Strategic-thinking individual experienced in successfully engaging employees and encouraging each to reach highest potential. Technology focused professional with Goal and strategy driven attitude having an experience in delivering high priority complex projects (Level 3 innovations) in a tight regulated environment (Pharmacy, medical device & Drug - device combinations). Past experience in Pharmaceutical development as well as medical device product development with a major focus on development and technology transfer of IP-led niche products (Transdermal products, DPI's, Autoinjectors/pens, cardiovascular stents, active medical devices); with a core competence in pharmaceutical excipients, engineering, intellectual property management. Collaborative leading style with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Additional experience with IT-driven project/resource management platform has provided a significant competitive advantage in a rapidly evolving regulatory landscape. Past experience with regulatory interventions associated with CTD preparations, CE submissions within the scope of 21 CFR 820, ISO 13485, ISO 14971, Failure mode effect analysis (FMEA), Human factors of design and Quality by design (QBD) for a product as well as process optimization. Simultaneous seasoning with innovation management and medical management practices supports unique skill set of product, service and treatment / practice development within the domain of pharmacy and medical devices.
Outline:
Nanotherapeutics Pvt. Ltd is an ISO 13485:2016 and ISO 9001:2015 medical device manufacturer since 2011 and primarily catering to the cardiology sector with HQ in Surat, Gujrat, and sales network pan-India. Mainly working in Class II/III devices (high-risk devices - both implantable as well as non-implantable active devices) and exporting stents and stent assemblies with CE certification.
Key Responsibilities:
1. Led a team of engineers & scientists to new product development (NPD) catering to the minimal surgical intervention segment. Stakeholder management at C-suite level as HOD of R & D.
2. Draw growth-oriented R & D program towards enhancement of skills, capabilities, and building resilience (with i3 approach). Change the R & D roadmap from a discovery approach to a systematic approach involving FTO & Patentability searches.
3. Plan & Execute IP basket management in a radial manner (Flower type).
4. Implementation of EU MDR 2017 compliance, Risk management and mitigation plan (ISO 14971), 21 CFR 820 (QMS), 21CFR 11 (electronic document trail), Usability engineering (human factors of engineering), Toxicological risk assessment, Safety and EMC aspects of medical devices (IEC 60601).
5. Product development - Balloon expandable covered stent, Intravascular lithotripsy, heart pump, Bronchial thermoplasty, Dural sealant, Aneurysm device, Occluder device (both atrial & ventricular septal defect closures).
6. Implementation of Project management module with SAP B1 / HANA. Planned & executed budget as per cost center allocations as well as managed profit & loss accountability for R & D projects.
7. Updated policies to reflect changing conditions and maintain optimal safety standards for all employees.
Key achievements:
1. Created an IP basket with patent, and copyright transfers associated with open-source software and industrial design registrations.
2. Delivered a unique composition of API's & chemicals to provide the least post-surgical effects (10% re-stenosis against 40 % re-stenosis associated with current standard clinical practice).
3. Achieved financial objectives by preparing annual budgets, scheduling expenditures, analyzing variances and initiating corrective actions.
Outline:
IIT Bombay is a premier educational and research institute. IIT Bombay is pursuing research that makes a difference. It aids in the development of human capital as well as catalyzes the integration of life sciences with engineering disciplines thereby translating technologies into products.
Key responsibilities:
1. Led cross-functional team through design, construction & development of microneedles for contraceptive application (10 people involving 4 Ph.D. candidates, a mechanical engineer, a market research team, and a GLP-certified pre-clinical toxicity center). (Funding - Bill and Melinda Gates Foundation, fund size - USD 1 million)
2. Project management (with Microsoft Excel) - Planning, designing & scheduling phases for the projects, International stakeholder management (the US, Europe & India), Budget and resource planning. Planning finance for periodic cash flow and external collaborative activities.
3. Use of innovative Design Thinking approach for new product development (human-centered design approach + Focused group discussion method / Deep interview method). People management for user needs study.
4. Providing detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
5. Planning & Executing IP strategy, portfolio & management for Microneedle technology, and patent licensing of previously developed technologies like nanobubbles for diagnostic applications & Technology transfer for the same.
6. Development of the team as well as interpersonal skills for the team for collaborative development of the project with predetermined specifications.
7. Planning & Communication of global user feedback study in Vietnam, Ghana & Brazil (Emerging markets).
8. Modified and directed project plans to meet organizational needs on the ross roads of material science, engineering & medicines.
Key Achievements:
1. A small painless microneedle patch was developed for the application of contraceptives for a period of 6 months. Platform technology is extending toward vaccine delivery as well. Patent protection in India, as well as outside India, is in progress. Simultaneously a liposome technology was transferred (Capacity 300 Ltr) using an ultra-high-pressure homogenization method (>30,000 psi for high solid contents).
2. Orchestrated projects within strict timeframes and budget constraints by solving complex problems independently associated with identification of service providers, vendors, partners and working closely with senior leaders.
Outline:
The exposure includes turnkey solutions compassing Pharmaceutical R & D to High output productions for encapsulation solutions as well as technically complex pharmaceutical products (Drug + Device combinations)
Key responsibilities:
1. Ensure development and product safety with a mindset and actions that are geared towards a consultative approach for Capsule filling, Autoinjector/pen (assembly automation), and web converting (Transdermal patches/wound care products / Oral films).
2. Project management with Kanban methodology to maintain real-time communication of capacity and full transparency of development work. Product characterization and support in the selection of recipe variants.
3. Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and common goals.
4. Cross-training of existing employees to maximize team agility and performance.
5. Development and maintenance of relationships with customers and new services through account development.
3. International stakeholder management for South Asian markets Including India, Bangladesh & Nepal. Communication & appraisals of the customer's voice with HQ in Germany.
4. Statistic trial planning (DoE) and evaluation of trial series. Feasibility studies to choose optimal processing variants. Writing and Compiling test logs and reports for development documentation and regulatory compliance (mainly US & Europe).
5. End-to-end manufacturing support for Scale-up samples for analyses and stability tests and upscaling of processes. Implementing & monitoring feedback from customers as well as process change management.
Key Achievements:
1. Successful integration of encapsulation solutions (
2. Accomplished multiple tasks within established timeframes.
3. Applied customer feedback to develop process improvements and support long-term business needs.
Outline:
With expertise in dermatological formulation development, providing innovative and sustainable turnkey solutions Mascot Universal is the leading supplier of Silicone's for pharmaceutical and biotech processing, silicone fluids for medical device fabrication and lubrication, simethicone for pharmaceutical and biotech processing, and silicone adhesives for wound care and scar care applications in India.
Key responsibilities:
1. Technical role involving Application and Innovation for Dow corning silicone's, Croda surfactants, and DSM actives along with solving customer problems for India, South east Asia & Middle east markets (Including HALAL certifications)
2. Technical services for Transdermal patches, Semisolid dosage forms, and intellectual property protection for the same. Data analysis for freedom to operate (FTO) searches as well as patentability searches towards IP Management. Planning & Execution of IP strategy for value-added commercialization of newly developed products.
3. Analytical method development and validation, Regulatory compliance activities (Dossier preparation, Quality compliance).
4. Planning & execution for Pilot plant scale-up batches (up to 10 kg). Writing SOP's & technology transfer protocols & communication with Customers.
5. Clinical testing at Mascot Spincontrol to support product claims for safety and efficacy.
6. Collaborative teamwork toward solving issues at the customer sites with special emphasis on active listening.
7. Preparing variety of different written communications, reports and documents. Conducted research, gathered information from multiple sources and presented results for patents, clinical studies as well as product development.
8. Delivering services to customer locations within specific timeframes.
Key Achievements:
Successfully developed multiple drug combination products involving steroids and vitamins. Accomplished patent for proprietary technology of anhydrous formulations. Resolved conflicts and negotiated mutually beneficial agreements between parties.
Outline:
Apart from higher education management, Institute is a key partner for various industrial and government developmental projects. Many of these have been realized in pharmaceutical as well as chemical technology sectors both inside and outside India.
Key responsibilities:
1. Performing scientific research on multiple projects - Development of three drugs, bilayered antidiabetic tablets for a CIS market specifically an Ukrainian sponsor along with other antihyperlipidemic API's.
2. Development of complex injectables for immunosuppressive ingredients.
3. Development of topical liposome formulation comprising analgesic and anti-infective ingredients for the domestic market.
4. Solving the manufacturing problems for a narcotic transdermal patch intended for a European market for an Indian sponsor.
5. Assessment of in-vitro in-vivo correlation for scale-up and post-approval changes for topical and transdermal products.
6. Writing project proposals for various government funding agencies.
7. Scientific database handled - STN, Questel - Orbit intelligence, Web of Science, SciFinder, Knovel, Science direct, Reaxys, Scopus, Clinical key.
8. Software's handled - Origin Pro 8.0, MATLAB, Empower,
Key achievements:
1. The work experience concluded with the grant of patents (2 No.) and technology transfers (4 No.).
2. Generated & authored high-quality, peer reviewed, professional papers for submission to scientific publications (4 No). Presented talk at BABE 2014 Conference, Beijing, China
3. Won research grants (CSIR, Bayer) and completed industry studies funded by corporate groups (Kusum Healthcare, Rusan Pharma, Raptim Research).
Written communication
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1. American Chemical society (Sep 2021 - till date)
2. Product Development & Management association (July 2021 - till date)
3. Royal Society of Medicine (January 2021 - till date)
4. IEEE Engineering in Medicines & Biology society (Jan 2021 - till date)
Publications:
1. Amarjitsing Rajput, Riyaz Ali M Osmani, Achyut Khire, Sanket Jaiswal, Rinti Banerjee," Levonorgestrel Microneedle Array Patch for Sustained Release Contraception: Formulation, Optimization and In Vivo Characterization ", Molecules, 27 (7), 2349. DOI: 10.3390/molecules27072349
2. Achyut Khire, Pradeep Vavia," Effect of permeation enhancers on dynamic mechanical properties of acrylate pressure sensitive adhesives ", Int. J. Pharm., 458 (1), 141 - 147. DOI: 10.1016/j.ijpharm.2013.09.037
3. Achyut Khire, Pradeep Vavia," Bioavailability, bioequivalence, and in vitro–in vivo correlation of oxybutynin transdermal patch in rabbits ", Drug Del Trans Res, 4 (2), 105 - 115. DOI: 10.1007/s13346-013-0170-y
4. Gaurav Subhash Yeola, Sharad Darandale, Achyut Khire, Pradeep R Vavia ," Fabrication and statistical optimization of a polysaccharide-based sublingual film of buprenorphine hydrochloride for breakthrough pain management: in vitro and in vivo performance ", Drug Del Trans Res, 4 (2) 116 -125. DOI:10.1007/s13346-013-0183-6
5. Achyut Khire, Pradeep Vavia," Electron capture detection of oxybutynin in plasma: precolumn derivatization approach and application to a pharmacokinetic study ", Analytical Methods, 6 (5) 1455 - 1461. DOI: 10.1039/C3AY41796D
Presentation:
1. 4th World Congress on Bioavailability and Bioequivalence: Pharmaceutical R&D Summit A Khire, P Vavia - 2013
Patents:
1.
1. (Granted) IN 285298 : Pharmaceutical Composition Containing Acrylate Type Aqueous Based Pressure Sensitive Adhesive For Transdermal Drug Delivery
2. (Granted) IN 291817 : Novel silicone pressure sensitive adhesive composition for transdermal drug delivery
3. (Filed) US 17/060,352 and IN 202021016878 : MICRONEEDLE ARRAY PATCH FOR DRUG DELIVERY AND PRODUCTION METHOD THEREOF
4. (Filed) PCT/IN2022/051132 and IN 202121029892: DIRECTIONAL AND TEMPORAL RELEASE OF DRUGS FROM MEDICAL DEVICES