We are currently looking for a Lead Chemist to oversee the Analytical Testing Services (ATS) laboratory function for a well-established pharmaceutical manufacturer with a strong commitment to product quality, regulatory compliance, and operational excellence. The company supplies high-quality generics and specialty pharmaceuticals across Southeast Asia and international markets. As the Lead Chemist, you will be responsible for helping the manager in managing the analytical testing activities and ensuring compliance with cGMP, NPRA, WHO, and international standards. You will also lead method development and validation efforts while guiding a team of skilled analysts in delivering reliable and timely data to support product release and regulatory submissions.
Reporting to: General Manager
Team Size: 20 - 30 people
Work Mode: Office-based
Culture: Seeking a detail-oriented, collaborative leader with a passion for continuous improvement and team development.
The Role:
Lead the day-to-day operations of the QC/ATS lab, including chemical and physical testing of raw materials, in-process samples, and finished products.
Oversee method development, validation, and transfer activities in line with ICH and pharmacopeial standards.
Ensure full compliance with cGMP, NPRA, WHO, PIC/S, and international regulatory guidelines.
Prepare and review analytical documentation such as SOPs, validation protocols, and test methods.
Manage laboratory investigations, including OOS/OOT results, deviations, and CAPAs.
Provide mentorship and technical training to junior chemists and lab analysts.
Collaborate with QA, Manufacturing, and R&D to support batch release, stability studies, and product launches.
Maintain and calibrate analytical instruments (HPLC, UV, GC, FTIR, dissolution testers, etc.) to ensure data integrity and operational readiness.
The Experience:
Master's Degree or PhD in Chemistry, Pharmaceutical Sciences, or related discipline.
Ideally with 8-10 years of QC lab experience, with at least 3-5 years in a supervisory or lead chemist role in a GMP-compliant pharmaceutical environment.
Strong hands-on experience with analytical instrumentation and troubleshooting, particularly HPLC, GC, UV, FTIR, and dissolution testing.
In-depth knowledge of ICH guidelines, Pharmacopoeial standards (USP, BP, EP), and method validation practices.
Demonstrated ability to manage regulatory inspections and third-party audits.
Strong leadership, organizational, and communication skills, with a commitment to continuous improvement and team development.
How to Apply:
Please provide your CV to Shash Prasanan at shashtidaran.prasanan@atomicgroup.sg, in either Microsoft Word document or PDF format.
