Cadila Pharma

Principal task and Responsibilities:\

Ensure availability of NPD from portfolio team before initiation of project.
To identify the resource requirement for the projects such as materials, manpower, machine change parts as well
as to assimilate all the literature information collected by project teams and ensure appropriate usage throughout
development.
To lead the team for formulation design, process optimization of new formulations by investigating characteristics
of API and its viability, safety and compatibility with other ingredients, defining the material characteristics,
performing required testing, and conducting scale up studies.
To effectively plan & coordinate execution of lab scale up/ optimization and pilot BE batches by ensuring strict
adherence to lab GMP system and practices.
Planning, execution, and documentation of laboratory and pilot plant scale drug product batches.
Responsible to deliver assigned projects on time, within scope, within budget and with quality.
Organizing and presenting project kick-off meetings and stage gate review meetings.
Coordinating with RA/Finance for licensing activities.
To decide project timelines and monitor it throughout the project for timely completion.
Participate in discussion with CFT to develop an effective strategy for drug product development, IP, Bio etc.
Timely review of lab experiment notebooks as well as preparation, review of technology transfer documents and
optimized regulatory documents for regulated and domestic markets, including Module 3.2.P.2.
To coordinate with technology transfer team / production team of respective manufacturing site to ensure seamless
technology transfer by executing plant scale-up and exhibit batches as well as to review batch manufacturing and
process validation documents.
To check the stability protocols, monitor stability studies and evaluate/interpret the results to advance further for
product development activity accordingly.
To execute alternate vendor development programs as on when required by planning lab feasibility batches as well
as preparing and reviewing relevant technology transfer documents. 
Facilitated cross-functional strategy discussions covering drug product development, intellectual property, and
bioequivalence.

FORM NO. FHR005-01/05 Page 2 of 2
Delivered project updates through presentations to internal and external stakeholders, via physically presentation and
MS Teams presentation.

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