Extractables & Leachables (E&L) Analyst

Sipra Labs Ltd; Hyderabad; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Sipra Labs Ltd in Hyderabad invites an experienced Analytical Chemist specializing in Extractables & Leachables (E&L) to design and execute comprehensive E&L studies for container-closure systems, packaging and devices.

Responsibilities include designing study protocols, performing GC-MS, LC-MS/MS and ICP-MS analyses, applying ALCOA++, and compiling reports for regulatory submissions (USP <1663>/<1664>, ISO 10993).

Qualifications

• Professional experience in extractables & leachables (E&L) studies.
• Hands-on experience with glass/ polymer matrix leachables.
• Knowledge of regulatory expectations (USP <1663>/<1664>, ISO 10993).

Responsibilities

• Design and execute E&L study protocols for container-closure systems, packaging, devices and process materials.
• Perform controlled extraction studies and leachables analysis on drug products/simulants.
• Analyse samples by GC-MS, LC-MS/MS, ICP-MS and headspace for organic, inorganic and volatile species.
• Identify and quantify extractables/leachables with structural elucidation and library matching.
• Apply the Analytical Evaluation Threshold (AET) and toxicological/safety-threshold concepts with QA/Tox.
• Develop and validate E&L methods and manage reference standards/surrogates.
• Compile E&L study reports for regulatory submissions (USP <1663>/<1664>, ISO 10993, PQRI).
• Record raw data, spectra and interpretations contemporaneously (ALCOA++) and support audits.

Skills

GC-MS

LC-MS/MS

ICP-MS

Headspace analysis

ALCOA++

Education

M.Sc (Chemistry/Analytical Chemistry)

M.Pharma

Job description

Design and execute extractables & leachables (E&L) studies for container-closure systems, packaging and medical devices using GC-MS, LC-MS/MS and ICP-MS, ensuring scientifically sound, data-integral E&L data aligned to USP <1663>/<1664>, ISO 10993, PQRI and regulatory expectations.

Key responsibilities

• design and execute E&L study protocols for container-closure systems, packaging, devices and process materials
• perform controlled extraction studies and leachables analysis on drug product/simulants
• analyse samples by GC-MS, LC-MS/MS, ICP-MS and headspace for organic, inorganic and volatile species
• identify and quantify extractables/leachables with structural elucidation and library matching
• apply the Analytical Evaluation Threshold (AET) and toxicological/safety-threshold concepts with QA/Tox
• develop and validate E&L methods and manage reference standards/surrogates
• compile E&L study reports for regulatory submissions (USP <1663>/<1664>, ISO 10993, PQRI)
• record raw data, spectra and interpretations contemporaneously (ALCOA++)
• and support internal, NABL, FDA and client audits.

Grade LM-4 | Individual Contributor / Specialist | Division: Analytical (Analytical Chemistry – Extractables & Leachables) | Education: M.Sc (Chemistry/Analytical Chemistry) or M.Pharma | Experience: 6–10 years in E&L / trace-organic analysis | Reports to: Group Leader – Analytical.