Experience: 15 to 20 years with some exposure in CDO/CDMO space
Education: M. Pharm / Ph.D.
Job Location: Ahmedabad, Gujarat.
Skills: Proven experience in relevant role in R&D, Integrity and efficiency is a must, Out of box thinking including differentiated products, Excellent leadership and managerial skills, Good business sense, Must have regulatory knowledge besides formulation and analytical knowledge, Project Management.
Responsibilities :
Oversee and manage the entire R&D department, including formulation and analytical development functions and act as SBU head. Motivate, develop, and train scientists to achieve product development goals and maintain high-quality standards.
Drive the development of new products from concept to final launch, ensuring all technical and process details are addressed. Generic and generic plus development and managing PIND and live communications with USFDA or other reg agencies.
Ensure all R&D activities are meeting ICH guidelines, and other relevant regulations. Coordinate with the Drug Regulatory Affairs (DRA) team for filing (e.g., ANDAs) and addressing deficiencies.
Track, analyze, and control costs, schedules, and quality to achieve customer satisfaction. Review batch records, process characterization reports, validation reports, and investigation reports.
Manage the transfer of technology to and from manufacturing sites, including scale-up batch production. Assure technology transfer follows norms and standards.
Create and review procedures, documentation, and test results for accuracy and compliance with SOPs/GMP requirements. Ensure all documentation is complete and accurate for regulatory submissions.
Help identify new product opportunities for regulated markets. Develop and implement strategic plans for R&D to support business goals and stay ahead of industry trends. Lead key projects with R&D to support business goals.
Interested can share their CV to hr@apdmpharma.com with the subject line mention as "Resume for Head - R&D, Ahmedabad".
We are a worldwide network of CMOs, CDMOs, and CROs that provide pharmaceutical services. Our organization boasts over a century of CDMO experience, half a century of R&D, and decades of regulatory and quality assurance expertise. In the pharmaceutical industries in the USA, UK, EMEA, Canada, and other PICS countries, we have established ourselves as reputable, trustworthy, and value-added service providers.
Following the successful establishment of a top-tier CDO business, we have expanded into full-service CDMO and technical service providers to quicken product development, launch, or site transfer for pharmaceutical businesses in an effort to obtain a competitive advantage and larger market share. We have a great deal of expertise handling CMOs and CDOs in Asia, Europe, and the UK in order to transfer technology quickly for projects.
We can collaborate honestly and assiduously with a vast network of wonderful people and business partners. We have been in this business since the 1990s, have seen significant changes over many years, and have adjusted to make a difference.
We have competent technical staff members with the necessary training and expertise.