Analytical Development Bilogics

JOB DESCRIPTION

Job Title: Analytical Development Biologics

Job Location: Bangalore

Department: Biopharmaceutical Development

About Syngene: Syngene () 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

• Develop qualify implement and transfer new analytical methods from RND to quality control manufacturing groups and others
• Handling samples from upstream/downstream/formulation/quality control/production for analysis using analytical methods
• Data Analysis - Includes data generation collation and interpretation following established quality systems.
• Preparation of analysis reports
• Regular documentation of experiments contemporaneously in electronic lab notebook.
• Compilation of experimental data for further evaluation.
• Authoring technical reports and communicating the key findings.
• Participating in the weekly team meetings.
• Work closely with cross functional teams and contribute to knowledge sharing best practices and continuous improvement initiatives.
• Ensuring adherence to 5S guidelines in the lab area.
• Supporting in breakdown management of downstream equipment and serve as point of contact to ensure smooth functioning of instruments.
• Enable the team in procurement of raw materials and consumables and in lab maintenance and remove any obstacle in maintaining lab inventories.
• Actively participate in quality related investigations and propose effective corrective and preventive actions.
• Ensure compliance in issuance of lab notebooks and archival of records such as logbooks lab notebooks protocols reports documents in electronic management system.
• Well versed with TrackWise or similar QMS systems

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

Extensive experience with analytical methods - LC CE and methods for process impurities and excipient analysis for mAbs. The candidate should have thorough technical knowledge of analytical methods typically used for mAbs analysis.

Experience being a team lead

Experience with method development validation and transfer to QC.

Good communication skills and is a team player

Skills and Capabilities

• Should be experienced in analytical methods to independently perform daily activities and guide a sub-team to achieve deliverables.
• Should be a good team player.
• Experience in using electronic lab notebook Electronic Database Management System (EDMS) TrackWise is preferable not mandatory.

Education

• Masters degree in Life Science Chemical Engineering Biotechnology or related field.

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.