Job Title:Junior/Senior Analytical Development Scientist - Injectables
Job Location:Bengaluru
Department:DPA FD
About Syngene :Syngene () 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 companys 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
Job Purpose:
Analytical development supporting Formulation development
Job Description:
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 Particulate matter Particle size distribution etc.
Knowledge of various regulatory guidelines w.r.t. method development product development and documentation
Knowledge of method development for injectable formulations w.r.t. tests like assay degradation products dissolutions content uniformity cleaning method degradation products of liposomes free and bound API assay 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 note book 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
Key Responsibilities:
Routine analysis of samples
Method development
Instrument calibrations
Documentation
Report preparation
Miscellaneous lab responsibilities
Educational Qualification:
/ .
Technical/functional Skills:
Candidate should have good proficiency for MS-office tools
Should be able to search scientific literature on-line
Experience:
3-8 Years
Behavioral Skills:
Strong commitment towards work and a high level of dedication enthusiasm motivation and persuasive ability in a team.
Good speaking-listening writing skills attention to details proactive self-starter.
Ability to work successfully in a dynamic ambiguous environment.
Ability to meet tight deadlines and prioritize workloads.
Ability to develop new ideas and creative solutions.
Should able to work in team and flexible for working in shifts.
Should be a focused employee.
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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Required Experience:
Senior IC
We are an innovation-led contract research, development and manufacturing organization offering end-to-end solutions to fulfil R&D and manufacturing requirements of our clients