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.
Provide day to day support in biologics and vaccine manufacturing operation by
providing operation/maintenance input and facilitate decision making.
Responsibilities:
Ensure that manufacturing activities are performed in accordance to EHS guidelines and in a cGMP-compliant manner.
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.
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.
Act as delegate to the manufacturing manager when necessary.
Education, Behavioural Competencies And Skills:
Bachelor 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.
Biological technology transfer experience will be an advantage.
Experience/knowledge of cGMP practices as applicable to upstream/downstream virus 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.
