Head Formulation Development
Sandoz India Pvt Ltd
Localização do trabalho
Madhavaram, Telangana
Status de emprego
Tempo total
Detalhes sobre a oferta de trabalho
Job Description
Your Key Responsibilities:
• 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.
What You’ll Bring To The Role
• 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.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, innovative production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com