Process Engineer, Drug Substance

6 days ago

Singapore Takeda Pharmaceutical Full time

**OBJECTIVES**:
Responsible for planning and supporting the Dengue Drug Substance Process Technology Transfer from Takeda to Contract Manufacturing Organization (CMO) in India. Includes document/knowledge transfer activities, process design and improvements, process scale-up, GMP Production, and validation aspect of the manufacturing. Involved in developing Technical Operations documents, including the establishment Technology Transfer Protocols, Risk Assessment, Comparability protocols, etc, in support of the main Technology Transfer activity. Review of CMOs documents such as Studies protocol, SOPs, Batch Records, Deviation and Change Control, etc. Close Collaboration with internal and external stakeholders to ensure projects are conducted to an appropriate standard and in timely manner.

**ACCOUNTABILITIES**:
Overseeing Takeda Drug Substance manufacturing activities at the CMO, acting as Person-In-Plant, as process owner in the CMO facility. Responsible for ownership and completion of Batch Record / Study Reports review, Change Controls, investigations, and CAPAs arising from manufacturing runs executed at CMO. Participate in the Technical discussions and activities with global team for Takeda’s Vaccines Drug Substances Transfer to CMOs.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:
Bachelor degree (with relevant experience) or MSc in life sciences or closely related field At least 2 years of applicable experience (4 years for senior position). Experience in Biologics process (Drug Substance) development and/or manufacturing environment is required. Knowledge in vaccines manufacturing process would be an advantage. Experience in Cell Culture (Attachment Cell lines) would also be an advantage. A thorough knowledge and experience of Good Documentation Practices (cGDP) and cGMP. Experience in writing/review/approval of technical documents, including validation documents, Risk Assessment, protocols and reports, etc. Experience in Validation strategy and implementation in GMP manufacturing facilities. Familiar with Quality Management System aspect/implementation in Manufacturing Facility. Well organized and detail oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility. Knowledge of statistical analysis for biological systems (non-clinical stats) and Design of Experiments (DoE) as applied in an industrial biopharmaceutical environment will be a distinct advantage Team player with strong initiative & drive Strong verbal and written communication skills, diplomacy and positive influencing abilities Comply with Takeda safety practices and standard operating procedures.

**PHYSICAL DEMANDS**:

- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical manufacturing floor activities: bending, stooping, lifting requirements apply.
- Lifting and moving supplies and equipment (up to 50 pounds).
- Working and collaboration globally, occasion out-of-office hour meeting and discussion required.

**TRAVEL REQUIREMENTS**:

- Willingness to travel to various meetings (International travel) and manufacturing visit to CMO site (In India). Approximately 20 to 30% of working period.

**Locations**:
Singapore, Singapore

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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