Job Responsibilities:
In charge of making sure that GLP toxicity studies—both acute and repeat dose—are completed in accordance with global regulatory guidelines [ICH/OECD] and the necessary scientific and regulatory requirements.
Serve as a single point of contact for all matters pertaining to the control of research, including scientific, technical, and regulatory aspects as well as scientific interpretation, recording, and reporting of findings.
With some supervision from the direct manager and senior members of the organization, design, plan, and monitor various GLP toxicity studies, biocompatibility studies, risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents, and excipients), and safety data sheet related activity.
In compliance with ICH and ISO10993-17, create toxicological risk assessment reports and, as a subject matter expert (SME), review or concur with toxicology assessment reports.
Evaluate the risks associated with chemicals and pesticides used in production on your own.
Engage in key technical team meetings as a representative for preclinical/toxicology, offer your expertise, take the lead on tasks, and ensure that projects are completed with efficient teamwork and deliverables.
To evaluate toxicological endpoints, use in silico tools (e.g., Lhasa Derek and Sarah Nexus software).
Prepare and/or review the safety data sheets (SDS), PBRER sections, and nonclinical eCTD.
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
Skills:
Shown proficiency in oral and written communication as well as presentation abilities to international stakeholders, proficiency in the language.
Able to interact with clients both inside and outside the company.
Good documentation practices, email, and collaborative platforms like Teams, Zoom, Microsoft Office products, etc. are examples of strong computer abilities.
Proven capacity to operate in a matrix setting with several stakeholders
Demonstrates adaptability and the ease with which one can switch between projects.
A track record of achieving results by taking responsibility for the project's budget, schedule, and deliverables.
Preparation of study plan considering the client requirements as well as regulatory requirements.
Preparing a study schedule and communicating with all the study personnel and ensuring the proper conduct of the study.
Preparing reports after completion of each study. This involves evaluating the data output by applying scientific knowledge and skills.
To maintain the highest regulatory standards (GLP and AAALAC recommendations) during any activity conducted in the facility by continuous monitoring and checkup of all the instruments/equipment used in a study as per Standard Operating Procedures (SOPs).
Preparation and periodic revision of Standard Operating Procedures.
Preparation and presentation of experiment conduct protocols to the Institutional Animal Ethics committee.
Periodically verify data generated during study.
Archival of the study plan, study report, raw data and related materials as per the study plan.
Coordinate with Principal Investigators and/or study personnel in case of multi-site studies keeping informed of their findings during the study and receipt and evaluation of their respective individual reports for inclusion in the final study report.
Interested candidates can mail their CVs to minakhi.bhowmick@syngeneintl.com
Job link: https://career10.successfactors.com/sfcareer/jobreqcareer?jobId=55415&company=syngeneP1
Syngene is a contract research, development, and manufacturing organization (CRDMO) that offers integrated manufacturing, research, and development services to firms in the agrochemical, biotechnology, pharmaceutical, and animal healthcare sectors. World industry leaders comprise Syngene's clientele, including small and medium-sized start-ups, government agencies, non-profits, and academic institutions.
Listed separately on the NSE and BSE Indian stock exchanges, Syngene was founded in 1993. Syngene works for clients worldwide, producing innovation that improves human and animal health. The company has a distinctive business strategy, a talent pool of over 6000 scientists, scientific knowledge across novel therapeutic modalities, an experienced management team, and an independent Board committee. Syngene serves as a strategic partner to its clients, frequently functioning as an extension of their internal scientific teams, and provides creative, adaptable, and effective methods for quickly scaling up. Faster access to patients and go-to-market are thus made possible by this.
Syngene is adamant about striking a balance between corporate expansion and environmental responsibility. The four main pillars of its ecological, social, and governance (ESG) strategy are controlling its environmental impact, upholding solid governance, investing in local communities, and being a responsible employer. According to this plan, Syngene recycled 20% of its water, 86% of its energy came from renewable sources, and it saved 1.99 million KWh of energy through operational efficiency. It also recycled 92% of its hazardous and non-hazardous trash (see the ESG report).