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
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Responsible for ensuring that the manufacturing activities are performed in accordance with EHS guidelines and in a cGMP-compliant manner.
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Provide input to operation and equipment in the tech transfer activities of new product/process.
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Draft, author and/or provide inputs in documentations such as facility fit assessment, user requirements, raw material identification, batch records, SOPs, and process recipes.
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To coordinate with relevant departments, stakeholders in tracking of operation progression to ensure project milestones are met.
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Perform and lead root cause analysis for operational related deviations and investigations using established problem-solving tools.
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Train and coach manufacturing team in process and equipment knowledge to ensure operations are conducted in a safe manner.
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Manage change controls and deviations of GMP runs for clinical manufacturing.
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Support process/equipment qualification/validation activities and studies.
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Front auditors during regulatory audits as the SMEs of the department.
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Perform cleaning of equipment and cleanrooms as and when necessary.
Requirement of Qualifications, Skills and Experience
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Master’s degree in an engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry), with 2-6 years relevant industry experience.
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Plant start-up or commissioning and/or operational experience in biologics and/or vaccines.
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Experience in biological technology transfer will be an advantage.
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Experience/knowledge of cGMP practices applicable to upstream/downstream virus manufacturing processes, process development is desirable.
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Thorough knowledge of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
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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.
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Good team player with good working ethics, initiative, diplomacy, positive influencing abilities and drive.
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Good oral communication and demonstrable, exemplary writing skills.
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Experience with problem solving and statistical tools will be an advantage.
