Job Description

Job DetailsJob Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Position Type: Full TimeJob Shift: DayJob 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.
QualificationsQualifications & 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.