ADL executive

This role is for one of the Weekday's clients

Salary range: Rs 400000 - Rs 500000 (ie INR 4-5 LPA)

Min Experience: 1 years

Location: Tarapur , Mumbai

JobType: full-time

We are seeking a detail-oriented and motivated ADL Executive to join our Analytical Development Laboratory (ADL) team. The role will focus on analytical method development, validation, and routine analytical support for active pharmaceutical ingredients (API). The ideal candidate will have hands-on experience in analytical techniques, strong documentation practices, and a solid understanding of regulatory expectations. This position offers exposure to end-to-end analytical development activities in a quality-driven environment.

Key Responsibilities

• Perform analytical method development for APIs in accordance with project requirements, pharmacopeial standards, and regulatory guidelines.
• Execute analytical method validation including accuracy, precision, linearity, specificity, robustness, LOD/LOQ, and system suitability studies.
• Conduct routine and non-routine analysis of APIs using validated and non-validated methods.
• Support analytical method transfer activities from development to quality control or manufacturing sites.
• Operate and maintain analytical instruments such as HPLC, UPLC, GC, UV-Vis, IR, and related laboratory equipment.
• Prepare, review, and maintain analytical documentation, including protocols, validation reports, test methods, raw data, and summary reports.
• Ensure compliance with cGMP, GLP, and data integrity requirements during all laboratory activities.
• Participate in investigations related to out-of-specification (OOS), out-of-trend (OOT), and deviation events, providing analytical support and root cause analysis.
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Regulatory Affairs to support product development and submissions.
• Maintain laboratory safety standards, calibration schedules, and good housekeeping practices.

Required Skills & Competencies

• Strong hands-on experience in API analysis is mandatory.
• Proven expertise in analytical method development and validation.
• Sound knowledge of ICH guidelines (Q2, Q6), pharmacopeial standards (USP, EP, IP), and regulatory expectations.
• Proficiency in interpreting analytical data and troubleshooting method-related issues.
• Good understanding of cGMP, data integrity principles, and laboratory compliance.
• Ability to work independently as well as in a collaborative team environment.
• Strong documentation, communication, and problem-solving skills.

Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Analytical Chemistry, or a related discipline.
• 1–6 years of relevant experience in an Analytical Development Laboratory within the pharmaceutical or API industry.
• Prior experience working in a regulated environment is preferred.