Career as pharmacist

Academic Path :

1) Physic, Chemistry and Biology is compulsory in 12th

2) B.Pharm.

2) M.Sc. (Pharmacology)

3) Ph.D. (Pharmacology)

Following are some of the Profiles and Key deliverables in Pharma Research & Development, Quality Assurance, Laboratory Operations and Documentation.

Research Scientist Clinical Pharmacology :

Designing, planning and executing experiments for BA / BE studies for domestic registration.

Designing, planning and executing experiments to characterize NCEs.

Planning and conducting pre - clincal safety pharmacology / toxicity studies to establish safety potential of NCEs.

Managing Capex and Opex in designated areas.

Leading a team of Scientists to build processes for synergizing interdepartmental activities.

Working closely with top management to understand business aspirations and to follow the same into various action items in areas of assigned responsibility.

 

CLINICAL RESEARCH: PHASE I / II STUDIES

Gaining extensive experience in phase i and phase ii studies for Antibacterial.

Developing Clinical / Bioanalytical protocols and work with various CROs for the completion of both phase i and phase ii clinical studies.

Handling medical writing team for preparation and submission of clinical trial report and achieve the grant of approval. Extensive experience in various regulatory guidelines.

Profiling product dossiers (safety and efficacy) for new products including generics, Biotechnology, NDDS and vaccines. Planning protocols for bio efficacy and toxicity studies carried out on New products (EPO, Hepatitis-B vaccine and Insulin analogues). Member of the corporate core group for Generics / Biogenerics and advice on Preclinical and Clinical studies for registration.

Possess very strong leadership, management and Scientific qualities.

 

Associate Vice President of Clinical Research

Designing, planning and executing experiments to characterise the preclinical pharmacokinetic profile of anti-infective NCEs (Fluoroquinolones, Oxazolidinones & Beta-lactamase inhibitors) - Serum & various tissue level determinations serum protein binding determinations metabolite determination from urine & faecal samples in vitro drug metabolism studies using pooled liver microsomes from different species of animals toxicokinetic studies in rodents & dogs.

Planning & executing safety pharmacology studies for lead NCEs establishing their safety potential viz a viz standard drugs determination of class specific effects. In-vivo QT prolongation studies in beagle dogs, rabbits and Guinea pigs, in-vitro APD measurement studies and hERG inhibition studies.

 

MANAGEMENT RESPONSIBILITIES

Overseeing divisions infrastructural resource management, capex and revenue budget management, synergise intra-departmental activities, participation in scientific meetings with top management for presentation of the data from various projects human resource management like selection of scientists for the manager and above level positions, interaction with fellow scientists on regular basis for scientific discussions, representing the Clinical group from India in meetings with different international location heads for generic and biogeneric programme.

Leading a team of Scientists, build processes for synergizing interdepartmental activities.

Working closely with top management to understand business aspirations and to follow the same into various action items in areas of assigned responsibility.

Conceptualise, design and established a 100 bed clinical facility, 10 LC/MS-MS equipped Bioanalytical lab and complete CRO structure with Data Management, PK/Biostats and Project Management Group for Wockhardts Generic (ANDA) programme.

Filing ANDA applications to FDA / MHRA and other agencies, approvals for 3 4 ANDAs.

Planning and preparing annual capital and revenue budget for BA / BE studies (Both In House and Out Source) and Manpower requirements. New Product identification along with corporate Project management and IP team.

Lead a team of 120 Scientists at the CRO working in different disciplines.

Reducing the outsourcing of Pharma Company's generic programme leading to cost saving.

Head the project management group for identification of products for ANDA filing, setting up of timelines for various projects, resource allocation to different projects, budget management and interacting with outsource CROs (National / International) for project negotiations.

 

Managing Director of Pharma Company :

Lead the organisation into managing clinical trials for various organisations from within and outside of India.

Managing performance, competence of a team of around 400+ employees, with clear focus on delivery and quality parameters.

Demanding high level of clinical and professional standards from all employees and take corrective action wherever needed.

Supervising a team of top managers and keep them aligned to business, build enabling team working for building synergies and top class performance.

Building relationships with prospective and existing clients, based on mutual respect of IPR and satisfy the client requirement of providing output at expected quality and timelines.

Focussing on revenue and costs on an ongoing basis and ensure profitability and growth of the organisation.

 

Global Chief Executive Officer

Leading the organisation into managing clinical studies for various national / international pharmaceutical companies.

Managing performance, competence of a team of around employees, with clear focus on delivery and quality parameters.

Demanding high level of clinical and professional standards from all employees and take corrective action wherever needed.

Overseeing a team of top managers and keep them aligned to business, build enabling team working for building synergies and top class performance.

Building relationships with prospective and existing clients, based on mutual respect of IPR and satisfy the client requirement of providing output at expected quality and timelines.

Focussing on revenue and costs on an ongoing basis and ensure profitability and growth of the organisation.

 

 

To Summarize following are the Areas of Expertise of Careerpath from Research Scientist to managing Director in Pharma Company :

Areas of Expertise

Research & Development

Developing formulas for new products or re-formulations using analytical methodologies.

Making prototypes of new products for physical & chemical analysis and evaluating physical & chemical compatibility of drug substances with other ingredients. Conducting clinical trials and involving the preparation of clinical trial formats.

Quality Assurance

Achieving productivity improvements & eliminating non-value added operations; ensuring compliance to various quality measures for analytical trials.

Conducting various tests & inspections to ensure that products developed are in compliance with pre-set technical specifications with adherence to quality concepts.

Laboratory Operations

Arranging periodic calibration of test equipments in the laboratory either internally or by adequately qualified personnel / agencies.

Managing routine maintenance; up keeping of the analytical equipments on a regular basis for higher productivity and efficiency.

Documentation

Making monthly reports, annual product reports & periodic product review, etc.; ensuring compliance of various quality measures by maintaining requisite documentation / records.

Preparing daily & periodic laboratory reports for information, compliance & corrective action; writing / reviewing detailed documents like process and cleaning validation protocols.

 

 

 

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