Manufacturing Biotechnologist

2 weeks ago

Singapore Hilleman Laboratories Singapore Pte Ltd Full time

**Objectives**:
The incumbent will be involved in day-to-day support in biologics and vaccine manufacturing operations by providing operation/maintenance input and facilitating 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 first of its kind multiproduct cGMP manufacturing suites (mammalian, microbial suites) within the project timeline and budget.

**Responsibilities**:

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

**Education, Behavioural Competencies And Skills**:

- Bachelor’s degree in an engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry) with 2-6 years of relevant industry experience.
- Plant start-up or commissioning and/or operational experience in biologics and/or vaccines.
- Biological technology transfer experience will be an advantage.
- Experience/knowledge of cGMP practices applicable to upstream/downstream virus manufacturing processes, and process development is desirable.
- Thorough knowledge of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
- Well-organized and detail-oriented, with the 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 demonstrate exemplary writing skills.
- Experience in problem-solving and statistical tools will be an advantage.

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