Position at Dr. Reddy's Laboratories, Inc.
At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Associate QC/Sr. Scientist- Methods Validation Chemist (New Product)
This position will be based in Shreveport, LA.
The position will be part of a team of Chemists in the Quality Control laboratory that supports the analytical testing of pharmaceutical raw materials, finished products, in-process materials, and cleaning validation activities. Special emphasis will be placed on the development and validation of analytical test methods.
Bachelor Degree in Chemistry/Biochemistry is required.
Minimum 5 years+ experience working in a quality control laboratory of the pharmaceutical industry with adherence to Good Manufacturing Practice Regulations of FDA.
Working knowledge of compendia guidance and ICH guidelines with successful application through actual project work.
Work requires thorough understanding and proficiency in the use of HPLC, GC, IR, TOC, KF, UV/VIS Spectroscopy, Dissolution and wet chemistry and other analytical techniques.
Knowledge of the following: Laboratory safety and hazardous waste requirements, Data acquisition applications and databases, USP Pharmacopeia.
Work requires the ability, initiative, and judgment to perform detailed technical work outlined in procedures with minimum supervision along side with experienced chemists in the laboratory.
Analytical methods development/validation/qualification experience is highly desirable.
Knowledge and on the job experience with (1) raw materials and drug product testing, (2) SAP, and (3) Empower Data system is highly desirable.
Analysis of raw materials, drug products, in-process materials, stability samples, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
Preparation of reagents/standards/medias needed for analysis according to established methods.
Disposal of hazardous waste according to environmental regulations and company/departmental procedures.
Tabulation and interpretation of results of analysis as recorded in notebooks, test reports and logbooks.
Capable of self-scheduling of work assignments
Assures right-first-time execution of departmental methods and SOPs.
Ability to develop and validate instrumental methods in support of Drug Substances and Drug products
Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document.
Lead all analytical method validation, verification, and transfer activities as required by their area.
Supports Material Evaluation Process for new materials
Participates in inter-departmental task teams.
Provides training for new or existing personnel.
Performs other miscellaneous duties as required.
Works flexible hours including weekends and evenings to accommodate the production / validation schedule.
Equal Opportunity Employer: Minorities/Women/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Dr. Reddy's Laboratories