Manager – Analytical Development

Location: Chennai, India

Employment Type: Full‑time, On‑site

Company Description

SanSphere Pharma Pvt. Ltd. is a growing pharmaceutical organization committed to developing high‑quality, safe, and effective medicines for global markets. We focus on innovation across research, development, and manufacturing, supported by strong scientific practices, regulatory compliance, and continuous improvement.

Our collaborative team environment encourages qualified growth, ethical conduct, and meaningful contributions to healthcare. Candidates joining SanSphere Pharma will work in a dynamic setting with opportunities to influence impactful pharmaceutical solutions.

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Role Description The Manager – Analytical Development will lead analytical method development, validation, and optimization activities to support product development, regulatory submissions, and commercial readiness. This role oversees laboratory operations, analytical strategy, data review, and compliance with global regulatory standards.

The manager will work closely with Formulation R&D;, Quality Control, Regulatory Affairs, and Manufacturing teams to troubleshoot technical challenges, support stability programs, and enhance testing methodologies.

Responsibilities also include preparing high‑quality technical documentation, training team members, and driving continuous improvement in analytical practices.

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Key Responsibilities

Lead development, optimization, and validation of analytical methods for multiple dosage forms (solid oral, liquid oral, topical, and injectable).

Oversee analytical development projects and ensure timely execution aligned with regulatory and quality expectations.

Review, interpret, and approve analytical data with strong attention to accuracy and compliance.





Support formulation development, stability studies, and troubleshooting of analytical or product‑related issues.

Prepare and review technical documents including method validation protocols/reports, stability summaries, and analytical development reports.

Contribute to ANDA submissions, including drafting and reviewing Module 3 (Quality) sections.

Support regulatory interactions by preparing deficiency responses, justifications, and analytical clarifications.

Ensure adherence to cGMP, ICH guidelines, and internal quality systems.

Mentor and guide analytical scientists; oversee laboratory operations and instrument readiness (HPLC, GC, UV, dissolution, etc.).

Drive continuous improvement initiatives in analytical workflows, documentation, and laboratory compliance.

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Qualifications

Master’s degree or higher in Pharmaceutical Sciences, Chemistry, or a related discipline.

10–12 years of progressive experience in analytical development within the pharmaceutical industry.

Strong background in analytical method development, method validation, and troubleshooting.

Hands‑on experience with analytical instrumentation (HPLC, GC, UV, dissolution, etc.).

Solid understanding of Quality Control, cGMP, ICH guidelines, and regulatory expectations.

Experience supporting R&D;, formulation development, and stability studies.

Demonstrated experience in ANDA submissions, Module 3 writing, and regulatory deficiency responses.

Exposure to analytical development for multiple dosage forms (solid, liquid, topical, injectable).

Strong documentation, data analysis, and reporting skills with high attention to detail.

Proven ability to lead teams, manage multiple projects, and collaborate effectively across functions.

Candidates with a blend of academic research and industrial experience are strongly preferred.

📌 Manager Analytical Development (Chennai)
🏢 Sansphere Pharma
📍 Chennai