Assistant Manager -Analytical Development

To provide analytical support for the ongoing / new projects with respect to method development, method validation, method transfer, testing and troubleshooting, aligned and supporting to the organization objective by practicing the values and Play to Win behaviors.

Responsible for preventing accidents, avoiding risks to health and prohibiting environmental damage.

Responsible for respecting all the applicable laws and regulations and implement professional guidelines and use the best industrial practices

This role at MSAT Global Development Center, Goa requires focus and commitment associated with the deliverables and add value for the internal customers.

Essential job duties and responsibilities

Qualify, operate, calibrate, and maintain analytical instruments like HPLC, FTIR, GC, UV Spectrophotometer, LC-MS, GC-MS, Dissolution test apparatus & other analytical equipments.

Method Development for Small Molecules and Solid Oral Dosage Forms including other novel drug delivery systems and advanced dosage forms.

Develop Chromatographic method development which can extended to LC -MS , GC-MS or on other high end techniques for Genotoxic Impurities.

Develop stability indicating methods for estimation of actives from DS & DPs. Dissolution method development and correlation to in vivo studies.

Validation of analytical procedures in line with global guidelines.

Impurity profiling & Characterization for Unknown Impurities. Analyze development samples and stability samples of the drug product. Perform stability studies as per EU/ICH guidelines.

Perform analytical method transfer from development lab to QC lab in Manufacturing premises.

Author complex documentation, including SOPs, Specification, STPs, Protocols, and technical reports incorporating appropriate use of statistics.

Evaluate data for compliance to procedures and specifications.

Identify potential problems and proactively suggest solutions based upon analytical expertise and knowledge of product/process.

Provide program compliance and audit support

Knowledge, Skills & Competencies / Language

Knowledge of Good Laboratory Practices, Good Documentation Practices and Health, Safety & Environment (HSE) requirements pertaining to GMP environment

Key experience in method development and impurity profiling of Small Molecules and Solid Oral Dosage Forms.

Knowledge on Analytical aspects of Nitrosamine, NDSRIs & other genotoxic Impurities development.

Knowledge on transfer of analytical methods of assay, dissolution, estimation of impurities, etc. to Quality Control lab in manufacturing premises

Designing and execution of protocols and reports for analytical method, stability and validation, master documents – standard testing procedures, calibration / Qualification protocols, etc.

Must have experience with reference standard programs and critical reagents.

Knowledge of USP, EP, IP and global compendial regulations & requirements for method life cycle approaches & management.

Experience in qualifying (or managing qualification of) critical reagents, qualified materials (such as assay controls), and analytical reference standards.

Scientific technical writing ability including authoring and revising SOPs, qualification Protocols, and technical reports

Proficient in MS Outlook, Word, and Excel

Effective oral and written communication skills (English Language)

Qualifications

M.Sc. / M. Pharm / Ph. D with specialization in Pharmaceutical Analysis / Pharmaceutical Chemistry / Analytical Chemistry from a reputed university.

4 to 10 years’ experience with technical knowledge & Hands on experience of Sophisticated Analytical instruments like HPLC, GC, IR, UV Spectrophotometer, Mass Spectrometer, Dissolution Tester etc.

Excellent knowledge of English language (verbal and written).

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