Study Director - Immunogenicity Research Laboratory

Job Title: Lead Scientist - Bioanalytical

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.

Core Purpose of the Role:

Responsibilities as Study Personnel in GLP System.

1. Method Development for Immunogenicity, Pharmacodynamics, Pharmacokinetics assessment using ligand binding assays and characterization of novel biologics and biosimilar products using Surface Plasmon Resonance technology (SPR), while conducting experiments and ensuring accurate documentation and compilation of data.

2. Method Validation for Immunogenicity, Pharmacodynamics, Pharmacokinetics assessment using ligand binding assays and characterization of novel biologics and biosimilar products using surface plasmon resonance technology (SPR), while performing validation activities and ensuring accurate documentation and compilation of data.

3. Samples Analysis for Immunogenicity, Pharmacodynamics, Pharmacokinetics assessment using ligand binding assays and characterization of novel biologics and biosimilar products using surface plasmon resonance technology (SPR), also conducting sample analysis and ensuring accurate documentation and compilation of data.

4. Responsible for complying with instructions given in the Study Plan and SOP.

5. Should be trained on Study Plan, amendments if any, and all applicable Study related SOPs before initiating any study activity.

6. Responsible for recording raw data in compliance with the Principles of GLP and is responsible for quality of recorded data.

7. Should compile all communications pertaining to the Study as appropriate.

8. Should document all deviations from the approved SOPs/ Study plan and communicate directly to the SD/PI in a timely manner.

9. Should follow laboratory safety and waste management procedure as per approved SOPs applicable to the area.

10. Should communicate to the SD/TFM, any relevant known health or medical condition in order to be excluded from operations that may affect the Study.

11. Should communicate effectively on progress of the Study to SD/PI.

12. Should follow SD/PI decision for any stage that affects the integrity of the study data.

Other Responsibilities:

1. Preparing Standard Operating Procedures related to the experiment.

2. Maintaining all assay record/Lab note books/usage log books.

3. Ensuring all documentation needs as per the Bioanalytical Laboratory GLP requirements.

4. Recording facility related activities in relevant log books and formats.

5. Preparation of equipment qualification documents as applicable.

6. Assisting additional work of Bioanalytical Laboratory whenever entrusted.

7. To ensure all the above responsibilities are also performed for Non GLP studies as well.

8. Any other responsibility assigned by the Management.

Syngene Values:

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience:

Mid level lateral with experience in immunoassay laboratory. (CRO experience is preferable).

Education:

Master's degree in Biological Sciences (Preferably Biochemistry background) or a 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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.