apply now Principal Scientist- DMPK-Invivo Pharmacokinetics

Job Description

Job Title: Principal Scientist Invivo Pharmacokinetics Job Location: Bangalore Reporting to: Lead Scientist Job Grade: 6-I 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.
Core Purpose of the Role: To conduct In vivo pharmacokinetics study in rodents. Ability to adapt to the dynamic team environment. Role Accountabilities:
• Conduct of pharmacokinetic studies in rodents.
• Preparation of study protocols, reports for IND/ NDA submissions.
• Documenting the lab notebooks online and compound management.
• Ability to adapt to the dynamic team environment.
• Possess the knowledge and exposure to environment, health, and safety (EHS) practices
• 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.
• Ensuring that there are no safety non-compliances in areas that my team operates in.
• Ensuring adherence to all Syngene policies related to data integrity by all members of the team including self
• Ensuring all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Reporting incidents (or near-misses) and learnings from those incidents to avoid recurrence.
• Compliance to Syngene s quality standards at all times and ensuring the same by the team members.
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time
Syngene Values: All employees with consistently demonstrate alignment with our core values
• Excellence
• Integrity
• Professionalism
Accountabilities as a Syngene Leader:
• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.
• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.
Experience: 10 years post qualification Technical/functional Skills:
• Well versed with surgical procedures like cannulation of jugular, femoral, portal vein in rats. Chronic bile duct cannulations in rat and various animal models used for in vivo pharmacokinetics studies.
• Collection of different vital organs during tissue distribution studies in rodents
• Pharmacokinetic data analysis using Phoenix WinNonlin and other data analysis tool.
• Collection of various biological fluids like cerebrospinal fluid, bile, urine, synovial fluid lavage during PK and tissue distribution studies in rodents.
• Should have preliminary understanding about formulations to be used for pharmacokinetics, efficacy and toxicity studies.
• Knowledge about regulatory guidelines followed for drug metabolism and pharmacokinetics is desirable.
Behavioral Skills:
• Should be well versed in verbal and written communication, should be a team player.
• Should be focused towards results and deliverables.
• Should have a high moral framework (ethics code) and high data integrity sense.
Educational Qualification: Ph.D 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.,

Keyskills :
animal modelsdata integrityoccupational healthhplcresearchapidata analysisin vivo