Conducts basic laboratory activities with limited supervision following Standard Operating Procedures. Assures that quality standards are met. Documents activities following cGMP rules.
Conduct laboratory activities with limited supervision including for example: analyzing raw materials, in-process materials and finished pharmaceutical products for quality, safety, purity, strength and identity using applicable methods or manufacturing drug product, following the cGMP, EH&S and other relevant guidelines of Lupin, FDA and other governing bodies.
Independently set up and operate basic/routine lab equipment with limited supervision, prepare reagents, solvents and solutions for analytical and formulation activities. Prepare and maintain accurate records in lab notebooks of all testing performed. Process analytical data on lab equipment such as HPLC/UPLC, enter data in spreadsheets and conduct routine calculations. Support the manufacture of Dry Powder Inhaler and Metered Dose Inhaler drug products.
Perform equipment qualification and calibrations as directed
Execute approved method transfer protocols
Assist in the training of other chemists
Perform other tasks as assigned
Participate in project activities and support project timelines and proactively contribute to meeting the team objectives. Communicates effectively with team members.
Establish and maintain effective relationships with team members
Conduct lab work in accordance with SOPs; follow corporate safety rules and procedures.
Comply with all Corporate guidelines and policies
This job requires a BA/BS degree or above in Chemistry or Science related field.
Minimum 2 years’ experience in Pharmaceutical R&D. Proven ability and/or experience with compendial test methods or manufacturing equipment.
Understanding of pharmaceutical equipment and computerized systems for operation and troubleshooting. Specific experience with analytical and/or process equipment used in laboratories such as HPLC, IR/FTIR, UV-Vis AA, powder blender etc.
Knowledge and understanding of the FDA cGMP requirements as it applies to the Pharmaceutical industry.
Effective English written and oral communication skills. Ability to write short technical documents such as memos, laboratory investigations, protocols and reports with supervisions as needed.