- Senior level / leadership position (for more than 10 years) with Chemical Development of API & CRAMS Divisions to handle Process Development of API (Early Phase, Late Phase & Generic API) and its Intermediate from Route Selection to Regulatory filling/Delivery to Customers including Manufacturing at kilo level to commercial scale; Project/Delivery management, providing support for Business development, Technology Transfer and Analytical research functions
Product development and manufacture/ delivery of APis for internal as well as external customers, running CRAMS business and expansion, Profit & Loss management of Site Business (both Generic API & CRAMS), project management, Process Development, manufacture and delivery of & Early phase/Late phase/ Generic APis and their Intermediates, maintaining the Customer relationship and Site Operations.
Generic APis Development projects (from route selection to validation /DMF filling) and also commercializing few Generic API and its intermediates through process absorption/Tech transfer to scale up.
Handling many internal and, external Customers projects of early Phase/ late phase APis, Generic APis and their intermediates from development to delivery including project management/execution.
Demonstrate competencies with Project & Delivery Management for CRAMS and API development activities from development to delivery (Early Phase, Late phase & Generic) for various customers from Europe, USA, Australia, Japan etc.
Support Drug Discovery & Development Program for external customers as well as internal customers.
Handle Profit & Loss of a Chemical process (API & CRAMS) business Unit/Site independently.
As part of top level management, responsible for planning and developing strategy forCompany's research activities for API business and CRAMS business, Process Development and manufacturing / delivery of Generic APis & Early phase APis/Intermediate, R & D Site Operations, providing regulatory support for DMF filling and providing technical support to Business Development Team.
Sound knowledge with cGMP, cGLP Practices and Regulatory aspects for both API & formulation development/manufacturing and actively involved in many audits of USFDA, PMDA of Japan, MHRA, TGA etc. and other Customer audits.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Engineering Design, R&D
Role Category:Senior Management
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Pharma - Pharmacy, B.Sc - Any Specialization
PG:MS/M.Sc(Science) - Chemistry, Organic Chemistry
Doctorate:Ph.D - Chemistry
With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. In house capabilities for Development of APIs, Finished Dosage forms, Formulations, Non-Infringing Process & World Class facilities for Contract Manufacturing are the inherent strengths
Ind-Swift is well placed in both developed and emerging markets. As we take our path forward in the new decade, we are well aware of the challenges that we face now and would encounter, and as a team we are geared up to make Ind-Swift Laboratories a company which gets recognition as a front runner in the Global Pharmaceutical industry.
With expertise in activities ranging from world-class contract research, process development to final production, our infrastructure offers numerous choices for cooperation. We strive to roll out of continent specific R&D programs and production campaigns, which help companies, maximize penetration of markets and garner increased revenues. Our facilities are constantly expanded and upgraded to meet the increasing demands on quality and consistency of supplies. Our manufacturing plants are accredited by international agencies such as US-FDA, TGA, UK-MHRA, UAE besides others. Our customer base has grown exponentially in key regions of the world including Europe, South America and South East Asia besides US. New projects, ventures and strategic alliances have been forged over the years based on mutual trust, reliability and client servicing.
Recruiter Name:Mr.Atul Kumar Chaubey
Contact Company:Ind Swift Laboratories Ltd.