Anil Kumar Atluri (M.Sc, Mba, Pmp, Lssgb) Email and Phone Number

Responsible for New prodcut launches across the global and for Alliance Management activities

Strategic Program Management: Responsible for planning and executing departmental and program-related activities aligned with organizational goals, involving project management, budgeting, risk management, strategic planning, compliance to ensure the successful execution of programs and projects.Proactively identifying and addressing risks during the planning phase to prevent potential long-term disruptions to planned activities Cross-Functional Collaboration: Collaborates with… Show more Strategic Program Management: Responsible for planning and executing departmental and program-related activities aligned with organizational goals, involving project management, budgeting, risk management, strategic planning, compliance to ensure the successful execution of programs and projects.Proactively identifying and addressing risks during the planning phase to prevent potential long-term disruptions to planned activities Cross-Functional Collaboration: Collaborates with cross-functional teams and external partners to achieve project objectives, ensuring end-to-end management of projects and addressing commercial bottlenecks and development challenges. At a time have worked with more than 6-8 CFT.Budget Oversight and Cost Management:Manages a substantial departmental budget of $12.5 million, implementing cost management and reduction programs, and coordinating with operations to meet business requirements.Stakeholder Vendor and Partnerships Management:Identifies and collaborates with contract manufacturing (CDMOs)and testing sites(CTLS) , engages consultants, QPs and coordinates with internal and external partners in product development, filing, and launch processes.Audit readiness and Response:Identification of the external party for facility audits and support the regulatory authorities with their pre- requisites.Supported Compliance team during FDA response on audit observation.Global Leadership and Reporting: Leads and guides a team in program planning and execution, monitors key performance indicators (KPIs), and business unit metrics, and prepares management reports, presentations, and Dashboards for their management review which will be used in decision making and efficiency improvement.Recent achievements:Awarded with LSSGB for operational excellence.Played a crucial role in the Biocon and Viatris deal especially for Europe region for Contract testing site onboarding, QPs identification and onboarding, and artworks revisions. Show less

Head PMO for both R&D and Manufacturing.Drug Development and Strategic Program Management:• Responsible for planning and executing API R&D projects and manufacturing related activities aligned with organizational goals, involving project management, budgeting, risk management, strategic planning, compliance to ensure the successful execution of programs and projects.• Identifying of the new project and finalizing by discussing with CFTs and assigning to the R&D teams for… Show more Head PMO for both R&D and Manufacturing.Drug Development and Strategic Program Management:• Responsible for planning and executing API R&D projects and manufacturing related activities aligned with organizational goals, involving project management, budgeting, risk management, strategic planning, compliance to ensure the successful execution of programs and projects.• Identifying of the new project and finalizing by discussing with CFTs and assigning to the R&D teams for development.Cross-Functional Collaboration: • Collaborates with cross-functional teams and external mfg. partners to achieve project objectives, ensuring end-to-end management and ensuring that projects complete on time.• Addressing commercial bottlenecks and development challenges proactively.• Handled one or more intense collaboration with more than 3 Mfg. sites for completing single projects.Budget Oversight and Cost Management:• Manages a substantial departmental budget of Rs50 Cr implementing cost management and Cost reduction programs, and managed CFT accordingly to meet business requirements.CDMO and CTLs Management and Partnerships: • Identifies and collaborates with contract manufacturing (CDMOs)and testing sites (CTLS) and coordinates with internal and external partners in product development, filing, and launch processes.Leadership and Reporting:• Leads and guides a team in program planning and execution, monitors key performance indicators (KPIs), and business unit metrics, and prepares management reports, presentations, and Dashboards for their management review and help to derive risk mitigation, efficiency improvement, both Cost and Time.Achievements:• Successfully completed the Covid drug development projects in short span of time and delivered the material.• Successfully saved 1Cr for the company by implementing the use recycled solvents at commercial scale. Show less

PM Lead for New projects at API R&D at Mylan R&D center.Drug development and Filing:Worked on identification and proposal of New APIs for development to Senior management with entire information to build business and case for getting approval from the COO.Handled more than 25 New API (includes complex generic and Peptides) and 1 NDA molecule.Responsible for planning and executing departmental and program-related activities aligned with organizational goals, involving project… Show more PM Lead for New projects at API R&D at Mylan R&D center.Drug development and Filing:Worked on identification and proposal of New APIs for development to Senior management with entire information to build business and case for getting approval from the COO.Handled more than 25 New API (includes complex generic and Peptides) and 1 NDA molecule.Responsible for planning and executing departmental and program-related activities aligned with organizational goals, involving project management, budgeting, risk management, strategic planning, compliance to ensure the successful execution of programs and projects.Stakeholder and Cross-Functional Collaboration: Collaborates with cross-functional teams, Manufacturing sites and Customers to achieve project objectives, ensuring end-to-end management of projects and addressing development and manufacturing challenges.Budget Oversight and Cost Management:Manages a substantial departmental budget of Rs 10 Cr by implementing cost management and Cost reduction programs and make sure the budget is effectively utilized.Vendor Management and Partnerships:Identifies and collaborates with contract manufacturing (CDMOs) and coordinates with internal and external partners in product development, filing, and launch processes.Global Leadership and Reporting: Maintain the repository of the projects and their information, monitors key performance indicators (KPIs), and business unit metrics, and prepares management reports, presentations, and Dashboards for management review for decision making.Business development Support:Complete support from documentation till sample supply for promoting new product to the new customer.Preparing the Global presentation on products for business team before meeting customers and CPHI.Achievements:Bagged Annual Excellence award for end-to-end completion of NDA project till filing. Got US approval with no observations and EU with 1 minor observation. Show less

• Started Project Management role in this organization. Established PMO office in API R&D. Developed process , methodologies and procedures for project management activity. • Handled 5 yrs Budget in API R&D which is ~50 Cr per year. • Coordinated for Molecule identification, planning, tracking and execution. • Worked with CFT like IPR, RA, BD, Analytical and Formulation from identification of molecules till DMF filing. • Prepare presentation for Budget , CEO meetings, Quarterly… Show more • Started Project Management role in this organization. Established PMO office in API R&D. Developed process , methodologies and procedures for project management activity. • Handled 5 yrs Budget in API R&D which is ~50 Cr per year. • Coordinated for Molecule identification, planning, tracking and execution. • Worked with CFT like IPR, RA, BD, Analytical and Formulation from identification of molecules till DMF filing. • Prepare presentation for Budget , CEO meetings, Quarterly open house and regular department meeting. • Introduced new technique by Idea generation session with CFT and internal team when there is constrain the process and procedure. • Managing and overseeing microbiological activities and participating in projects related to the production of pharmaceutical compounds, including Lovastatin, Lipstatin, Daptomycin, Compactin, and Pravastatin. These projects advanced to the laboratory fermenter scale and even underwent pilot trials • Collaborated closely with the Fermentation Plant team to coordinate microbiology activities related to fermentation processes.• Successfully completed the development of enzymatic technologies, which were scaled up to kilo lab scale. This involved both in-house and outsourced enzyme utilization. • Played a significant role including Rosuvastatin, Sitagliptin, Valsartan, and Atazanavir. Enzymatic technologies are often used in the pharmaceutical industry for specific chemical transformations or reactions. • Ensured that all laboratory activities complied with quality standards and regulations. This likely included documentation, adherence to Good Laboratory Practices (GLP), and preparation for internal and external audits to maintain regulatory compliance.Therapeutic drugs : Statins, Nibs, Bans , Gliflozins, Glipitins, Libs, Sartans, complex compounds and Peptides. Show less

Worked as Microbiologist in PCG lab.Main role is to Screening and develop / improvement of cultures w.r.t to yield and stability. Maintaining of the strains / cultures and propagating them for development of Master Cell bank and Working Cell bank .Faced USFDA, TGA, EU GMP audit during my tenure

Worked in production seed lab where use handle commercial cultures from cell bank prapration to seed preparation for commercial batches. Along with this use to handle Quality control acitvities to given clearance for the batches, monitor sterility of the batches and finished prodcut, this lab is USFDA approved lab.