Project Manager Portfolio Management
Resume:
Current Job Responsibilities (MSD Animal Health (through Kelly services), September 2023 to present) Professional summary
Core Competencies
Sumalatha S, PhD, PMP®
Associate Director, API Tech and Portfolio management, Global team Email: ************@*****.*** Contact: +91-879******* PMP certified Project Manager holding a PhD degree in Organic Chemistry, having excellent communication and interpersonal skills, technical expertise in small molecule synthesis and demonstrated experience in leading project/portfolio management. A valuable contributor and consistent quality performer with proven expertise in strategic planning, execution, decision- making and leadership.
Assertive, result-oriented professional with about 22 years of diverse experience in Drug Discovery Chemistry Research and Key account/Delivery Management of global API supply partners.
Demonstrated track record in delivering consistent excellence in performance through effective communication, team supervision, coordination, planning and execution.
Excellent interpersonal communication skills and extensive experience in establishing stretch goals and driving projects to successful completion within stipulated timelines.
Proven ability to maintain strong working relationships with technical, quality and operations leaders.
Hands-on experience and subject-matter expertise in process/medicinal chemistry having sound knowledge in regulatory, quality and analytical domains and well versed with the ICH and other regulatory guidelines.
Highest integrity, honesty and transparency in dealing with all situations; adept in building excellent working relationships and motivate teams in achieving set annual business objectives.
Adaptive to change and focused on continuous learning and application of acquired knowledge to achieve personal and organizational excellence.
Strong leadership attributes and strategic business acumen.
Primary point of contact for a Supplier Portfolio of 8 generic products, responsible for fostering stakeholder collaboration by leading external and internal Tier meetings for Portfolio management.
Performing due diligence audits for supplier selection as technical co-lead, identifying gaps by review of Process Validation Protocols, Master and Executed Batch Manufacturing Records, Approved Vendors List, Validation Reports and ensuring compliance with the filed CMC information.
Verifying the aspects of supplier selection by appropriate consideration including assurance of supply, quality, service, affordable cost and innovation.
Interface with the External Manufacturing & Global Procurement team at MAH to develop and manage the supply base and complete sourcing projects. Page 2 of 5
Job Responsibilities at Laurus Labs Limited (April 2017 – August 2023)
Evaluate new suppliers for different business cases by reviewing the proposals, route of synthesis for GMP manufacture of APIs wrt key starting materials, regulatory compliance and cost effectiveness.
Participate in hypercare programs post action indicated audits, CAPA follow-ups and review the remediation plans related to culture development or CAPEX involvement.
As a member of Sustainability Task Force, responsible for Process Mass Intensity (PMI) and Life Cycle Assessment (LCA) calculations of the API processes and establish comparison of baseline, validated and cost optimization processes.
Align internal and external stakeholders on Change Proposals to assess quality and regulatory implications.
Organizing cross-functional meetings for strategizing DMF (CEPs and VMFs) filing across various regulatory markets and switch plans to introduce new API suppliers to ensure sustained material supply to the DP sites as support to the procurement team.
Coordinate for evaluating the Selection of Regulatory Starting Materials and Fixing of Regulatory Specifications across global markets.
Coordinate assessment of Regulatory Queries and their timely and adequate responses by the suppliers.
Participate in strategic Tier meetings to trouble shoot technical and quality issues such as equipment suitability, solvents/materials recycling, identification of critical process parameters and materials attributes, quality failures and cGMP non-compliance by suppliers.
Generate technical packages, involve in the material physical property and chemical comparability assessments such as PSD modality, polymorphism and solubility to ensure formulation viability.
Primary point of contact to Merck Focus Factory team, responsible for commercial deliveries of three custom generic products to MSD Human Health by coordination between internal PPIC, production, quality and regulatory teams to ensure uninterrupted product supply.
Key account manager for managing nine ophthalmic portfolio CDMO products for an Irish company; responsible for lifecycle management of the products in different stages of execution.
Developed project plans, project cost and timeline estimates in consultation with stakeholders and monitored projects’ health at stop-gate checks and key milestones.
Was responsible for supply of several APIs in compliance with safety, quality and regulatory standards and as per the delivery schedules.
Organized and lead cross-functional project meetings and drove all project activities including trouble shooting and brain-storming risk mitigation strategies.
Appraised teams on project scope, deliverables, resource allocation, and anticipated challenges.
Analyzed products forecast and coordinated with PPIC team for timely procurement and management of materials, allocating resources and manufacturing slots for batch execution.
Ensured multiple projects are seamlessly executed through proper resource allocation and planning; prioritizing projects considering timelines, associated risks and business impacts.
Monitored/maintained project schedules through micro-level forecasts/Gantt charts using MS Project.
Organized and lead cross-functional meetings for strategizing DMF filing, Selection of Regulatory Starting Materials, Fixing of Specifications and addressing Regulatory queries.
Lead Technology Transfer Projects from organizing kick off meetings till completion of product manufacture and transfer to owner site.
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Job Responsibilities as R&D Scientist in GVK Bio (June 2002 to Mar 2016)
Organized desktop audits for the evaluation of Contract Manufacturing Units and ensure Audit Reports and Compliance Reports are in place during Covid-19 pandemic.
Was responsible for archival of all project documents like campaign updates, closure reports, assessment reports etc. and prepared Project Summary Reports as part of lessons learned.
Reviewed and coordinated in finalizing all regulatory documents and reports such as Manufacturing Process Development Reports, Technology Transfer Documents, Specifications, Test Procedures, Validation Protocols and Reports of lifecycle APIs to meet Pharmacopoeial/ICH/Regulatory requirements.
Reviewed production and quality related change controls and timely appraised all the internal stake- holders and customer on the regulatory impact of related changes.
Strong-hold in assessment and identification of DMF gaps, assessment and control of mutagenic impurities, carryover studies and anticipated regulatory deficiencies.
Organized and spear-headed periodic meetings with internal stakeholders for monitoring the project’s progress as well as tech transfer meetings among different locations.
Lead Tier meetings with external stakeholders to provide timely, transparent and comprehensive project updates and reports.
Coordinated with internal stakeholders to obtain licensure documents such as Export/import licenses, test license, manufacturing license and export related certificates like CoPP, FSC, EU Written confirmations.
Liaised with third party service providers for notarization, attestation, apostillization and legalization procedures at public notaries, MEA and embassies of different countries.
Assigned Key Result Areas to team members and periodically guided them in achieving the company objectives.
Monitored and tracked timelines for key milestones on weekly basis and on-time escalation of delays/issues to senior level management for quick resolution.
Maintained open communication across functions and geographies to track shipments and facilitate on-time delivery.
Worked as scientific manager in drug discovery for generating series of leads for anti-obesity targets; coordinated with biology team for in vitro and in vivo studies of the leads in clinical trials.
Designed and synthesized various heterocyclic compounds, accomplished Hit to Lead and Lead optimization projects.
Discovered new synthetic routes/reagents to synthesize target molecules and optimized conditions to cut down the project costs.
Was responsible for QSAR analysis of the synthesized molecules for preparing library of new compounds.
Executed projects from start to finish that included procuring raw materials, executing lab work, evaluating spectroscopic data by NMR, MS and shipping out the target compounds.
Prepared proposals and project cost estimations for new targets assigned by the clients.
Assigned activities to team members, supervised to ensure all project requirements specified by the customers are met.
Conducted safety audits, lab notebook audits and maintained chemical inventories.
Was responsible for target identification and target validation for high throughput screening, synthesized hits obtained from HTS for the validation of results.
Prepared project updates and periodic reports, participated in client meetings and technical communications internally and with global partners. Page 4 of 5
Publications
Technical Competencies
Educational Qualification and Certifications
Microsoft office, MS Project, 4Minitz, Reaxys, Citrix ELN, Scifinder, Chemdraw & ISIS draw.
Expertise in ACS PMI tool for calculating and comparing Process Mass intensity for APIs.
Hands on experience on Reliance Change control process (initiator and manager) and knowledge on Alexx submission portal for regulatory document review and submission.
Knowledge of Mirabilis in performing the purge factor calculations and establishing control strategies for potentially mutagenic impurities in APIs.
PhD in Organic chemistry from JNTU Hyderabad
PMP certification from PMI (PMP number: 2178794)
Post graduate diploma in Pharma Regulatory affairs from IGMPI (Recognized by govt. of India)
MSc in Medicinal Chemistry from Osmania University, Hyderabad
BSc in (Chemistry, Microbiology, Zoology) from Osmania University, Hyderabad
Sep 2023-present: Associate Director, MSD Animal health (through Kelly services)
Mar 2017-Aug 2023: Senior Manager-Project Management, Laurus Labs Ltd.
Jun 2002– Mar 2016: Associate Scientist at GVK Biosciences (Now Aragen Lifesciences)
“Synthesis and anti-inflammatory activity of 1,2-3-substituted 2a1,4,5-triazacyclopenta[cd]indene derivatives” Sumalatha Sanivarapu, Lakshmi Velide, Namratha Vaddiraju, Medicinal Chemistry research 2019, Volume 28, Pg 1461–1470
“Synthesis and Biological Evaluation of Different 1,2,4-Triazolearyl Incorporated Thiazolepyridine Derivatives as Anticancer agents” Sumalatha Sanivarapu, V Namratha, Lakshmi Velide, Russian Journal of General chemistry 2020, Vol. 90, No. 12, pp. 2381–2385
“Synthesis and biological evaluation of chalcone derivatives of acridines as anticancer agents” Sumalatha Sanivarapu, Namratha Vaddiraju, Lakshmi Marepally, International Research Journal of Pharmacy, 2019, Volume 10, Issue 10, Pg 93-98
Conference paper, “Synthesis and biological evaluation of Isoniazid derivatives as potential Anti- tuberculosis agents” Sumalatha Sanivarapu, Lakshmi Velide, Namratha Vaddiraju, International Journal of Advance Research in Science and Engineering 2019, Vol 8, Issue 12, Pg 13-21; International Conference & Academic Excellence Award on Recent Innovation and Interdisciplinary Research, Dec 2019, Mumbai.
Employments/Designations
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Key Achievements
Established database for PMI/LCA calculations and in turn Kg CO2, Kg material and Kg solvent savings for baseline of 10 APIs and 6 validated processes via ACS PMI calculation tool.
Received appreciation by an MNC client for liaising and leading cross functional teams to successful plant validation within record time and successful regulatory filing for high regulated markets through meticulous planning.
Achieved business continuity and operational efficiency with risk mitigation strategies by harmonizing the material procurement and inventory maintenance processes.
Built sustainable trust of an MNC client with large portfolio through transparent and timely communication that resulted in resolution of all pending issues and the client giving more business.
Built a system for effective follow-ups and track all project management activities; set-up a mapped Project Document Management drive for easy and controlled access to all project related documents thereby eliminating redundant transfers of exiting documents.
Received monetary reward and appreciation for ensuring seamless execution of some commercially important projects during Covid-19 pandemic through effective co-ordination among multiple stakeholders from different manufacturing units.
Standardized Unit Price of several commercially important products by identifying the discrepancies between POs and contracts thereby making significant cut backs in budgeting.
Received appreciation for achieving OTIF >85% by constant coordination and alignment with supply chain, manufacturing, quality and logistics teams for commercial deliveries.
Generated therapeutically active leads in short time within the scope of therapeutic targets.
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