Perform analytical method development, verification/validation using a wide variety of analytical techniques, such as HPLC. GC, FTIR, UV, LC/MS, GC/MS, etc. for container closure materials, drug substance, and drug product pharmaceutical formulation.

Conduct Extractables studies for container closure/packaging materials such as resin, plastic film, stoppers, label inks, adhesives, etc. and leachables studies for drug product pharmaceutical formulation.

Conduct impurities identification in related to drug substance, drug products, extractables/leachables.

Plans, organizes, and conducts analytical experiments and research activities to support drug product development and commercialization.

Review data, notebooks, and reports to ensure compliance with specifications, standard operating procedure, and regulatory requirements

Author pertinent protocols, reports, and relevant CMC sections for regulatory filings.

Collaborates with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques/products.

Requires working knowledge of professional field and pharmaceutical industry in cGMP and/or R&D environment.

Working knowledge of chemical theories, concepts, test methods and instrumental methods,analytical and research skills.

Experience in chemical impurity identification and characterization with LC/MS, GC/MS in related to extractables/leachable's preferred.

Knowledge of USP, EP, FDA CFR & ICH, ISO regulations and guidelines in regarding extractables/leachables and impurities.

Experience in analytical method development/ optimization, validation, troubleshooting, etc.

Proficiency with Microsoft Office Applications (e.g. Word, Excel, Power Point).

Strong communication (written and verbal), attention to detail and organizational skills as demonstrated in writing project proposals, protocols and reports.

Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.

Judgement is required in resolving complex problems based on experience.

Ph.D. or M.S. degree in analytical chemistry, organic chemistry, pharmaceutical chemistry or a related science discipline.

4-6 years related experiences in pharmaceutical industry preferred.