Resume of Research and Development Manager (Pharma) in Text Format
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RESEARCH AND DEVELOPMENT MANAGER - leveraging 9+ years of experience
Certified management professional with a consistent contribution in the Pharma industry as R&D Manager. Delivers reliable and high-quality project management services to enable team and project success by being strategic in project planning, team management and process management. Facilitates cross-functional planning of activities across departments and proactively identifies potential risks, resource constraints, and conflicts through a comprehensive understanding of drug development at all stages across research and development.
- Well-versed with clinical research and processes (GCPs) along with a good understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
- Excels at leading teams to deliver critical milestones.
- Ability to collaborate across different functions to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc.). and to meet business objectives.
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
- Process Improvement
- Regulatory Compliance
- Product Development
- Project Management
- Manufacturing Management
- Cross-functional Team Leadership
- Clinical Pharma Development
- Continuous Improvement
GSK, New Delhi | Jan. 2018 – Present
Senior R&D Manager
- Lead group of project and program managers, mentor them and ensure best PDP practices are followed. Responsible for surgical NPD portfolio in terms of quality, time and cost of delivery of products to the market.
- Develop & direct strategic planning of multiple projects. Ensure uniformity in execution, documentation and standards across all projects Champion and lead projects as a project manager for ophthalmic medical device products, when necessary.
- Assure design control compliance to all current quality system requirements. Identify and negotiate functional resources to assemble an appropriate cross-functional project team.
- Coordinate with Commercial and key project team members to interact with end users to gather VOC toward product design and development.
- Lead the development and implementation of a project plan, schedule, budget and capital plan as required. Prepare and amended budget forecasts as required.
- Communicate effectively with R&D management, Commercial, Quality and Regulatory and other necessary functions regarding the status of all activities and align them to project deliverables.
- Inform management in a timely manner of any problems which may result in a delay in project schedules so that appropriate action may be taken.
- Identify means to minimize impact on the project.
- Plan, coordinate, & conduct formal and informal portfolio reviews Provide Project direction to lead, make sound team-based decisions, foster teamwork and maintain project goal-oriented focus, and drive team to meet established timelines.
- Determine and drive for stretch goals.
- Manage cross-functional team, conduct team meetings and document. Generate project progress reports and update management during scheduled project meetings.
- Document project in accordance with internal and global quality standards and establish master record files associate with development and validation activities that support global product registrations.
Cipla Ltd., Kolkata July. 2015 – Nov. 2017
- Executed and managed company-sponsored clinical trials, ensuring compliance with timelines.
- Managed and oversaw ordering, tracking, and accountability of investigational products and trial materials.
- Ensured applicable trial registration from study initiation through posting of results and support publications
- Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel Prepared clinical data review for statistical analyses and publications
- Performed monitoring activities including site qualification visits, site initiation visits, interim monitoring visits
- Contributed to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management.
- Ensured input and strong alignment from key regional Clinical R&D. Provided on-site procedural protocol compliance and data collection support to the clinical trial site.
Bayer India Ltd., New Delhi | July. 2013 – Jun. 2015
- Coordinated the R&D team employee development activities, performance reviews, and conflict resolution. Engaged with users (as required) to collect input and feedback at various stages of the development process
- Worked closely with Software Team to coordinate product scopes and schedules.
- Reviewed with marketing to translate user requirements into system and product requirements as well as maintaining an efficient R&D product roadmap. Collaborated with the Quality team to support the review of Use Risks, System Risks, and Product Risks.
- Led the mechanical and systems R&D team to maintain best manufacturing practices.
- Develop nonclinical safety plans to support clinical development and meet regulatory requirements.
- Coordinated and monitored the conduct of toxicology studies at contract research organizations (CROs) in line with project timelines and budget. Understood the basic biology of the drug candidates' intended target and mechanisms of toxicity. Formulated nonclinical safety documents including nonclinical sections of regulatory submission documents. Developed risk assessment documents for impurities (eg, extractables and leachables, degradation products, etc.). Presented data and interpretations in written and oral form to management and internal forums Built collaborative networks to facilitate cross-functional communication and activities.
- Education – Post Graduate Program in Management from Department of Social Work, Bangalore University | 2013 M.Sc. Microbiology (Microstatistics as minor) from Lovely Professional University, Phagwara, Punjab | 2011 B.Sc. Microbiology (Biochemistry as minor) from Lovely Professional University, Phagwara, Punjab | 2009
- Certification – Pharmaceutical Development Certifed Professional (PDCP) program from CfPIE | 2016
Languages Known: English, & Hindi
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