The incumbent will be involved in day-to-day support in biologics and vaccine manufacturing operations by providing operation/maintenance input and facilitating decision making. He/She will 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. He/She will commission first of its kind multiproduct cGMP manufacturing suites (mammalian, microbial suites) within the project timeline and budget.
Responsibilities
Responsible for ensuring that the manufacturing activities are performed in accordance with EHS guidelines and a cGMP-compliant manner.
Provide inputs to operation and equipment in the tech transfer activities of new product/process.
Draft, author and/or provide inputs in documentations such as facility fit assessment, user requirements, raw material identification, batch records, SOPs, and process recipes.
To coordinate with relevant departments and stakeholders in the tracking of operation progression to ensure project milestones are met.
Perform and lead root cause analysis for operational related deviations and investigations using established problem-solving tools.
Train and coach manufacturing team in process and equipment knowledge 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.
Education, Behavioural Competencies And Skills
Bachelor’s degree in an engineering/scientific discipline (Bio/chemical engineering/life science/biology/chemistry) with 2-6 years of relevant industry experience.
Plant start-up or commissioning and/or operational experience in biologics and/or vaccines.
Biological technology transfer experience will be an advantage.
Experience/knowledge of cGMP practices applicable to upstream/downstream virus manufacturing processes, and process development is desirable.
Thorough knowledge of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (cGMP).
Well-organized and detail-oriented, with the 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.
Good team player with good working ethics, initiative, diplomacy, positive influencing abilities, and drive.
Good oral communication and demonstrate exemplary writing skills.
Experience in problem-solving and statistical tools will be an advantage.
