Job Description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients 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 like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Chemist II

Job Description

Business: Pharma Solutions

Department: Analytical Quality Control

Location: Lexington

Job Overview

Reporting to the AQC (Analytical Quality Control) Group Lead, the primary purpose of the role is to perform complex testing of raw materials, in-process and finished products, maintain and calibrate analytical instruments in compliance with cGMP standards.

Shift

Days

Reporting Structure

This position reports to the AQC Group Lead.

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.
• Proficient at HPLC/GC analysis
• 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
• Initiate and resolve laboratory investigations.
• Train and provide guidance to entry level QC personnel and be a subject matter expert in laboratory practices.
• 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.
• Purchasing of laboratory reagents and consumables.

Qualifications:

• Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
• Minimum 5+ year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis
• Function as the team SME with regard to chemist duties and overall testing knowledge; provide team support as needed.
• Previous experience working within cGMP guidelines
• Experience working with potent, cytotoxic materials and parenteral drug products preferred
• High level of proficiency operating all Microsoft Office applications
• Excellent communication skills, both verbally and in writing
• Detail oriented and organized; able to manage conflicting priorities
• Demonstrated ability to work within a team environment, supporting a continuous operation manufacturing facility
• Excellent problem solving, communication, and interpersonal skills
• Ability to follow and can also explain to others written instructions and procedures.