Title:  Bioassay analyst

JOB DESCRIPTION

Job Title: Senior Executive IPQC

Job Location: Bangalore, Quality Control -Biologics

About Syngene :  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times

Core Purpose of the Role :

• Plate based and Bioassay analysis
• Operating in shift and ensuring release of Inprcoess/Finished product samples/Stability samples within TAT and by adhering to compliance norms.
• Ensuring the calibration of instruments and handling breakdown in coordination with vendor.
• Adhering to good laboratory and analytical procedures.

Role Accountabilities

• To handle the Plate based and cell-based Bioassay analytical techniques
• To handle the Inprocess and Finished products analysis in shifts
• To perform the analysis of Stability samples.
• To handle the calibration of QC instruments/Equipment.
• To ensure the completion of trainings allotted in time and support the team lead for achieving the deliverables.
• Adhere to the SOP/IOP and perform the analytical activities.
• Adhere to the good laboratory practice and compliance.
• Ensure error free analysis and documentation.
• Co-Ordinate with external vendors for ensuring timely calibration and PM activities.
• To ensure storage chambers are maintained at set temperature limits and take timely action in case of any excursions.
• To ensure the instrument/equipment are in calibrated state.
• Ensure the breakdowns if any are rectified in time and instrument is made up and running within shortest possible time in co-ordination with service provider.
• Ensuring all time audit readiness and preparation prior to audits.
• Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
• To support any other activity allotted by the team lead.

Leadership Capabilities

• Continuous Learning and Improvement
• Accountability and Integrity
• Collaboration with in the team
• Aggressive but assertive on task completion.
• Personal integrity and good attitude.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

Experience

3-6 years of experience in Biopharma manufacturing/testing/compliance/Quality control.

Skills and Capabilities

• Entry level Knowledge on Biologics Manufacturing and testing compliance requirements.
• Good communication
• Co-Operation with team leads.

Education

Bachelor/Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering

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.