PHARMA WISDOM

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

Research Officer / Research Associate @ Glenmark Pharmaceuticals Ltd

Experience: 4-6 yrs

Location: Nasik

Roles and Responsibilities

• Literature and patent search

• Competitor product procurement and characterization

• Pre - formulation development

• Evaluation/optimization of excipients and primary packaging

• Materials

• Bill of material and Master formula card Preparation

• Process Finalization

• Stability studies and report writing

• finished product specifications finalization

• Scale-up study and process comparison

• Pharmaceutical development report writing

• Technology transfer of the product at Plants

• Exhibit Batches at Plant (as per the Requirement of Regulatory)

• Process development report

• Investigation and Reformulation on complaints

Desired Candidate Profile

Candidate should have experience of minimum 4-6 years in MDI dosage form .Should be well conversant with commercialization of few formulations in MDI dosage for India/ROW or regulated market.

Keep the above Job Description matching with profile please send your updated CV at Bhushan.Wadgaonkar@glenmarkpharma.com / Dhurjuti.Dhibar@glenmarkpharma.com