What are the responsibilities and job description for the Chemist II position at Piramal Enterprises?
Business: Pharma Solution
Department: Quality Control
Location: Lexington
Job Overview
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. This is a night shift role.
Reporting Structure
Directly reports to 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.
Education
- Bachelor of Science in Chemistry, Pharmaceutical Science, or other closely related scientific field
Experience
- Minimum 3 year hands-on experience performing quality control work within a laboratory, proficiency with HPLC/GC analysis
- Previous experience working within cGMP guidelines
- Experience working with potent, cytotoxic materials and parenteral drug products preferred
Competencies
- High level of proficiency operating all Microsoft Office applications
- 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
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
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.
