Team Member - Primary Packing Development

InvaGen Pharmaceuticals Inc; Maharashtra; On-site; INR 2,800,000 - 4,000,000; Full time

Job summary

InvaGen Pharmaceuticals Inc. is seeking an experienced Packaging Development Leader to drive cost-effective packaging solutions for new formulations.

You will oversee the selection of packaging components, supplier management, and compliance with regulatory submission requirements, ensuring packaging quality and machinability across multiple dosage forms. The role requires extensive hands-on experience in packaging development, strong cross-functional collaboration, and a proven track record in

Qualifications

• 12-15 years of experience in packaging material development and packaging machinery
• Experience in setting up quality test procedures
• Diploma in Packaging technology preferred

Responsibilities

• Monitor and approve innovator packaging characterization and recommend packaging components for new product formulations
• Select approved packaging vendors and ensure timely delivery of components
• Review machine trials and packing performance to approve packaging suitability and machinability
• Approve specifications for physical and chemical quality test parameters for regulatory batches
• Review technical documentation to support timely regulatory submissions
• Coordinate with Regulatory, Legal, Analytical, Supply Chain and Manufacturing teams for compliant packaging development

Skills

Packaging development

Vendor management

Regulatory submissions

Cross-functional collaboration

Documentation review

Education

B.Sc. with Diploma in Packaging technology

Job description

Job Description:

Division

Department

Sub Department 1

Job Purpose

Lead and monitor all activities related to the development of cost effective packaging system and primary packaging components for new product formulations which offers optimum product protection throughout their shelf‑life and its sustainability, and to deliver appropriate solution in terms of packaging to the ultimate consumer

Key Accountabilities (1/6)

Monitor and approve innovator packaging characterization and recommend packaging components for new product formulation by selecting the approved vendor for providing appropriate sustainable and cost effective packaging system

• Approve physical and chemical characteristics of the innovator and proposed packing components to provide technical details to the formulator for the purpose of arranging product pack stability
• Select the approved packaging vendors
• Approve the recommendation of the final packing component as given by the Group Member

Key Accountabilities (2/6)

Monitor and approve the activities of arranging packaging components from approved suppliers for conducting stability studies at R&D and machine trial at the manufacturing location within timelines

• Review and approve commercial aspects such as Cost, MOQ and lead‑time of the component; communicate the same to the marketing team for approval
• Ensure delivery of the desired packaging components in appropriate and timely manner by following up with the Group Member
• Monitor and ensure the receipt of required documentations along with the consignment for regulatory submissions by following up with the Group Member

Key Accountabilities (3/6)

Review the machine trial at the manufacturing location and finish pack performance as per the set test protocol in order to approve packaging suitability and machinability

• Review and evaluate test protocol for machine trial and pack performance
• Review the test protocol for conformance with the manufacturing location and R&D as provided by the Group Member

Key Accountabilities (4/6)

Approve specification for physical and chemical quality test parameters in order to release the packaging material for exhibit / regulatory batches at the manufacturing location

• Review and approve SAP code; Packaging Material Specifications and PM QC specifications prepared by team members for technical parameters and to process further with cross functional (RA, CQA, Manufacturing) departments for their consent

Key Accountabilities (5/6)

Review and approve technical documentation as submitted by the Group Member to facilitate timely regulatory submission of the documents

• Approve documentation related to extractable data to be submitted to ADL for analysis; Certificate of Analysis ; Drawings; Material safety data sheet; validation reports; Technical data sheets; compliance certifications; DMF LOA etc. to be submitted to RA for final submission

Major Challenges

• Resource constraint to the team catering all the dosage form leading to higher workload
• Aligning the job activities with cross functional teams to avoid delay in work process
• Overcome by: having face to face meeting with CFT

Key Interactions (1/2)

Internal

• Regulatory department for determining and facilitating packaging regulatory requirement (monthly)
• Legal department to obtain Patent information on packaging ( yearly)
• Analytical department for testing packaging components ( monthly)
• Supply chain for development packaging components and specifications from the supplier (weekly)
• Business Development for packing design approval(Quarterly )
• Manufacturing unit for machine trial ( monthly )
• Accounts department for follow up payments of PM testing laboratories ( monthly)
• Technical services for machine trial ( quarterly )
• CQA and DQA for PMS and change control review ( weekly)
• SAP team for material code ( weekly)

Key Interactions (2/2)

External

• Packaging Component Suppliers for development new packaging components and samples for trial ( weekly)
• Packaging Machine suppliers for new machine/ change parts requirement ( yearly)
• PM testing laboratories for sample analysis ( monthly)

Dimensions (1/2)

• Responsible for 5 dosage form (Solid / Liquid oral ; Topical; CHC; Veterinary product dosage form)

• Total projects in hand per annum: ~60

Key Decisions (1/2)

Decisions

• Selection of Packaging components and Vendor to the supply chain
• Selection of packing machine and testing instruments to the technical services team
• Addition of test methods in QC specifications to the manufacturing unit

Education Qualification

B.Sc. with Diploma in Packaging technology from Recognized Packaging Institute

Relevant Work Experience

12-15 years of experience in packaging material development / packing machineries/ setting up quality test procedures