Business: Pharma Solutions
Department: Analytical Quality Control (AQC)
Location: Lexington
REPORTING STRUCTURE:Â
This position reports to the AQC Group Lead.Â
JOB OVERVIEW:Â
Reporting to the AQC Group Lead, the Chemist I performs testing of raw materials, in-process and finished products, and maintains and calibrates analytical instruments in compliance with cGMP standards.
KEY RESPONSIBILITIES:
•    Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc. with minimum supervision
•    Testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
•    Document laboratory work according to, GDP, cGMPs, and SOPs
•    Troubleshoot, calibrate and maintain instruments as required
•    Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
•    Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
•    Participate in laboratory investigations
•    Perform peer review of analytical documentation
•    Follow safety procedures when working in laboratory.
•    Understand and comply with cGMPs and other regulations
•    Maintain the laboratory in an organized and neat manner
•    Act as backup for Material sampling activities.
•    Purchasing of laboratory reagents and consumables
QUALIFICATIONS:
•    Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
•    Minimum 1-year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis strongly preferredÂ
•    Experience working with potent, cytotoxic materials and parenteral drug products preferred
•    High level of proficiency operating all Microsoft Office applicationsÂ
•    Excellent communication skills, both verbally and in writing
•    Detail oriented and organized
•    Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility
•    Excellent problem solving, communication, and interpersonal skills
•    Ability to follow written instructions
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Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
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