Job Description
Job Summary/ Main Purpose
Technician – the role holder is responsible to adhere with the cGMP principles and to maintain them in an effective manner. Follow instructions, work with other department, and help ensure that all safety regulations are followed. Responsible for the upstream operations in the Biotechnology Plant.
Key Responsibilities & Key Result Areas
- Responsible to follow cGMP norms and the Standard Operating Procedures as defined.
- Responsible for doing all Cell culture production activities under supervision.
- Responsible for Monitor cell inoculation, growth, cell expansion for regular production activity.
- Operate and troubleshoot bioreactors and Roller bottle incubator and cell culture systems
- Responsible to work with standard scientific equipment as described for relevant process, Roller bottle incubators, CO2 incubators, biosafety cabinets, centrifuge, autoclaves, weighing balances, pH meter, refrigerators and freezers.
- Prepare buffers and solutions as per MFM / SOP.
- Fills the production batch records and to ensure the quality standards are met.
- Maintains and operates machinery used in batch manufacturing based on operating procedures.
- Responsible for checking the calibration of equipment and validity of stored materials.
- Responsible for filling the documents (MFM, Logbooks / attachments).
Core Competency
- Highly oriented with strong sense of accountability & ownership.
- High on Integrity, & overall compliance.
- Positive and approachable manner.
- Good communication and collaboration with team work.
- Good technical knowledge with implementation skills.
- Ability to accept change, and implement it precipitately.
- Ability to manage own task on time under supervisor, and commitment.
- Ability to work under pressure & meet attendance standards. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.
Qualifications / Key Experiences / Functional Knowledge Requirements
- Bachelor’s degree or diploma in a relevant scientific or engineering field such as Microbiology, Biotechnology, Biochemistry, and chemical engineering required.
- 3+ years’ experience with mammalian cell culture and purification experience
- Understanding of cGMP strongly preferred
- Ability to work with computer controlled systems and proficient with Microsoft Word, Excel, and PowerPoint
- Required Knowledge of Good Documentation and recording.
