Asst. Manager/ Manager - ADL

Job Description:

Position:         Asst. Manager/ Manager - ADL

Location:         Vapi

Experience:      8 - 10 Years

Industries:       Pharma - API

 Responsibilities:

• Analytical Development & Validation

•  

  Lead development, optimization, and validation of analytical methods for APIs, intermediates, and finished dosage forms.
• Perform method validation as per ICH, USP, EP, and IP guidelines.
• Support method transfer to QC and manufacturing sites.
• Handle analytical troubleshooting during development, scale-up, and commercial production.
• Regulatory & Compliance
• Prepare and review analytical documents for regulatory submissions (CTD, DMF, ANDA, NDA).
• Ensure compliance with cGMP, GLP, and data integrity requirements.
• Support regulatory inspections, audits, and responses to queries.
• Stability & Impurity Studies
• Oversee stability studies and data evaluation.
• Conduct impurity profiling, forced degradation, and degradation pathway studies.
• Ensure accurate interpretation and reporting of analytical data.
• Team Leadership & Management
• Lead, mentor, and develop ADL team members.
• Plan workload allocation, timelines, and resource optimization.
• Conduct training on analytical techniques and compliance requirements.
• Instrumentation & Documentation
• Ensure proper usage, calibration, and qualification of analytical instruments (HPLC, GC, LC-MS, UV, FTIR, etc.).
• Review SOPs, protocols, reports, and laboratory investigations (OOS, OOT, deviations, CAPA).
• Cross-Functional Collaboration
• Collaborate with Formulation Development, QA, QC, Regulatory Affairs, and Manufacturing teams.
• Support technology transfer and product lifecycle management activities.

Required Skill

• Strong expertise in analytical method development and validation.
• In-depth knowledge of ICH guidelines and pharmacopeial standards.
• Hands-on experience with advanced analytical instruments.
• Leadership, problem-solving, and decision-making skills.
• Excellent documentation, communication, and cross-functional coordination abilities.

Required Qualification: - M.Sc - Chemistry

Salary :- Upto 13.00 LPA

If you are interested for this opening please send updated resume same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-