Associate Scientist-BioAnalytical

Job Title: Associate Scientist - BioAnalytical 

Job Location: Syngene International Limited, Bengaluru

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
Hold self and their teams accountable for the achievement of safety goals
Govern and Review safety metrics from time to time

Role Accountabilities:

Responsibilities as Document Controller in GLP System.

Ensure compliance with the requirements of GLP, ISO/IEC 17025, OECD or other required regulatory guidelines.
Responsible for the management of documents.
Distribution of MOAs and Formats.
Issuance of MOA numbers, Logbooks number, Validation document number and Spreadsheet numbers etc., related to GLP functions.
Issuance and reconciliation of Study related recording formats and facility related recording formats, SOPs as applicable.
Issuance of validated Microsoft Excel spreadsheets
Maintain a list of Specimen Signatures, List of GLP Personnel in consultation with HODs.
Preparation and update log of MOA index, log of logbook index.
Uploading Study related, facility documents and general recording formats, as applicable in Syngconnect.
Updating of SAP and ERP.
Archiving master copies of MOAs.
Archiving facility related documents.
Assigning training on LMS for employees to ensure compliance.
Preparation of SOP’s / Formats, as applicable.
Engage in vendor evaluations to ensure alignment with quality, regulatory and technical standards
Ensure optimal performance of laboratory equipment by establishing and adhering to GLP standards, quality control procedures, and troubleshooting protocols. Oversee instrument qualification, certification, and compliance, and manage equipment servicing, repair, and replacement
Responsible in supporting clinical sample management including shipment tracking, ensuring compliance with study protocols. Maintain accurate inventory and support cross-functional team for timely sample handling, Communicating with sponsors, SDs and Sample custodian for uninterrupted execution

Other Responsibilities:

Any other responsibility assigned by GLP-Management.
Updating of equipment calibration details in ELN
Responsible to comply with regulatory requirements of facility.

Syngene Values:

All employees will consistently demonstrate alignment with our core values

 Excellence
 Integrity
 Professionalism

Specific requirements for this role

Experience
Demonstrated Capability
Education

Experience:
Looking for an entry level lateral from science background.

Education:

Ph.D., in Biotechnology with thorough knowledge in vector design, protein expression and cell line 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.