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 utilization 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 and BPR

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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