Nomaan Mohammed

Plainfield, IL

adwzwt@r.postjobfree.com +1-773-***-****

CAREER HIGHLIGHTS

CMC Portfolio Project manager with over 15 years of experience in development and post-commercialized product development & life cycle management. Well-versed with the R&D program management life cycle approach, entity acquisition, program internalization, PH3 to commercial handoff, and CMC regulatory submissions. A self-motivated and dynamic leader with the capability to effectively collaborate with diverse cross-functional teams and external stakeholders including Product Leads, Regulatory, Quality, Supply chain & CMO operations teams on R&D functions.

KEY COMPETENCIES

Program Management Clinical Development Regulatory CMC/ Manufacturing CMO oversight Risk Register IND/IMPD/CTA Communication Plan Content Plan Budget Management Vendor Management Supply chain management Negotiation Skills Project Management Presentation Skills Communication Skills Relationship Management Stakeholder Management Risk Management

Prioritization Skills, Analytical Support, Analytical Skills, Dynamic Environment, Flexibility, Teamwork, Motivated, Fast-Paced, Passion, Passionate, Judgement, Influence, Written Communication, Verbal Communication, Collaborator, Collaborative Quantitative, retail, Presentation Skills, strong analytical skills, customer experience, data Presentation, internal Stakeholders, Flex, Ideal, Station, Business Management, management skills, Troubleshooting, Writing, Mobile, Mobile App, Mobile Marketing

WORK EXPERIENCE

AbbVie Inc North Chicago, IL

Product & Portfolio CMC Lead May 2021-Present

Translated and simplified CMC leadership team strategy into an efficiently executable plan in collaboration with the core SME team including Analytical, Quality, Regulatory, Supply, and program leaders.

Contributed to innovative program internalization/externalization/ process transfer/tech transfer and managing high-risk CMO from CMC risk and process improvements perspective.

Well-versed with strategic CMC regulatory pathways, agency communication, content plan, kick-off meeting, IND changes, Supplier practices, CMO oversights, and supply chain oversight.

Drafted CMC strategy project charter, program risk register, communication plan, content plan, kick-off meetings agenda, routine meetings notes, and action item trackers.

Interfaced with management and influenced decision-making, managed and mitigated development risks, and ensured risks are escalated, communicated, and mitigated as needed.

Worked cross-collaboratively between Program Leader, Project Managers, and CMC leads to ensure the scientific and commercial strategies were incorporated into the CMC strategy and integrated development plan

Assisted in producing portfolio-level reports in collaboration with more senior leadership and project manager including the core CMC team to have strong process/program oversight.

Responsible for the development and management of the Allscripts content development and

training team within Prospect Medical Holdings.

Collaborated with cross-functional teams, including research and development, marketing, sales, finance, and legal teams

Responsible for identifying and mitigating risks associated with the portfolio which included assessing potential regulatory and legal risks, as well as evaluating the potential impact of changes in the market or competitive landscape.

Capgemini (Multiple clients) Chicago, IL

CMC Portfolio Program Manager Jan 2017-Apr 2021

Managed various CMC scenarios, submission planning, procurement, CMO operations, and risk assessment and mitigation plans for assigned development programs to meet the timelines.

Executed responsibilities of CMC portfolio lead to support regulatory filings, CMO process tech transfer, clinical trial material shipment support, and change assessment & Implementation.

Actively contributes to and manages staff to develop and implement global regulatory CMC strategies including clinical trial applications, marketing applications, and life cycle management.

Review/Approve technical documents such as Master batch records, batch release records/manufacturing reports (upstream & downstream processing), process-related deviations, change control, QC protocols, and reports.

Responsible for overseeing the development of new pharmaceutical products, from the initial discovery stage to FDA approval working closely with research and development teams to identify promising compounds and ensuring that development timelines and budgets are met.

Assisted CMC Regulatory Lead in the preparation of stage gate minimum requirements documents to ensure minimum questions from agencies during IND/IMPD submissions.

Well-versed with regulatory pathways and tools such as FDA meeting requests, Briefing documents, IND amendments, risk registers, communication plans, and content plans.

Presented CMO activities to leadership ensuring timeline expectations are reflected in project activities based on allocated budget and team capabilities.

Amita Health Inc Arlington Heights, IL

Project Manager Program/ Regulatory/CMC compliance Dec 2014-Nov 2016

Executed duties of CMC project manager for overall Regulatory submission readiness, CMC development activities, and CMC program strategy.

Assisted project manager in drafting the content plan, project charter, risk register, escalation charter, communication plan, and CMC core team SharePoint site.

Work cross-functionally on Program Teams with Analytical, Process lead, non-clinical, clinical development, clinical operations, regulatory, and translational to advance program goals.

Supported CMC sub-teams (external manufacturing, supply chain, analytical testing, apheresis operations) to ensure CMC activities are aligned with program goals and timelines.

Escalated program risks such as CMO operations issue, compliance GAP, Audit, complaints, product design failures, OOS, delay in product release, and data migration gaps to leadership.

Worked with finance, HR, supplier QA, and legal to ensure MSA, SOW, and QTA are set up accurately for vendors and routine non-routine service providers.

Supported program internalization, entity acquisition, integration, product compliance, data migration, ERP system integration, and process /tech transfer for assigned programs.

Maintained Project timelines by managing the orders from the point of order to post Purchase Order tracking and shipping follow-up. Oversee technical releases of rare custom synthesis materials, compliance, and global shipping documentation review and approval.

Al Doaa Doha, Qatar

Project Manager June 2010-Sep 2014

Managed multiple large-scale, cross-functional project rollouts for 200 clinics in the MENA region from initiation to close.

Lead, understand, develop, and deploy the business’ vision for the Field Medical Planning Tool (FMPT).

Managed the end-to-end project from initiation, planning, budgeting & forecasting till deployment.

Managed the cutover process to ensure the successful deployment of project components from pre-production environments.

Managed the project intake, work management, and product’s end-to-end lifecycle using Smartsheet.

Accountable for end-to-end management of a project including all standard project management processes and deliverables such as the cost/budget, schedule and dependencies, resources, scope, RAID, change management, release management, and communications.

Prepared project timelines, milestones, dependencies, and estimated completion dates based on the scope.

Managed projects from their assignment and conception to their implementation, documenting their deadlines, and preparing status reports to inform the project teams and their leaders.

Developed feasibility and Project risk analysis to ensure requirements can be met.

Regularly monitor utilization of released functionality, looking for trends, and share utilization data and trends with Product Managers to identify areas of opportunity and recommend ideas.

Hetero Labs Hyderabad, India

Research Analyst July 2007-May 2010

Gathered data from a variety of sources and compile the information into an easier-to-review form.

Reviewed information and data to determine specific issues, strengths, and areas of improvement.

Drafted reports about the findings.

Participated in teams designed to improve the quality of care and processes.

Developed potential strategies that could help others improve the health field by giving them the data needed to make educated decisions about the future of medicine, health care, and public health.

Looked at the overall effectiveness of medications that are being tested or brought to market.

Identified trends and gathered industry insights that included competitive intelligence.

Worked closely in conjunction with other teams to develop strategies for using data to gain a competitive advantage, and improve operation.

EDUCATION

B.E in Computer Science from Barkatullah University, India

MS in Information Systems from the University of the Cumberlands, KY

CERTIFICATION

Certified Six Sigma Green Belt

Credential ID: BEDU # 11789

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