Chemist II

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 55,000 - 85,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Chemist II in Lexington to perform complex testing of raw materials, in-process and finished products. The role requires maintaining analytical instruments, adhering to cGMP standards, and guiding entry-level QC staff.

You will work with HPLC/GC analysis, document findings, and support investigations while ensuring accuracy and compliance in a fast-paced manufacturing environment.

Qualifications

• 5+ years hands-on quality control experience in a laboratory.
• Proficiency with HPLC/GC analysis.
• Experience working under cGMP guidelines.
• Experience with potent, cytotoxic materials and parenteral drug products preferred.
• Excellent communication skills, both verbal and written.

Responsibilities

• Perform routine/non-routine testing of raw materials, in-process and finished products.
• Maintain and calibrate analytical instruments in compliance with cGMP standards.
• Document laboratory work according to GDP, cGMPs, and SOPs.
• Troubleshoot, calibrate and maintain instruments as required.
• Write SOPs, laboratory protocols and reports; train entry level personnel.

Skills

HPLC/GC analysis

Communication

Team SME

Microsoft Office

Education

Bachelor of Science in Chemistry

Tools

Microsoft Office

Job description

Be the First to Apply 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.