OBJECTIVES:
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.
Perform manufacturing and maintenance activities to ensure that critical manufacturing operations are on track and within budget.
RESPONSIBILITIES:
- Execute manufacturing activities in a safe and compliant manner.
- Ensure data is recorded in an ALCOA manner in the Manufacturing Batch Records (MBRs) and forms.
- Provide input to operation and equipment in the tech transfer activities of new product/process.
- Draft, author and/or provide inputs in documents consisting of but not limited to, facility fit assessment, user requirements, raw material identification, batch records, SOPs and process recipes.
- Perform front line troubleshooting of Fill finish equipment.
- Be part of the Total Productive Maintenance for Fill finish equipment.
- Coordinate with relevant departments and stakeholders and track progress of operation to ensure project milestones are met.
- Perform and lead root cause analysis for operational related deviations and investigations using established problem-solving tools.
- Complete required training on time to ensure operations are conducted in a safe manner.
- 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.
- Perform basic 5S housekeeping.
- Any other duties as assigned by supervisor.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree in a engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry) with 2-6 years relevant industry experience.
- Plant start up or commissioning and/or operational experience in biologics and/or vaccines.
- Experience/knowledge of cGMP practices as applicable to fill finish processes is required.
- A thorough knowledge of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
- 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.
