|
Strategic and planning
- Alignment of the R&D initiatives with overall strategic plans.
- Review and approve the product development plan (includes timelines, product features, quality requirements)
- Prepare budgets for development- new product and infrastructure.
- Prepare plan for business opportunities through innovation
- Support and drive initiatives of reliability and solutioning
Functional
Formulation Interface:
- Ensure resolution of customer challenges related to incompatibility of capsules and formulation
- Interact with customers for technical discussions related to customer challenges
- Ensure compliance to various pharmaceutical equivalent and dissolution tests to validate the customer challenges and identifies the root cause it. (Suggests ways to resolve the customer complaint either by recommending changes in the capsule process or changes in the customer’s formulation that is being used)
- Design and execution of experimental plan, review of analysed data to draw a conclusion and make recommendations.
- In depth experience of handling oral dosage forms like Tablet, Capsules, soft gelatin for regulated market for ANDA submission and marketing authorization, with minimum 12-15 product filings.
- Comprehensive knowledge of regulatory requirement/compliance in global market, i.e. US, Europe, Brazil, Canada etc.
- Well updated on the current trends, practises, development and regulatory changes which can impact products, procedure or formulations.
- Good knowledge on manufacturing equipment and technology transfer.
- Interaction with CROs, CMOs and pharmaceutical manufacturer when needed
- Collaboration and joint development with universities and key customers to support innovations in Pharma Nutra landscape
- Ability to conceptualise and develop new pharmaceutical product formuklations/segmented solution with capsule variants through complex generics and 505 B2 route.
White Papers/Patents Filing:
- Drive the work related to patents filing/white paper publication on the various developments/improvements related to the product in order to strengthen the credibility of ACG in the pharmaceutical and nutraceutical space.
- Minimum 6-8 scientific publications should be published with the name on international platform
- Work closely with New Product Engineering team to obtain a detailed understanding of the characteristics of various new products identified/new products under development
- Advise various tests to be performed by the new product development team in order to generate data to support claims required while filing patents or publishing white papers/product launch
- Work with various domestic and international attorneys to file patents through ACG Patent Cell
- Identifies improvements/customizations in order to file patents/publish white papers for capsule products, capsule process/technology
- Well experienced in public relation with demonstrating the skill of delivering product and application knowledge to the pharmaceutical customers
- Experience in webinar/seminar delivery on international conferences and workshops.
Competitor Analysis and strategy planning for pharma development:
- Scan the external environment (pharmaceutical industry, competitors) to identify potential areas of growth through product / process technology innovation
- Regularly monitors the R&D initiatives taken by the competitors and the patents applied for in the capsule industry
- Monitors closely new trends within the pharmaceutical space and identifies the opportunities for innovation at our end
- Evaluates the identified opportunities considering the cost benefit analysis, its strategic implications by doing further research. Categorizes the identified opportunities using a SWOT analysis and accordingly creates an action plan for R&D implementation
- Works with various universities, international pharma experts to develop new features in our existing products by using the lab infrastructure facilities available at these universities or with these experts
- Maintains and establishes a professional network in the pharmaceutical space by attending various seminars and conferences
Generating business leads:
- Work closely with the R&D scientists of various pharmaceutical companies and provides solutions to their R&D team by customizing our product features
- Explore opportunity for ACG’s business expansion with pharma customers by providing value addition to their product
Internal Processes:
- Liaison with operations, Quality, Product Managers, Plant Operations, New product development, Key Account Managers, and Scientific application services teams etc
People development:
- Take overall responsibility for people development initiatives and building up in-house capabilities for the employees in the team
- Drive a performance driven culture in the team by timely monitoring, review of performance parameters and feedback to the team members
- Contribute towards development of talent of the team by providing subordinates with adequate exposure and growth opportunities to enable readiness for higher roles
- Actively participate in HR initiatives to drive overall employee engagement and motivation
Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.
|
