Title:  Associate manager

Designation: Associate Manager

Job Location: Bangalore

Reporting to: Deputy Manager

Job Grade: 7-I

Role-specific:

• Ensure there is no safety or environmental non-compliance in all areas that your staff work in.
• Ensure adherence to all policies related to data integrity by all members of the team including self.
• Responsible for the safety of self & team by ensuring all necessary safety procedures and policies are followed.
• Follow Environment, Health, Safety and Sustainability (EHSS) requirements always at the workplace to ensure individual and plant safety.
• Ensure that all assigned mandatory training related to data integrity, health, and safety measures is completed on time by all team members, including self.
• Communication of incidents (or near-misses) and learnings from those to ensure such an incident is not repeated/does not happen.
• Support in the hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
• Reporting of non-conformities and implementation of corrective/ preventive actions for manufacturing process and facility.
• Ensure that deviations and CAPAs are addressed right the first time and monitor the health of manufacturing quality systems.
• Preparation, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Records (PDR).
• Issue, Checking and Review of Operations documents.
• Preparation and review of SOPs, EOPs, IOPs, Protocols and reports.
• Review of TTDs and accordingly check facility fitment.
• Investigation of Batch failures in Operations.
• Develop and train high-potential candidates for the next generation of leaders. Serve as a mentor to develop other department leaders.
• Monitor and follow good aseptic behaviour inside the BMP1 Facility.
• Perform all the Downstream activities, such as assembly preparation, accessory arrangement for each step, ensuring raw materials and consumables are dispensed and available before operation, reconciliation of excess and unused raw materials and consumables, Buffer Preparation, Harvest Clarification, Chromatography operation, Low pH and Intermediate depth filtration, Viral filtration, TFF Operation, and 0.2 µ filtration.
• Operating and cleaning of downstream equipment(s) as per standard operating procedures and EOP.
• Monitoring and process control of the specific Operations of the Downstream.
• Perform room owner responsibility for the assigned DSP area.
• Perform equipment/instrument ownership-related responsibilities related to DSP.
• Initiate Complaint Slips (work orders) for DSP-related areas and equipment.
• Coordinate with QA for line clearance.
• Maintaining process area All-time ready for Inspection/audit purposes.
• Maintain the facility and assigned zone at all times, ready for visits and audits. Participate in clients', internal, and regulatory audits. 
• Perform error-free operations as per the Batch Manufacturing Record (BMR) by meeting cGMP and GDP requirements.
• Involve in shipment of samples / final product as per packing and dispatch record.
• Work proactively to meet all document(s) on-time closure requirements. Ensure supervisory review and stage-wise reconciliation are completed on the floor and updated in the BMR.  
• Execute the protocols related to downstream-related activity and equipment/instrument qualification.
• Involve in Shipment of samples /final product as per packing and dispatch record
• Track the work order status and ensure timely closure.
• Involve in the implementation of electronic batch manufacturing records. 
• Do review in track-wise and EDMS system. 
• Should be good at Communication Skills, Teamwork and Collaboration, Adaptability, Problem-Solving Skills, Emotional Intelligence etc. 

Education and Experience

Education

Master’s degree in Biotechnology, Microbiology or relevant field, M. tech. 

Industry Experience

Minimum 10 - 13 years of downstream manufacturing experience, and people manager experience.

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Pls visit us at https://syngeneintl.com/ to know more about us and what we do.