Job Description

Posted Date :


15 Nov 2024
Function/Business Area :


Life Sciences
Location :


DALC - Navi Mumbai
Job Responsibilities :


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To ensure manufacturing as per SOP and timely completion of projects.

1)Plan & Execution of product manufacturing :


To facilitate Operation & changeover of process systems, debottlenecking of process hurdles


Regular interaction with Operation team, QAD and supporting functions to achieve the desired targets


Focus on plant goals in order to attain expected products over all batch yield


Coordinate and monitor the manufacturing schedule to ensure proper utilisation of process units, utilities etc.


Hands on experience with bioreactors ,chromatography,TFF,CIP systems


Exposure on DCS control system would be preferable


Scale up, scale down processing of both upstream and downstream process


Upstream processing operations # seed bioreactors ,production bioreactors operations ,media and buffer preparation activities


Downstream processing operations # Centrifugation, Microfiltration and Ultrafiltration skid systems.


2) Review & monitoring :


To ensure the preparation of the cleaning / disinfectant solution and cleaning/fumigation of area/equipment as per the schedule and respective SOPs.


To ensure entire manufacturing activities to be performed as per respective SOP's /guidelines


To ensure that on- line entries in GMP documents like BMRs, BPRs, log-books etc. are performed as per Good Documentation Practice.


To ensure that all documents are updated/revised periodically to meet cGMP standards and as per QAD requirement


Ability to mainly evaluate schedule in accordance to manufacturing processes, and determine the most efficient method of accomplishing goals in order to meet the targets.


Supervise, coach and train new and current employees (i.e. job, safety, etc.) to meet performance expectations by providing strong leadership skill set.


3) GMP compliance, Validation and audit readiness


To co-ordinate and support for timely completion of calibration, preventive maintenance, qualification/ validation revalidation of process units as per schedule.


Ensure that safety, Good Manufacturing Practices (GMPs) and sanitation policies and procedures are met.


Process systems and manufacturing area readiness for GMP.FDA,WHO and international audits


Preparation of BMR#s and BPR#s


Validation protocols preparation and its execution




Education Requirement :


• Graduate or Post graduate in Science, B.E in biotech engineering


Experience Requirement :


• Having minimum 0-1 years# experience.
• Demonstrated ability to effectively supervise, lead and build relationships at all levels within the company.




Skills & Competencies :


Safety Requirements:


Carrying out activities related to Occupational Health, Safety and Environment Management as per SOP


Awareness/Knowledge on the consequences of not following Standard Operating Procedures related to Occupational Health, Safety and Environment Management



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