Team Leader - Bioassay

JOB DESCRIPTION

Job Title: Team Leader - Bioassay

Job Location: Bangalore, Biocon Park

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:

• Responsible for Plate Based and Bioassay analytical lab operations
• To lead the team of about 10 personnel
• To Handle day to day QC operations and shift operations
• Delivery of Commercial batches release on time in compliance to applicable guidelines
• Delivery of early phase products/new product on time with client satisfaction  
• Leading method transfer and validations, specifically Bioassay and Molecular Biology analytical techniques
• Overall responsible for compliance of the laboratory
• Responsible for handling regulatory audits
• Responsible for audit response, CAPA and implementation
• Facilitating the availability of testing procedures and ensuring batch release in time
•  Handling client calls and facilitating client requirements
• Handling product audits
• Providing the Quality matrix to the management
• Identify potential risks with QC operations and inform management on timely manner, take necessary steps to mitigate the risk
• Ensuring all time audit readiness and preparation prior to audits.
• Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
• Responsible for computer system validation and instrument qualifications
• Builds robust plan to deliver outcomes
• Work well across functions and Demonstrates courage when under pressure
• To support any other activity allotted by the Quality Control Head

Role Accountabilities:

• End to End Molecular Biology and Bioassay operations
• People Management
• Quality Risk management
• Audits and compliance
• Deliveries

Syngene Values

 All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

 Specific requirements for this role

1. Experience: Expert
2. Demonstrated Capability-

1. Good Knowledge on Biologics Manufacturing and testing compliance requirements.
2. Good communication
3. Co-Operation with CFT

3. Education - M. Sc. or any equivalent  

 Skills and Capabilities:

• People management
• Quality risk management
• Audit management
• Client Management
• Customer centricity
• Simplification of procedures

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.