RESEARCH SCIENTIST FORMULATION @ ABBOTT
JOB TITLE : RESEARCH SCIENTIST FORMULATION
JOB FUNCTION : INNOVATION & DEVELOPMENT
LOCATION : Mumbai
REPORTING TO : Group Leader Formulation
PURPOSE:
Deliver formulations in defined timeframe to
meet product delivery goals for I&D
Development of different formulations either
as generic or differentiated generics. To demonstrate successful stability and scale
up at manufacturing site.
CORE JOB RESPONSIBILITIES
Development of formulation using scientific
rationale in use of excipients to create a reproducible prototype formulation.
Ensure Proper documentation of every trial in
the log note books and then using the information for creation of the Product
Development Report for use in dossier for filing.
Use of QbD wherever required for Product and
process optimization.
Ensure proper upkeep, maintenance and
calibration of the equipment.
Ensure scale up of the developed formulation
works at engineering batch level.
Development of the patent non-infringing
strategy for product development.
Preparation of regulatory documents for PK
study and marketing approval from DCG (I).
Preparation of Pharmaceutical Development report
for Quality module of CTD.
KEY DELIVERABLES:
Literature/Patent search to create drug
profile
Prototype development with rationale use of
excipients
Pre-formulation study as may be required for
formulation development
Conduct 6 months accelerated stability
studies to ensure stable formulation
Proof of concept studies to demonstrate BE or
comparative PK as the case may be
Scale up studies at 1/10th scale or
engineering batch
Technology transfer and manufacturing of
Bio/Clinical batch
CRITICAL SUCCESS FACTORS:
FUNCTIONAL/ TECHNICAL:
Formulation and Product Development
Schedule and follow all the steps to deliver
the drug as per QTPP
Select the suitable polymers / excipients
based on either properties or scientific rationale
Evaluation of CQA of drug / excipients and
estimate its implications for product development
Designs the process which is reproducible
and scalable with higher yield, cost effective, and environment
friendly
Plan and executes the trial to identify
Critical Process Parameters (CPP) and design the control strategy
Overcomes the limitations / problems and
effectively resolves the same
Design of Experiments
Plans and executes the experiments as per DOE
to optimize product and process
Applies basic principles of experimentation
Pharmaceutical Development Report (PDR)
Prepares PDR as per Common Technical Document
(CTD) module 3 requirements
Complies with regulatory requirements as
defined in QTPP
Project Management
Is able to plan and prioritize multiple
project deadlines to meet product delivery goals
EDUCATION & EXPERIENCE:
M. Pharm/Ph. D. 7 - 10 yrs
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