Executive / Sr. Executive - ADL (Analytical Development Laboratory)

Why This Role Matters

Analytical Development plays a vital role in ensuring the quality, safety, and regulatory compliance of pharmaceutical products. Accurate method development, validation, and stability testing are essential for successful product approvals and lifecycle management.
At APDM Pharmaceuticals, this role supports formulation development, technology transfer, and regulatory submissions by establishing robust analytical methods. The Sr. Officer / Executive / Sr. Executive in Analytical Development directly contributes to maintaining product integrity and compliance at the Sakodara, Gujarat manufacturing facility.

Job Description

APDM Pharmaceuticals is seeking experienced professionals for the Analytical Development department with 3 to 5 years of experience in pharmaceutical analytical laboratories. The selected candidate will be responsible for method development, method validation, stability analysis, and documentation as per regulatory guidelines.
This role requires strong technical expertise in analytical instruments and a thorough understanding of GMP and regulatory requirements.

Key Features of the Role

• Hands-on experience in Analytical Development Laboratory (ADL)
• Exposure to method development and validation activities
• Involvement in regulatory documentation and dossier support
• Opportunity to work with advanced analytical instruments
• Cross-functional collaboration with R&D, QA, and Production teams
• Growth opportunities within pharmaceutical R&D operations

Responsibilities

• Perform analytical method development and validation
• Conduct routine and non-routine analysis of APIs and finished products
• Execute stability studies and prepare stability reports
• Handle analytical instruments such as HPLC, GC, UV, and Dissolution apparatus
• Prepare and review analytical documentation as per GMP guidelines
• Support technology transfer and scale-up activities
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results
• Maintain laboratory records and ensure data integrity compliance
• Assist in preparation of regulatory submission documents
• Ensure calibration and maintenance of laboratory instruments

Required Qualifications

• 3 to 5 years of experience in Analytical Development within pharmaceutical industry
• Strong knowledge of method validation and analytical techniques
• Experience in handling HPLC, GC, UV, Dissolution, and related instruments
• Understanding of ICH guidelines and GMP requirements
• Experience in stability study management

Educational Requirements

• M.Sc in Chemistry / Analytical Chemistry – Preferred
• M.Pharm (Pharmaceutical Analysis or related specialization) – Preferred
• Strong academic background in analytical sciences

Experience and Skills

• Expertise in analytical method development and troubleshooting
• Strong understanding of regulatory documentation requirements
• Knowledge of data integrity principles
• Analytical thinking and problem-solving skills
• Good documentation and reporting ability
• Ability to work independently and within cross-functional teams
• Familiarity with GLP and laboratory compliance standards

Salary Insights

• Performance-based increments
• Standard pharmaceutical industry benefits
• Learning and development opportunities within R&D
Compensation will be aligned with experience and technical proficiency.

Company Overview

APDM Pharmaceuticals is a growing pharmaceutical company committed to creating a healthier future through quality-driven manufacturing and innovation. Operating from its plant in Sakodara, Gujarat, the company focuses on regulatory compliance, research excellence, and sustainable growth in the Indian pharmaceutical sector.
The organization provides a structured environment for analytical and research professionals to build long-term careers in pharmaceutical development.

FAQs

Q: Is method validation experience mandatory?
A: Yes, practical experience in method development and validation is preferred.

Q: Will the role involve regulatory audit exposure?
A: Yes, candidates may support documentation during audits and inspections.

Q: Is hands-on HPLC experience required?
A: Yes, strong experience with HPLC and related analytical instruments is essential.

Q: What determines Officer vs. Executive vs. Sr. Executive level?
A: Experience depth, technical expertise, and independent project handling capability.

Application Tips

• Clearly mention instruments handled and years of experience
• Highlight specific methods developed or validated
• Include experience in OOS investigations and stability studies
• Mention regulatory exposure (ICH, GMP, data integrity)
• Quantify achievements such as number of validations completed
• Keep technical skills section clearly structured in your resume