General Manager/Assistant Vice President - Analytical Research & Development - Pharmaceutical

GM / SVP - Analytical Research & Development (Pharmaceuticals)

API & Formulation experience is a requirement

Location - Mumbai

Position Summary

This position has the overall responsibility for managing the analytical laboratory and systems in line with the regulatory guidelines. Incumbent must have multidisciplinary experience in the field of Analytical Research & Development for API and Formulations.

Job Requirements

- Strong background in reviewing investigation reports, calibration reports, Method development protocols, stability and development reports, analytical method development and technology transfer protocols. Core competencies in validation of test methods

- Strong exposure in Solid State characterizations of API and formulations (XRD, DSC, TGA, Particle Size)

- To facilitates & ensure development of commercially viable process that is scalable for commercial production.

- Proven expertise in setting up an analytical laboratory and systems in the laboratory.

- Aptitude to manage analytical processes from Pre-formulation to the tech transfer to manufacturing site. Proficiency in development of stable and bio-equivalent drug product.

- Providing support to all activities related to formulation development and routine analytical development

- Taking care of the Technical investigations of OOS, OOT, Justification reports, deviations and its assessment by identifying root cause investigation and appropriate CAPA

- Responsible for life cycle management; API source changes; efficiently handling analytical method development & validation

- Ensure quality by design stability indicating analytical method development, Reverse Engineering of Reference Listed Drug Sample, analytical method validation and dissolution studies including Multi-media and Dose- dumping studies

- Network with vendors of Contract Research Organization for projects in functional areas with their costing, timelines and to resolve any outstanding issues

- Accomplished instrumental troubleshooting, calibration and handling of sophisticated instruments like - HPLC, UPLC, HPTLC, GC, UV-Vis. Spectrophotometer, FTIR, Dissolution tester, Particle size analyzer, Polarimeter, Auto Titrator, DSC, AAS, Next Generation Impactor, Anderson Cascade Impactor, Twin Stage Liquid Impinger and related instruments in analytical department

- Expertise in documentation and subsequent action required for current Good Laboratory Practice, Out of Trend and Out of Specification Situations, New Product Review Procedurals and Failure Investigations

- Active knowledge of managing departmental budget, Annual Maintenance Contracts, for the instruments in the lab & stability chambers

- Ability to identifying areas of bottlenecks & breakdown and non-conforming products; taking steps to achieve zero accident & customer complaints, through the application of troubleshooting tools

- Implement techniques for run time reduction & executing cost saving techniques to achieve substantial reduction in quality expenditure

- Effective in communicating status, progress and challenges internally and externally

- Human capital management responsibility (including hiring right skills, training, engagement, skills development etc.).

Additional - 

Provides work direction, additionally has the responsibility for performance management, promotions, transfers, discipline and termination within the business.

Lead an experienced team of professionals and provides training on current practices & guidelines.

Required Knowledge and Skills:

- Experience in Creating, developing and implementing strategies for efficient and cost-effective management of allocated resources.

- Experience in formulating policy and developing new strategies and procedures.

- Ability to analyse and interpret large volume of data

- Knowledge of Current Good Manufacturing & Laboratory Practices as per regulatory guidelines of USFDA, MHRA and other agencies.

- Preparing clear and concise correspondence.

- Analyzing problems, identifying solutions and implementing recommendation for problem resolution.

- Establishing and maintaining cooperative working relationships with others.

- Managing multiple projects, duties and assignments.

- Strong analytical and reasoning abilities.

- Ability to be persuasive and give leadership to subordinates.