Snr/Technical Operations Engineer (DP)

Hilleman Labs; Singapore; On-site; SGD 75,000 - 95,000; Full time

Job summary

Hilleman Labs is looking for a Tech Transfer Lead in Singapore to oversee the transfer of process technologies for vaccines and biologics. The role involves collaborating with multiple teams to ensure the success of tech transfer projects, providing expertise in GMP, and supporting external manufacturing activities.

The ideal candidate holds a BSc/MSc in a scientific discipline with 4-8 years of relevant experience in biological technology transfers. Critical skills include drug product formulation, aseptic filling processes, and strong problem-solving abilities.

Qualifications

• 4-8 years relevant industry experience in biological technology.
• Experience in tech transfer of viral vector vaccines and mRNA processes.
• Knowledge of cGMP practices in vaccine manufacturing.

Responsibilities

• Lead tech transfer of vaccine processes from R&D to manufacturing.
• Collaborate with teams to meet tech transfer schedules.
• Provide oversight in external manufacturing contracts.

Skills

Technical transfer

Drug product formulation

Aseptic filling

Problem-solving

Good Documentation Practices

Education

BSc/MSc in engineering/scientific discipline

Job description

Reports to : Senior Manager, Technical Services & Validation

Objectives:

• Act as tech transfer lead for process technology transfers from R&D, CMC or external collaborators to and from GMP clinical manufacturing of different modalities and platforms to meet tech transfer objectives
• Provide supports in biologics and vaccine plant start up of a start-of-the-art fill&finish manufacturing facility and operation by providing technical/SME input, audit, investigation and CAPA
• Collaborate closely with key stakeholders within GMP clinical manufacturing such as Operations (Drug Product), Engineering, Validation, QA in meeting program /tech transfer schedule
• Support as process/area owner during manufacturing scale up, optimization of drug product formulation and filling facility readiness
• Provide external contract manufacturing oversight in technical operations to achieve project deliverables and timeline

Responsibilities:

• Lead/support tech transfer of process/product (vaccine preferred) with different modalities/platform from internal stakeholders and to/from external manufacturing partners in terms of tech-ops support such as deviations, change control and process input
• Experience with drug product formulation, aseptic filling of various formats such as liquid and lyophilized (freeze-dried), stoppering, capping, labelling and packaging, CCIT
• Provide external manufacturing support as part of tech transfer oversight
• Work and coordinate with different sub teams during tech transfer of drug product to ensure their timely involvement and alignment to the strategy and successful completion according to tech transfer schedule and deliverables.
• Act as Subject Matter Expert (SME) in fill & finish equipment, including but not limited to grade A isolator system with glove technology, VHP decontamination/ sterilistation, manual/cleaning validation/verification, machinability evaluation
• Act as SME in supporting users for water run, engineering run and media runs and aseptic medial fill and process simulation.
• Perform product/process root cause analysis for complex deviations and investigations using established problem-solving tools
• Mentoring operations crew in process and equipment knowledge and know-how to operate equipment as per design intent and troubleshoot operational issues
• Provide impact assessment and support to change control and deviations of GMP runs during clinical manufacturing
• Perform risk assessment related to process, engineering and safety (ie FMEA)
• Perform gap/risk assessment in terms of raw materials and consumables
• Support standard operating procedures (SOP) generation for process/equipment
• Support Audit as technology transfer SME where required
• Act as a training/document coordinator for the department
• Support cross-functional team such as validation related activities if required
• Act as a delegate to the Supervisors/Managers and conduct team activities in their absence

Education, Behavioural Competencies And Skills:

• BSc/MSc in an engineering/scientific discipline (Bio/chemical engineering/mechanical/life science/biology/chemistry) with 4-8 years relevant industry experience
• Biological technology transfer experience required in various modalities such as viral vector vaccines, biologics, mRNA process and LNP formulation
• Experience/knowledge of cGMP practices as applicable to upstream/downstream vaccine manufacturing processes, process development is desirable
• A thorough knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) and knowledge in guidelines and requirements from health authorities/regulatory bodies
• 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
• Must be a 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