The U.S. Pharmacopeial Convention (USP) Senior Scientist II, Reference Standards Laboratory in Hyderabad, India
Senior Scientist II, Reference Standards Laboratory
This is a supervisory position in RSL department under stability section, guiding a team of scientists and performing the required analytical testing as part of projects and maintaining the GLP environment in the Laboratory. The person will contribute to the scientific expertise and work ethic of the laboratory through a broad range of technical support and knowledge. The person has mastered many common techniques in the laboratory and is able to contribute their own observations and input to difficult projects. The incumbent will provide technical assistance to the Stability Program by allotting analytical tests, reviewing analytical data, and preparing summary reports.
Roles and Responsibilities:
Coordination with Lab staff and senior Manager to maintain the Lab as per GLP and safety practices.
Overall responsible for drafting the test protocols, executing the projects, compiling the project reports and response to QA observations.
Allotment of tests to the individual scientists based on the priority of the projects.
Monitoring the projects like to receive, under Process, Archival, Disposal etc.
Responsible for review of the projects and preparing the summary report.
Demonstrates solid scientific approach to analysis in the laboratory;
Routinely applies personal experience, academic training, and technical insights – including emerging sciences – to solve complex technical problems within the laboratory;
Conducts stability testing for reference standard candidates using appropriate methods;
Performs peer review of analytical data and results;
Prepares stability reports, evaluates chemical stability trends, develops predictive stability models based on stability data.
Reviews literature to better understand chemical stability of the materials;
Completes the projects as per the project timelines and priorities.
Compiles project reports and responds QA observations.
Demonstrates a strong desire to continue learning and grow personal capability;
Pursues, recommends, and implements new approaches or processes to improve laboratory operations;
Positively influences project direction by ensuring own work is congruent with overall direction of laboratory projects;
Assists with other testing programs and housekeeping duties in the laboratory as needed.
Prepares and reviews SOPs.
Providing hands on training to the new joiners and existing reporting staff whenever required.
Participate in target setting process and coordinate with supervisor.
Ensuring the implementation of GLP, safety systems in the labs.
Identification of training needs of the team and taking training classes.
Ensures the implementation of GLP, safety systems in labs.
Ensures the calibration of the equipment as per the schedule.
Communicates with RSE HQ regarding the project issues and maintaining good relationships.
Indents chemicals, columns, Glassware, etc. and procures them by coordinating with lab operations and purchase department in advance keeping in mind the project deadlines.
Ensures and follows USP mission, policies and procedures.
Maintains good relationship with HR, Purchase, accounting, IT and other dept.
Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.
Supporting Collaborative testing, Verification and other departmental teams in terms of project review, execution and approval whenever needed.
- M.Sc. in Analytical / Organic Chemistry.
Minimum 10 to 12 years of relevant laboratory experience.
Prior experience in a high volume pharmaceutical manufacturing QC laboratory or contract pharmaceutical analytical testing laboratory.
Ability to lead projects to completion with a high degree of scientific expertise.
Expertise in wet analytical techniques & spectroscopic analysis along with HPLC & GC, operation and troubleshooting, strong communication and presentation skills, both verbal and written, experience working in the pharmaceutical industry strongly preferred.
Knowledge of DEA, ICH guidelines and FDA regulations, and experience with compendial procedures and compliance strongly preferred.
Proficiency with electronic documentation systems strongly preferred.
Takes personal responsibility to ensure work is delivered on time and is the highest possible quality.
Skills to anticipate, troubleshoot, and solve technical problems.
Hyderabad, Andhra Pradesh, India
Job Category Scientific