Skills
Summary
Work History
Carrier Objective
Technical Profile
Academic Qualification
Disclaimer
Overview
Manager
Kamesh Yerramilli

Kamesh Yerramilli

Hyderabad

Skills

  • Skilled in MS Office tools like MS Word and MS Powerpoint & MS Excel (filters, formulas, pivot tables, charting)
  • Good command of PMO and SPOC
  • LMS, LIMS, SAP for billing, pass-through cost
  • Agile methodologies, SDLC and software methodologies, JIRA
  • Management knowledge
  • Financial management
  • Planning & organizing
  • Business planning
  • Progress reports
  • Risk management
  • Procedure Implementation

Summary

Having 11 years work experience in project management. Specialist in trouble shooting, planning and execution of project, resource management, budgeting costing analysis, conflict management. Worked for Microbiology, Biology, Formulations & Analytical departments in GMP environment and USFDA approved laboratories. Rich with quality experience with technical and management system. Well versed with project deliverable tools like LIMS, SAP, LMS. Familiar with JIRA, Agile & SDLC methodologies.

Work History

Manager

Aragen Lifesciences Pvt Ltd
Hyderabad
06.2019 - Current
  • Identified project scopes, timelines and budget for the contract development
  • Identify and communicate project deliverables to all stakeholders
  • Tracked project performance to analyze successful completion of short- and long-term goals
  • Engaging internal and external clients to develop logistics concepts and solutions in order to meet study deliverables, objectives and profitability while achieving client satisfaction
  • Ensure study/project timelines and budgets are met in accordance to the contractual agreement including proactive management and communication of timeline changes to ensure the efficiencies are maximized
  • Ensure that study specific management tools and documents are in place and constantly maintained
  • Perform risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly Prepare, participate in and follow up on audits/inspections
  • Undertake the full range of project-based duties relevant to the leadership, management, and development of the project team to ensure their performance meets and/or exceeds the requirements to be fulfilled both on the study as well as on a personal goals/objectives level
  • Develop & manage execution of project or program related clinical supply, sourcing, manufacturing, distribution & laboratory logistics strategy with relevant stakeholders in line with applicable regulations
  • Communicate with third party providers and negotiates scope of work in conjunction with procurement
  • Utilize applicable tools for supply chain simulation and forecasting
  • Develop, plan and manage inventory according to strategy, quantities and forecast
  • Develop supply schedule, seeks feedback from Clinical team on study progress and adjust accordingly and provide feedback to depots
  • Develop and implement production, depot and distribution strategy including collaborating with 3rd party depots with relevant stakeholders
  • Overview the operational management of programs and assets
  • Ensures study/project timelines and budgets are met in accordance with the contract agreement
  • Finance and Profitability Management (Monthly, control, input) incl
  • Client invoicing
  • Maintain Parexel’s Internal Project controlling/Financial systems including but not limited to monthly revenue and forecasting
  • Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers incl
  • Invoicing
  • Monitors the projects status and identify for any potential Change in Scope (CIS) needed in a timely manner
  • Gather feedback and evaluate on the projects status and identify for any potential CIS (Change in Scope) for professional services and/or PTC needed in a timely manner to ensure that the operational tasks are contractually covered
  • Follow through on any CIS until signature
  • Contributes to profitability/finance management (monthly reporting & forecasting, budget control, change in scope management)
  • Act as main point of contact for internal and external customers and use a consultative approach in issue resolution
  • Proactively engage with external and internal clients in solution improvements
  • Work towards establishing positive relationships with internal and external clients
  • If required actively take part in the bidding process (Proposal, 3rd Party Vendor Selection, Bid Defense, contracts negotiation and review) including client presentations
  • Represent Parexel at professional meetings/conferences as participant and/or speaker
  • Assist in managing increased demands and expectations of customers through consistency and predictability in internal procedures and avoidance of crisis situations
  • Lead project meetings and support team members to monitor and ensure that projects is completed within budget, schedule and according to contract specifications in accordance to the quality standards, SOPs, ICH-GCP, GMP, GxP and/or any other guidelines to fulfil local regulations, including customs regulations
  • Implement process improvements, including CAPA, in conjunction with the team, in response to corporate, quality issues, client and team feedback and quality audits
  • Performs risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly
  • Ensure that study specific management tools and central file maintenance plan are in place
  • Ensure project related training are properly assigned to project team members and their timely completion.

Sr. Executive Project Management

Wockhardt Bio AG
Dubai
03.2016 - 06.2019
  • Develops project plans for all aspects of assigned projects and manages all project activities
  • Establishes and leads cross functional project teams and status meetings
  • Obtains consensus and buy-in from key internal and external stakeholders for project timeline
  • Monitors and manages project scope, budget, forecast, resources, and deliverables within timeline
  • Maintains up-to-the-minute project action plans and serves as a resource to stakeholders
  • Develops and mentors project team members
  • Provides timely, comprehensive project status reports, including budgets and timelines
  • Ensures all stakeholders receive the required level of detail commensurate with their role
  • Provides input on strategic goal, tactical planning, and high-level staffing plans.

Senior Executive

AUROBINDO PHARMA LTD
Hyderabad
08.2013 - 03.2016
  • Activities like Initiation of PNC’s, change controls, exceptions etc., worked with various cephalosporin’s products
  • Tested Microbial Limit Test, sterility samples, endotoxin samples, gram stain in support of aseptic processing as well as raw material and final product release
  • Participated in validation activities for compendial microbial methods as well as media fills
  • Managed test samples according to standard operating procedures (SOPs) & Maintained equipment, reagents and laboratory
  • Responsible for preparation and revision of SOPs, test methods, batch records, and other controlled documents
  • Support the development of LIMS and a member of the Project Execution Team for the Microbiology department
  • Having good exposure in QMS related & Maintain compliance with occupational safety and health, especially regarding hazardous materials/waste
  • Training coordinator for the monthly Refreshment Training & Adhered to good documentation practices to ensure data integrity and traceability.

Trainee Officer

Natco Pharma Ltd
Chennai
06.2012 - 08.2013
  • Helped conduct the setup of a new Microbiology Laboratory in the company by writing SOP’s, ordering equipment, contacting various vendors and manufacturers, etc
  • The following are the duties performed upon completion of the Microbiology Laboratory setup and approval
  • Responsible for Media preparation and GPT, Microbial Identification & Performed Water analysis and Sampling
  • Experienced in using bright field light microscope to view and interpret slides.

Carrier Objective

To pursue a challenging career and be a part of progressive organization that gives a scope to enhance my knowledge and utilize my skills towards the growth of the organization by committed and high quality work.

Technical Profile

Java

Academic Qualification

M. Sc. in Microbiology

Disclaimer

I hereby declare that the above-written particulars are true to the best of my knowledge and belief.

Overview

12
12
years of professional experience
Kamesh Yerramilli