Specialist

Job Summary/ Main Purpose

Specialist - the role holder is responsible for the implementation of all Julphar’s procedures, and policies and assists the production department in complying with all regulations to increase effectiveness.

Responsible for the upstream operations in the Biotechnology Plant , ensure and monitor the smooth running daily activities of department. Must assess current procedures, track production data, manage schedules, maintain important documents, database, preparing reports, analyze performance, and communicating relevant information to department

Key Responsibilities & Key Result Areas

• Responsible to follow cGMP norms and the Standard Operating Procedures as defined.
• Supervise and oversee daily cell culture operations, ensuring adherence to protocols and timelines.
• Manage a team of technicians and Sr.Technicians  providing guidance and training on cell culture techniques.
• Plan and coordinate cell culture activities, including media preparation, cell growth monitoring, and bioreactor operations.
• Ensure compliance with safety, quality, and regulatory standards (e.g., GMP).
• Troubleshoot technical issues and optimize processes for improved efficiency and yield.
• 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.
• Responsible for &  cGMP document preparation.
• Perform QMS activity,deviation investigations, root cause analysis, and corrective action/preventative action (CAPA) implementation.
• 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 to prepare Standard Operating procedure (SOP) for related Plants and update on the same as required for any changes.
• Re-check and confirm the batch processes, details including Batch no., manufacturing and expiry date.
• Check and maintain all related logbooks and records.
• Use SAP to approve work orders, manage equipment and drive maintenance work practices.
• Generate SAP notification for calibration due or maintenance.
• Review MPI/MFMs for any required changes.
• Must work in close coordination with the department to gather in-depth understanding of the nature of their function to be able to provide the needed support to it.
• Preform any other work assigned by manager and support colleagues whenever necessary.).

Core Competency

• In terms of competency you are highly oriented with strong sense of accountability & ownership.
• High on compliance adherence, having strong implementation skills.
• Excellent communication, interpersonal, and collaboration skills
• Professional and should be able to juggle competing priorities.
• Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area goals.
• Must be able to multitask, task prioritize without guidance and easily adopt to changing situations.
• Ability to work effectively under pressure and meet established deadlines.

Qualifications / Key Experiences / Functional Knowledge Requirements

• Master degree in a relevant scientific or engineering field such as Biotechnology, Microbiology ,Biochemistry, and Chemical engineering required.
• 8 + years’ experience with mammalian cell culture production 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