QC Bioassay analyst

JOB DESCRIPTION

Job Title: QC Bioassay Analyst

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

Core Purpose of the Role:

This is an exciting opportunity to play a role in Bioassay analyst in the Quality Control Biologics Lab at Sygene International Limited. The role will provide exposure to bring in newer technologies and improve the workflow in terms of executing routine testing and validation of plate based methods (like ELISA) and Cell based potency method (Luciferase assay, reporter gene assay, Inhibition of proliferation assays etc.).

Role Accountabilities

- Responsible for preparation of documents such as Standard Operating Procedures (SOP), Instrument/Equipment Operating Procedures (IOP/EOP) etc.

- Preparation of batch release documents like specifications, Standard Test Procedures with observation data sheet, verification protocols, method transfer protocols etc.

- Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product and stability testing.

- Responsible for involvement and participation during the preparation and general laboratory readiness for the internal / external / client audits.

- Responsible to complete all planned quality & compliance training as and when required by the department / section or asked by the HOD / Section Head.

- To prepare the complete list of materials (CLM) required for various project.

- Responsible to initiate and inform immediately to department HOD/designee, if there are any laboratory incidents, deviations, change controls and out of specification results were observed.

- Responsible to conduct any job assigned by the superior.

- Responsible for the training coordinator activity which includes providing of training questionnaire, submitting the GTR to archival QA, preparation of JD, training matrix, training binder, review of training files and assigning training in LMS.

- Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.

- Responsible for the preparation of stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study.

- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.

- Attend training on environment, health, and safety (EHS) measures imparted company.

Syngene Values

All employees will consistently demonstrate alignment with our core values

- Excellence

- Integrity

- Professionalism

Specific requirements for this role

Experience: 3 -6 years

Technical Skills and Capabilities

- Planning and execution of Bioassay and Binding ELISA analysis for Biologics of drug substances / finished product.

- Planning and execution of Plate based methods like Host Cell Protein, Residual Protein A, Host Cell DNA by RT-PCR.

- Assistance in setup up of bioassay lab as per the direction of Supervisor/Section Head.

- Preparation of documentation such as SOPs, IOPs, EOPs etc.

- Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.

- Responsible for performing the method transfer analysis and verification activity with documentation for the samples of in-process/finished product.

- Ample Knowledge on LIMS.

- Good knowledge on Quality Management Systems (Laboratory Incidents, OOS Reporting, OOT reporting, Change Management, Analytical Method Lifecycle).

- Advanced understanding on Excel spreadsheets

Behavioral skills

- Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.

- Good interpersonal skills and communication skills

- Good speaking-listening-writing skills, attention to details, proactive self-starter.

- Ability to work successfully in a dynamic environment.

- Ability to plan own work, react to change in priorities based on business need and workloads.

- Ability to develop new ideas and creative solutions.

- Should contribute as a team player by providing ideas for continuous improvement, simplify work and documents, and also have operational excellence mindset.

- Should be flexible to work in shifts.

Education: Masters in life sciences (Biochemistry or biotechnology)

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.