Director / Senior Director - Analytical R&D

Job Description

To lead and manage analytical development activities for complex injectable and solid oral dosage forms, ensuring robust method development, validation, transfer, and regulatory compliance across the product lifecycle—from early development to commercialization.

Key Job Responsibilities

1. Analytical Strategy & Leadership

• Define and implement analytical strategies for complex injectables microspheres, suspensions, emulsions, liposomal systems, depot injections, sterile products) and solid oral products (IR, MR, modified release).
• Lead, mentor, and develop analytical teams across formulation support, method development, and stability.
• Act as a technical expert and decision-maker for complex analytical challenges.

2. Method Development & Validation

• Oversee development, optimization, and validation of analytical methods for:
• Provide inputs I method transfers activities to QC, CMOs, and CROs.

3. Regulatory Support & Submissions

• Provide analytical inputs for ANDA / NDA / MAA / DMF submissions.
• Review and approve analytical sections during Submissions

4. Product Lifecycle & Technical Support

• Support formulation development with analytical insights during:
• Lead investigations for OOS, OOT, deviations, and root cause analysis.

5. Cross-Functional Coordination

• Coordinate with external labs (CROs, CMOs) for specialized testing.
• Work closely with Formulation R&D, Regulatory Affairs, QA, QC, and Manufacturing teams.

Qualifications & Experience

Education

• M.Sc. / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field.

Experience

• 20+ years of experience in pharmaceutical analytical development.
• Strong hands-on and leadership experience in:
  • Complex injectables
  • Solid oral dosage forms
• Proven exposure to regulated market submissions (US/EU).

Key Skills & Competencies

• Strong expertise in chromatographic techniques (HPLC, UPLC, GC).
• Knowledge of advanced characterization techniques (PSD, SEM, FTIR, DSC, XRD).
• Deep understanding of guidelines .
• Excellent problem-solving, communication, and leadership skills.