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• Analytical R&D Project Leader with proven record of high accomplishments and successful filings of number of IND’s, ANDA’s and NDA’s. Possess in depth knowledge of pharmaceutical drug development process and ICH guidelines in a cGMP environment.

• Coordinated project activities between R&D analytical and drug product development, quality assurance, clinical manufacturing unit, technical operations, clinical development and Regulatory affairs.

• Managed early and late phase projects in-house and at the contract labs. Setting and implementation of specification for APIs and drug products. Oversee development of analytical methods using state of the art instruments and validation of analytical methods (using Qbd strategy) to support the drug synthesis and drug product development for solid dosages and liquid formulations.

• Held responsibilities for auditing with quality assurance for selection of contract labs, continued surveillance for cGMP compliance at the contract labs and review and approval of the contracts for the analytical development of API, intermediates and drug products at contract labs. Interfaced with contract lab staff on regular basis by holding weekly teleconferences to evaluate project progress and implementation of strategies to support API and drug product formulation development. Troubleshooting and monitoring of analytical activities by email, phone and site visits.

• Developed strategies for management of outsourcing testing needs, in consideration of timelines, risk management and business priorities. Coordinated with legal and quality assurance to establish confidentiality agreement, service terms and conditions.

• Set up stability studies in-house and at the contract labs, written stability protocols in LIMS. Reviewed analytical data package for clinical batch release for the drug substance and drug product. Written method transfer protocols for methods developed in-house and validated at the contract labs and reviewed method validation reports.

• Written SOP’s, analytical methods / method validation protocols, method validation reports, stability protocols using LIMS. Written development, clinical, intermediate and registration stability reports.

• Coordinated analytical data for the preparation of Reg. CMC documentation for filing IND and NDA and ANDA for Europe and US. Answered health authority questions to FDA and EMEA.

• Performed lab investigations, written lab investigation reports (LIR), FIR, RCA and CAPA.

• Responsible for analytical lab instruments purchase, calibration and maintenance. Provided input for budget.

• Performed GLP/cGMP Lab audits. Participated in global team audits and EU health authority’s audits and PAI. Written performance appraisals for the analysts, in-house and at the contract labs.

• Excellent project management and communication (oral and verbal) skills. Written internal procedures/publications. Made oral/poster presentations at national scientific conferences.