Head - Packaging - IPDO

Qualifications, Experience , Skills & Attributes:

- PG in Engineering/ Pharmacy or science background with a post grad diploma or degree in packaging technology from reputed institutes. Participation in international/ national packaging exhibitions & branding awards would be an added advantage.

- 20+ years of experience in a multi-product / multi market / integrated pharma space preferably. Patents or white papers published on packaging development / devices/ container closures would be an added advantage.

- Expertise in Primary, secondary & tertiary packaging and shipping / transportation aspects across various dosage forms, including but not limited to injectable, complex injectable, devices, pMDI, Nasal Sprays, transdermal patches, topical applications like creams, ointments, creams, foams, Ophthalmic & Otic applications, conventional oral solid dosages, APIs(Solids & Liquids) , intermediates , oral liquids , across various storage conditions, cold chain etc.

- Must have handled a team size of 30 + packaging teams handling multiple geographies from selection to commercialization. Must have held a leadership role in a leading pharmaceutical/ nutraceutical/ healthcare company, preferably in the capacity of packaging head from development to commercialization.

Job Summary:

To lead the packaging commercialization efforts for OTC store brand business, local market requirements for RX. Develop, implement and manage electronic document/art management system with integrated capabilities for project management activities and business tools to ensure compliance and improve organizational output without additional headcount. Support new business development teams to identify options, cost effective ways to produce and package possible new product opportunities.

Roles & Responsibilities :

Functional Specifications:

- Thorough understanding of development life cycle and role a packaging development team plays in carefully aligning the container closures across the lifecycle of a project

- Understanding third party operations, evaluation of CMOs/ Partners from packaging perspective would be an essential skill

- Understanding of various testing aspects (State of the art conventional formulations, leak tests, sterile applications, CCIT, Dose accuracy; DDCP & components & other niche technology) would be essential.

- Understanding DDCP, DHF & exposure to 510K & device regulations across various markets (Regulated & emerging aspects), licenses etc would be critical.

- Must be an expert in packaging development & have a thorough grooming in generic, branded formulations, Drug substances, Nutraceutical packaging.

- Understanding of various testing aspects (State of the art conventional formulations, leak tests, sterile applications, CCIT, Dose accuracy; DDCP & components & other niche technology) would be essential.

Regulatory Compliance

- Design subject matter experts on OTC and RX packaging to meet regulatory requirements for child resistant and tamper evident standards.

- Lead the third-party testing process, evaluate results, and implement a repeatable packaging standard.

- Expertise in branding & compliance packaging would be an added advantage.

- Adequate regulatory knowledge & labelling /IP/DMF /Facility compliance know how a must.

Process Improvement & Cost Optimization

- Evaluate opportunities to improve packaging line performance and recommend changes to equipment, materials, components, set-up procedures, etc. to standardize packaging components, specifications and part numbers.

- Thorough understanding of CC/PC/PL and packaging costs and impacts on product COGS.

Innovative Packaging Solutions

- Investigate opportunities to provide enhanced value to customers, increase profit or reduce environmental impact through improved material specifications or conformance.

- Conduct studies, Analyze products, and coordinate internal or outside technical resources.

- Develop packaging options that drive competitive advantage for DRL by remaining relevant to customer through innovation and differentiation.

Packaging Artwork Development

- Oversee customer-specific packaging artwork for cartons, labels and inserts in accordance with regulatory and customer requirements. Interface with customers and graphics design/printed components vendors.

- Identify and implement automated digital solution for artwork approval processing and document control.

- Design center of excellence with graphic resource and expand offerings to include advertisement, promotions, and in-store material development.

- Thorough understanding of plant packaging machinery

Packaging Material Science

- Research, understand and to be subject matter expert in qualification of primary and secondary/tertiary packaging systems.

- Execute testing as needed to support development and submission activities: USP testing; extractable & leachable; shipping tests; child resistance; line and component validation.

Vendor Management

- Establish standards and requirements for third-party co-packer's equipment to support current and future capabilities required to execute commercialization portfolio.

- Conduct ongoing vendor site visits to monitor packaging activities taking place.

- Vendors know how & vendor management would be critical - Machinery/ Packaging / testing labs / testing instruments & packaging components (Primary, Sec, Tertiary, Pallets, Cold chain samples etc)

Process Improvement

- Evaluate opportunities to improve processes to eliminate inefficiency and redundancy, streamline tasks and make effective use of limited resources.

- Optimize activities to reduce complexity, use project management tools and techniques.

- Sound knowledge for optimize and reduce the packaging costs and the costs associated with project implementation. In addition, optimize use of resources.