About this role
Designation: Director - In Vitro ADME, MET-ID
Job Location: Bangalore
Department: Discovery Biology
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
Job Purpose
- Lead the In vitro ADME and Biotransformation group within DMPK function
- Work as a DMPK project leader for the Integrated Drug Discovery project
Key Responsibilities:
- Extensive experience in designing and interpreting data from In vitro ADME assays from various projects. Demonstrated experience in designing mechanistic ADME studies to understand the potential issues / liabilities associated with the new chemical entities.
- Lead various Integrated Drug Discovery projects of various therapeutic areas for identification of drugability issues early in the program and help the team to identify and select clinical candidates.
- Represent the department in multidisciplinary /cross functional team meetings
- Ensure generation of scientifically robust and high-quality data within project timelines.
- Setting up KRA / KPI for the team members and monitoring their performance.
- Drive laboratory efficiency, productivity, and resource utilization.
- Interaction with cross functional team for smooth functioning of various assays/ studies
- Responsible for compliance related to the electronic lab notebooks, SOPs.
- Seamless client facing interactions to effectively represent Syngene
- Ability to adapt to the dynamic team environment.
- Possess the knowledge and exposure to environment, health, and safety (EHS) practices
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team
Technical/functional Skills:
- Lead and oversee routine and customized in vitro ADME assays, including but not limited to metabolic stability, (microsomes, hepatocytes, S9 fractions), CYP inhibition and induction studies including time-dependent inhibition (TDI), reaction phenotyping, transporter assays, plasma protein binding, blood-to-plasma partitioning, solubility and permeability assays, metabolite identification support, Drug-drug interaction (DDI) risk assessments
- Manage, mentor, and develop a team of scientists and research associates.
- Seamless coordination with BA-DMPK group to design in-vitro ADME studies.
- Drive implementation of novel ADME technologies, methodologies, and automation platforms.
- Reporting of execution of the studies without any noncompliance.
- Preparation of study protocols, reports for IND/ NDA submissions.
- Well versed in report preparation for IND submissions.
- Understanding and knowledge about regulatory guidelines is desirable.
Educational Qualification: Ph. D with 10 years of experience or M. Pharm with 17+ years of experience.
Behavioral Skills:
Candidates need to be team players.
Ready to take on new challenges, committed to work and timelines
Should have learning attitude, enthusiastic and hard worker.
Good communication skills
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 accommodation for qualified individuals with disabilities.