batch records, SOPs, and process recipes. 

  • To coordinate with relevant departments, stakeholders in tracking of operation progression to ensure project milestones are met. 

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

  • Train and coach manufacturing team in process and equipment knowledge to ensure operations are conducted in a safe manner. 

  • Manage change controls and deviations of GMP runs for clinical manufacturing. 

  • 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. 

  

Requirement of Qualifications, Skills and Experience 

  • 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 in biological technology transfer will be an advantage. 

  • Experience/knowledge of cGMP practices applicable to upstream/downstream virus manufacturing processes, process development is desirable. 

  • Thorough knowledge of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP). 

  • Well-organized and detail-oriented, with ability to effectively prioritize tasks with agility, eager to learn, interact and collaborate effectively with various stakeholders in a team environment and consistently demonstrate reliability and responsibility. 

  • Good 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. 

Logo

Be part of Singapore's fastest growing Deep Tech Community

Receive the latest updates on ecosystem events and programmes!