Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.
Post : Head Formulation Development
Job Description
• Lead and manage the India SDC Formulation team Implement respective parts of the global & local SDC strategy in the department locally and translate it into actions. Sets, communicates and aligns meaningful aspirations in terms of competitiveness and key drivers, translating them in consistent and prioritized targets and plans for the organization (fillings, launches, etc.).
• Support associates in translation of SDC objectives (fillings, launches) into cross departmental project plans. Ensure that department resources are optimized (i.e. FTE, budget, capabilities) and in line with the business need to ensure cross-departmentally agreed timelines and key milestones are successfully met.
• Plan, implement and evaluate experiments for establishing of composition, manufacturing procedures and packaging via support of def. evaluation experiments taking product stability, bioequivalence and possible production site into consideration. Screen of literature and patent situation and assess the significance on the development activities.
• Develops new and unique ideas and strives for innovative solutions. Implement and monitor quality related topics within the department (e.g. QBD), support the local quality plan in close collaboration with Quality management. Review and approve quality-related documents (e.g. development reports, transfer documents, etc.); ensure data traceability from project start to launch.
• Support dossier compilation through close collaboration with Regulatory affairs department. Provide technical support during product registration phase through responding to deficiency letters and complaints in a timely manner.
• Provide support as required during internal and external audits and inspections. Proactive development of key competencies to comply with anticipated development trends and regulations and to ensure objectives are met or overachieved. Drive top-level talent acquisition, succession planning and development of all associates within the department Actively coach and partner with direct reports to build and implement their development plans.
• Systematically sets clear expectations and fosters mutual collaboration, transparency, integrated alignment and quality of interactions as a desired operating behavioral model Consistently applies adequate consequence management to incentivize and recognize positive contributions Ensure compliance with cGmP and GDP, all relevant SOPs and reg. requirements.
Candidate Profile
• Basic degree in scientific or relevant discipline. Desirable: Advanced degree in scientific or relevant discipline (PhD or equivalent).
• Fluent in English Local language is a plus Minimum 8 years relevant experience in pharmaceutical development and good knowledge of current analytical methods.
• Broad understanding of generic drug product development and sound understanding in the area of tasks and responsibility.
• Detailed knowledge of cGMPs, quality management, regulatory guidelines as well as relevant safety and environmental regulations Strong leadership and written/verbal communication skills Basic knowledge in finance and business planning Develops high quality solutions to complex technical challenges. Innovative and Creative: strives for innovative solutions.
Additional Information
Qualification : Basic degree
Location : Telangana (Sandoz)
Industry Type : Pharma / Healthcare / Clinical research
Job ID : REQ-10020860
End Date : 30th November 2024
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