Research
Associate - pMDI Analytical Research & Development
Company: Glenmark Pharmaceuticals Ltd, Nashik
Candidate should have 3-4 years Experience in Analytical
Development of pMDI and DPI products
Roles &
Responsibilities
The role primarily involves support to various activities that are involved in
Analytical Development process for pressurized Metered Dosage Inhalers (pMDI).
It may occasionally support Analytical Development process for other dosage
forms like DPI for different Markets. Also frequently visit Manufacturing
plants / site for technology transfer and validation support. The goal of this
role is to deliver services with Accuracy in results and within timelines
agreed with Group leader.
Below listed are broad deliverables / responsibilities of the role:
- Initial
Sample Analysis - Analysis for Assay, Related substance, APSD and DCU
analysis.
- Characterization
Study and In vitro study support at site
- Technology
Transfer and Validation support at site
- Calibration
and qualification of Instruments
- Working
Standard preparation & Standardization, API analysis.
Desired
Candidate Profile
Education M.Pharm - Pharmaceutics Chemistry / Ph. D / M.Sc.
Analytical Chemistry
Experience
Should have 3-4 years Experience in Analytical Development of pMDI and
DPI products
- In
Process, Stability and Finished Product analysis: Assay, Emitted Dose,
DCU, APSD, Spray pattern etc.
- Preparation
of specification, Stability compilation Report
- Technology
Transfer experience at GMP site
Knowledge
and Skills (Functional / Technical)
Should be well acquainted with handling below equipment:
- High
Performance liquid chromatography (HPLC) / GC (Gas Chromatography)
- MDI
ACS / MDI FD-10 system Auto actuation system
- ACI
(Anderson Cascade Impactor) & NGI (Next Generation Impactor)
- Malvern
Particle size Analysis
- Coulometer
for Water content
- Other
common instruments (Micro balance / UV spectrometer / FTIR etc.)
Leadership /
Managerial Attributes
Team Player
Other
requirements (licenses, certifications, specialized
training)
- Familiar
with Empower software and custom field calculation
- Experience
in handling ANDA
- Ensuring
adherence to GLP.
- Effective
communicator
- Should
be willing to travel if required for tech transfer process.
Interested candidates may send their updated CVs on Bhushan.Wadgaonkar@glenmarkpharma.com
and Dhurjuti.Dhibar@glenmarkpharma.com
Each team member has a diverse skill set web design in that serves a purpose for every phase of the project and works diligently…
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