OBJECTIVES:
- Act as user representative/area owner in terms of Cell culture process with full ownership of SOPs, protocols and forms.
- Commission first of its kind multiproduct cGMP manufacturing suites (mammalian, microbial suites) and transition to routine production while ensuring timely achievement of milestones.
- Perform hands on day-to-day 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.
- 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.
- 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.
- Perform basic 5S housekeeping.
- Any other duties as assigned by supervisor.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree in engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry) with more than 5 years of relevant industry experience.
- Plant start up or commissioning and/or operational experience in biologics and/or vaccines.
- Cell culture manufacturing experience required.
- Experience/knowledge of cGMP practices as applicable to upstream vaccines manufacturing processes, process development is desirable
- 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.
