Job
Description
Summary Within Kidney Care RD, manages a diverse team of scientists that specialize in analytical chemistry and stability as applied to drug products and medical devices product to support global product development activities, sustaining product operations, and RD Stabilities studies. Utilizes solid understanding of theories and practices of a variety of disciplines to manage complex projects or programs within boundaries of quality, time and budget. Based on significant expertise in chemistry and chromatography, other analytical techniques, design, review and/or approve complex study design concepts or assessments and provides general direction to staff. The product portfolios supported by this team encompass Kidney Care for Chronic Kidney Disease, including peritoneal dialysis and hemodialysis, as well as Acute Therapies. Essential Duties and Responsibilities Lead the Analytical Chemistry and Stability (ACS) team in India. The team will provide technical expertise, know-how, and consulting to support Kidney Care RD as well as manufacturing facilities in terms of new technology, troubleshooting, and firefights. The team will provide analytical leadership for projects across the product life cycle and Chronic Kidney and Acute Therapy portfolios. Work closely with global ACS team members within Kidney Co. RD to define scope of work on projects as well as define execute global strategy for talent development, capability capacity for ACS organization. Select, develop and retain team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance. Solve problems expeditiously through the use of multiple disciplines and technical principles. Work collaboratively and effectively across global ACS and adjacent technical functions, e.g., Biocompatibility, Extractables Leachables, Materials Science, Microscopy and Particle Analysis leads). Support Analytical Chemistry Lab function for smooth operation. Work collaboratively and effectively with project management office, sustaining product and new product development leads, Regulatory Affairs, Quality Assurance, and other business partners as needed. Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc. Ensure timely completion of training by team members. Develop project schedules and manage project budgets for internal and external activities, as required. Employ project management tools to manage those project schedules. Be accountable for team s successful completion of projects/tasks and for meeting agreed upon milestones. Review and apply best practices and team processes and improve operational efficiency, resolve issues, improve project timelines, and make timely, risk-based decisions. Solicit regular input from customers and take appropriate action. Proactively prioritize and balance utilization of resources allocated to project. Develop recommendations for outside resources as required for the team/ project, present internal vs. external analysis. Attend project review and core team meetings, as necessary. Build a professional network both internally and external to the business. Maintain knowledge of relevant Quality System Regulations and safety requirements while building knowledge of other regulatory requirements related to Renal RD (product development, design, safety) to ensure compliance in all research, data collection and reporting activities. Qualifications Knowledgeable in Analytical Chemistry, RD Stability, and related disciplines in particular analytical methods for pharmaceutical industry. Ability to deeply engage and critically review technical aspects of analytical method assessments. Validations, transfers, stability planning, and investigations. Ability to lead teams of SMEs / technical experts in above-mentioned technical disciplines. Must demonstrate strategic leadership and proficient supervisory skills. Capable of independently analyzing and solving complex problems through innovative thought and experience, as well as project management tools Ability to oversee and implement projects/studies outside area of expertise. Communicate effectively using a wide variety of skills and vehicles and to various audiences including senior management. Display ability to communicate effectively using a wide variety of skills and vehicles and to various audiences including senior management. Demonstrate strategic leadership and proficient supervisory skills. Ability to manage multiple cross-functional teams simultaneously. Ability to lead, guide and coach scientists working in cross-functional project teams. Functional understanding of cGxPs, FDA guidelines and Quality systems Education Masters degree in chemistry, pharmaceutical sciences, or related disciplines with minimum 12 years of relevant experience (or Ph.D. with minimum 10 years experience) in pharma or medical devices industry
