Process Engineer, Drug Substance

5 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

  • Bioconjugation & Purification Engineer (GMP Drug Substance)

    5 days ago

    Singapore WuXi XDC Full time

    A leading biopharmaceutical company in Singapore is seeking experienced professionals to perform bioconjugation reactions and purification of drug substances. The ideal candidate will have a diploma or degree in a relevant field with 3-5 years of experience, along with strong communication and methodical work habits. This role requires adaptability to a GMP...

  • Forensic Scientist, Illicit Drugs Laboratory

    3 days ago

    Singapore Health Sciences Authority Full time

    **What the role is** - You will be working with a team of Scientists and supervise a team of Laboratory Officers to provide quality and efficient forensic testing of seized drug exhibits. You will also be in-charge of R&D projects and participate in quality assurance activities. **What you will be working on** - Job Description: - Forensic examination and...

  • Process Engineering Lead

    2 weeks ago

    Singapore WuXi Biologics Full time

    Process Engineering Lead (Including operation and maintenance of Clean Utilities)Lead a team of engineers and technicians in managing maintenance and calibration of aseptic Drug Product and Drug Substance facilities. Lead the team in maintaining Drug Product aseptic clean room, vials, pre-filled syringes lines, vials lines with lyophilizer, automatic...

  • Process Development Senior Engineer

    1 week ago

    Singapore Amgen Inc. (IR) Full time

    ## **Career Category**Process Development## ## **Job Description****Process Development Senior Engineer****Amgen Singapore Manufacturing**Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has...

  • Process Development Senior Engineer

    1 week ago

    Singapore Amgen SA Full time

    Overview Process Development Senior Engineer Amgen Singapore Manufacturing HOW MIGHT YOU DEFY IMAGINATION?Amgen is one of the world's leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed...

  • Process equipment engineer

    5 days ago

    Singapore WuXi XDC Full time

    KEY ACCOUNTABILITIES: Process equipment engineer is responsible for support and coordination of Process Equipment installation, testing and commissioning of process equipment together with project team during the construction phase., and leading maintenance activity in operation phase. you are required to manage maintenance and renovation works in the fields...

  • Manufacturing Engineer

    3 days ago

    Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time

    **Responsibilities** - Bioconjugation Reactions and Purification of Antibody Intermediates and Conjugated Drug Substances - Perform downstream protein purification manufacturing operations for drug substances under the guidance of SOPs. This includes, but is not limited to, chromatography system operation, conjugation, low pH viral inactivation,...

  • Associate Manufacturing Engineer

    5 days ago

    Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time

    Responsibilities Bioconjugation Reactions and Purification of Antibody Intermediates and Conjugated Drug Substances Perform downstream protein purification manufacturing operations for drug substances under the guidance of SOPs. This includes, but is not limited to, chromatography system operation, conjugation, low pH viral inactivation, nanofiltration,...

  • Forensic Scientist, Illicit Drugs Lab

    5 days ago

    Singapore HSA Health Sciences Authority Full time

    You will be working with a team of Scientists and supervise a team oF Laboratory Officers to provide quality and efficient forensic testing of seized drug exhibits. You will also be in-charge of R&D projects and participate in quality assurance activities. - Forensic examination and analysis of seized drug exhibits, reviewing and reporting of test results...

  • Manufacturing Engineer

    2 weeks ago

    Singapore WUXI XDC SINGAPORE PRIVATE LIMITED Full time $80,000 - $120,000 per year

    ResponsibilitiesBioconjugation Reactions and Purification of Antibody Intermediates and Conjugated Drug SubstancesPerform downstream protein purification manufacturing operations for drug substances under the guidance of SOPs. This includes, but is not limited to, chromatography system operation, conjugation, low pH viral inactivation, nanofiltration,...