Specialist - Analytical R & D (API)

Analytical Specialist to support analytical development and testing activities within a Contract Development and Manufacturing Organization (CDMO) environment. The role requires expertise in analytical method development, validation, structural characterization, elucidation, impurity profiling, impurity identification and troubleshooting for drug substances (APIs) and its intermediates, while effectively managing multiple client projects, timelines, and regulatory expectations. Serving as a mentor to junior team members. Proficient in interpreting analytical data and making informed decisions for the project.

Key Responsibilities:

Analytical Development & Validation

• Develop, optimize, validate, and transfer analytical methods in line with ICH and client-specific requirements.
• Support characterization of raw materials, intermediates, and APIs.
• Establish impurity profiles, assay methods, and residual solvent analyses.
• Review and closure of ELN experiment in time, timely release of analytical reports to R&D.
• Preparation of technical reports, quality reports, documentation and handling the audits.
• Calibration of instruments as per schedules, qualification of standards and its maintenance.
• Creation and review the analytical documents and calibrations of equipment’s and STP’s.
• Experience in structural elucidation, impurity identification, structural assignment and impurity profiling is necessary.
• Should be able to handle the incidents and investigations independently

Client Project Support

• Act as the technical point of contact for client analytical needs in development, scale-up, and commercial manufacturing stages.
• Prepare and present technical data, development reports, and analytical strategies to clients.
• Coordinate analytical activities to meet project timelines and contractual deliverables.

Instrumentation & Troubleshooting

• Operate and maintain HPLC, GC, LC-MS, GC-HS, FTIR, UV, KF, DSC, and other relevant equipment.
• Resolve technical and analytical challenges promptly to ensure project continuity.

Regulatory Compliance & Documentation

• Prepare method validation protocols & reports, method development reports, cut-off studies report, incident investigation reports and Standard Operating Procedures.
• Ensure adherence to internal procedures, and data integrity principles during all testing activities.
• Support client and regulatory audits (USFDA, EMA, MHRA, WHO).
• Prepare structural characterization and elucidation reports using 1H NMR, 13C NMR, COSY, NOESY, HSQC, HMBC, IR, UV, SOR so on.
• Should be able to interpret and prepare thermal characterization and powder property characterization reports as per project requirements

Cross-functional Collaboration

• Work closely with process chemistry, formulation development, quality assurance, and manufacturing teams.
• Support technology transfer between development and commercial sites.

Education & Experience:-

• M.Sc, or M.Pharm with 10+ years’ experience in the Analytical R&D; 4-5 years’ experience with PhD. Candidates should be flexible to travel to other cities such as Vizag, Miryalaguda, and CTO locations as required for project execution.

Technical Skills:

• Strong command of chromatographic, spectroscopic, and other analytical techniques.
• Experience with method development for complex products and diverse client needs.
• Proficiency in chromatography data systems (Empower, Chromeleon).
• Regulatory Knowledge: ICH Q2, Q3, GMP, GLP, USP, EP, JP guidelines.

Preferred Qualifications

• Direct experience working in a CDMO.
• Knowledge of early and late phase molecules.
• Experience in managing analytical work across multiple projects simultaneously.

Key Attributes

• Strong client-facing communication skills.
• Ability to work in a fast-paced, deadline-driven environment.
• High attention to detail and scientific rigor.
• Effective multi-tasking and prioritization skills.