JOB DESCRIPTION Job Title: Lead Scientist - Drug Product Analytical Development-Injectable Job Location: Bangalore Department: Drug Product Analytical – Formulation Development 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: • Analytical development supporting Formulation development • Routine analysis of samples • Method development • Instrument calibrations • Documentation • Report preparation • Miscellaneous lab responsibilities Role Accountabilities • Candidate should have very good educational and theoretical background. • Candidate should have knowledge of calibration, method development and troubleshooting using various instruments like KF auto titrator, dissolution (I, II & IV), spectroscopic instruments e.g. UV spectrometer, IR and Chromatographic instruments e.g. HPLC, GC • Knowledge of various regulatory guidelines w.r.t. method development, product development and documentation • Knowledge of method development for oral dosage forms w.r.t. tests like assay, degradation products, dissolutions, blend uniformity, content uniformity, cleaning method, etc. • Knowledge of specification setting for oral dosage forms, in-process specifications as well as product specifications • Knowledge and operating of instruments like LC-MS, GC-MS will be added advantage • Good understanding of Documentation as per GxP requirements • Online Lab notebook writing • Method development report preparation – Assay, Degradation products, Dissolution, cleaning method, etc. • Method of Analysis, Test report, SOP preparation • Calibration documentation • Review of documents generated by peers or juniors • Should be able to search scientific literature on-line • Should be a team player and able to coach juniors technically Syngene Values All employees will consistently demonstrate alignment with our core values • Excellence • Integrity • Professionalism Looking for an experienced Analytical Development Scientist with strong expertise in method development. Skills and Capabilities • Technical/functional Skills: • Candidate should have good proficiency for MS-office tools • Should be able to search scientific literature on-line Education: M. Pharm / M.Sc. Experience : 4+ Years 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.