MOHAMMAD ALI RIAZ
Mokena
Summary
Director Drug Product Manufacturing and Technical Operations An Effective Hands-on Strategic CMC ( chemistry, manufacturing , controls) Leader with over 17 years of progressive scientific and people management experience in the pharmaceutical and biotech industry . Worked in different modalities and routes of administration in small molecules (OSD). Significant experience in leading and managing CROs, CDMOs , CMOs and CPOs to ensure deliverance of quality clinical and commercial products. Expertise in taking NCE from pre-clinical to commercialization. Substantial experience in regulatory submissions and ICH guidelines. Proven track record of developing BCS class II and IV low solubility NCEs.
Overview
16
16
years of professional experience
Work History
Head of Drug Product Development (Director)
Rain Oncology Inc
05.2021 - Current
- Direct reports besides external CMO, CDMO management , successfully managed Pharmaceutical department providing leadership,strategic planning and vision, and managing departmental budget
- Managed communications between clinical operation and CMC to ensure phase 2 and 3 clinical supplies were received at clinical sites in a timely manner
- Involved with API chemistry process engineering to troubleshoot issues with particle size distribution
- Successfully managed and coordinated internal and external stakeholders to ensure consistent supply of clinical material to phase 3 pivotal trials
- Authored IND, IMPD and module 3 NDA sections for Drug Product (DP), led DP strategy with FDA in
- Type C and Type B meetings with FDA
- Implemented creative solutions to mitigate risks posed by expedite NDA timeline , API supply constraint and bottlenecks at CDMOs
- Successfully led Rilzabrutunib project from Phase 1 to Primary stability batches
- Successfully completed DOE experiments to establish design space for critical unit operations
Associate Director
Sanofi US, Drug Product Development, Principia Biopharma Inc
02.2020 - 04.2021
- Collaborated with Clinical operations to lead formulation and process development of immediate and modified release dosage forms at CDMO
- Responsible for DOE design and execution including process mapping, process characterization studies, failure mode analysis (FMEA)
- Accountable for transferring in-licensed lead candidate and approve engineering, registration and validation activities for manufacturing and packaging including serialization and CPO selection
- Initiated RFPs, RFQs, due diligence of CDMO, CMO, and collaborated on selection of CPO with supply chain
- Worked on NDA filing preparation for Rilzabrutinib, executed NDA gap assessment, and authored technical reports
- Led efforts for phase 3 process development at CDMOs, validation and commercial readiness for NDA product launch preparation
- Assisted senior leadership in managing all aspects of operations
- Reason for leaving was acquisition of Principia by Sanofi Inc.
Director Commercial
Assertio, Therapeutics Inc
04.2018 - 01.2020
- Managed two direct reports of CMC personnel’s and provided oversight for CDMOs/ CMOs to ensure supply continuity of clinical and commercial supplies products from Assertio's Contract Manufacturing Organizations (CMOs)
- Coordinated due diligence activities on phase 2 molecules with parenteral route of administration using devices such as pre-filled syringes and auto injector assemblies
- Technical writing of marketing post marketing NDA supplements i.e., CBE-0 , CBE-30, and PAS
- Responsible for developing and implementing long term contract manufacturing strategies and business continuity initiatives
- Managed on-going CMC and manufacturing activities as well as led planning and execution of new programs cross-functionally
- Led strategic planning efforts for Contract Manufacturing and supply chain managing packaging initiatives such as serialization, label selection and working with CMOs artwork vendors to generate technical
- Reason for leaving: Merger and anticipation of second wave of layoffs.
Site Manager
Upsher-Smith Laboratories, Inc
01.2017 - 04.2018
- Led and managed team of 6 CMC scientists responsible for technical transfer, product development usingj) regulatory pathway
- Led qualification efforts for USP water system in response to FDA 483 observation and assigning all corrective and preventive actions cross-functionally to defend qualification efforts in front of agency
- Reviewed and approved technical documentation related to CMC such as process characterization, registration trials and validation protocolS ?reports
- Led CMC operations and supported ANDA developmental pipeline involving late-stage development and qualification Activities
- Provided strategic and direct technical support to Operations/Supply chain through entire product life cycle, providing essential technical link from R&D through clinical manufacturing, process qualification, commercial manufacturing and continuous improvement
- Mentored, coached and , trained team of junior and senior process engineers and product development scientists
- Led hiring departments for expanding MSAT department
- Reason to leave: Denver manufacturing site closure due to acquisition.
Manufacturing Manager
Horizon Pharma Inc
02.2016 - 02.2017
- Management/facilitation of manufacturing and packaging initiatives for multiple Horizon products with contract manufacturing organizations (CMO's) performing development, clinical, and commercial supply manufacturing
- Reviewed and approved change control of manufacturing documentation (master batch records, protocols/reports, specifications) in conjunction with QA
- Sourced, managed, and procured API and finished drug products, also maintained inventory of raw materials (excipient, API's, packaging supplies)
- Provided leadership in process technology transfer,implementation, and scale-up to new CMO sites and served as key Horizon technical/manufacturing contact in CMO, vendor,service provider, and internal client relations
- Participated in compliance audits of CMO's and raw material/supply
- Tracked new material shipments and coordinated flow of materials at different stages of manufacturing to align with procurement expectations
- Evaluated suppliers to maintain cost controls and improve operations
- Identified strategic business opportunities to advance technology through licensing and project development
- Reason to leave: Career advancement into Site Managerial role and reporting structure.
Senior Process Engineer
OSD, Astrazeneca, Bristol Myers Squibb
05.2013 - 01.2016
- Significant contributions to pre and post process development and manufacturing activities for marketing applications for Forxiga and Eliquis
- Supported internal, external, and regulatory filings including FDA, EMEA, and third-party inspections
- Led Six Sigma and Kaizen projects to drive operational excellence and substantial cost savings for manufacturing department
- Provided technical support for process manufacturing areas, including investigation and correction of process-related problems and deviations from standards
- Enhanced quality and effectiveness of manufacturing systems related to existing products as Product
- Subject matter expert used inter personal skills on technical projects affecting process manufacturing during internal audits and regulatory inspections
- Executed site PAT strategy to monitor and control existing manufacturing processes
- Led technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, to ITO site
- Provided pharmaceutical process support to new and existing oral solid dose form (tablet and capsule) products/processes
- Authored reviewed and approved process manufacturing master batch records Initiated process manufacturing area change proposals through Change control as required for projects managed by
- Manufacturing Technology group
- Led product scale up activities related to volume increases and/or product demand
- Increased product yield by implementing improved processes
- Created series of process optimizations to reduce production errors and increase quality
- Reason to leave: Career advancement in Managerial role.
Formulation Development Supervisor
Swiss Natural Sources
09.2007 - 09.2010
- Led Innovation projects and coordinate timely execution of product launches supervising team of scientists and technologists
- Executed trials using DOE and understanding complexities of different granulation technologies during tableting and encapsulation process Led Technology Transfer and Scale-up Operations
- Researched and compile pre-formulation data on medicinal ingredients and excipient used in product formulation
- Managed entire formulation and manufacturing department to deliver quality, safety, and productivity requirements
- Working with internal and external partners to achieve product development targets, output goals and conversion of externally produced products to in-house items
- Supervised employees and process to achieve safe, timely and accurate production of quality products.
Education
MBA - Business Administration
University of Southern Indiana
2021
Master of Science - Engineering
Heriot-Watt University
2011
Post-graduate diploma - Research
Toronto Institute of Pharmaceutical R&D
2006
Bachelor of Science - Biochemistry
University of Windsor
2005
Skills
Excellent business communication and verbal communication skills
Technical expertise in CMC and Manufacturing operations Practitioner of Innovative solutions
Work Independently and high collaboration skills Strong problem-solving skills
Great written and verbal communication skills Experience dealing with Clinical pharmacology and toxicology ,PK /PD analysis
Operations Management experience
Experience with quality system deliverables such as deviations, investigations and change control documentation
Highly accountable and data driven decision-making ability Intricately involved with Clinical Research and Operations function area
Adaptable to fast-paced and agile work environment
Seeks fast resolution of problems GMP, GLP and GDP working knowledge
Tendency to break down complex projects into manageable tasks/deliverables Project Management skills
Accomplishments
- Two approved NDA & product launches of best-in-class molecules in oncology,neurology, and orphan therapies
- Successful Product launches in both NDA and ANDA environment
- Significant contributions to phase 3 NDA modules for best in class NCE Rilzabrutinib (BTKinhibitor),
- ELIQUIS (Direct Xafactor Inhibitor), FORXIGA (SGLT2inhibitor) including FDA and global (Health
- Canada, EMA, Brazil)health authorities
- Successfully led various cross functional teams and developed NCEs from lead candidate selection and optimization all the way to commercialization
- Head of Pharmaceutical Drug Product development and a core Strategy Team Member providing technical leadership and strategic planning
- Strategic CMC expert in leading cross-functional teams working with API process engineering,
- Analytical, and drug product development
- Expertise in various dosage form development including small molecules (OSD), devices , semisolid and suspensions
- IND/NDA regulatory filing preparation and interaction with global regulatory health authorities
- Problem solving skills to overcome formulation problems with low solubility drugs to enhance bio-availability, minimize side effects, protect IP, and extend product life cycles by developing novel formulations e.g., active coating, amorphous solid suspensions
Affiliations
Member of International Society of Pharmaceutical Engineers
Member of Regulatory Affairs Professional Society
Timeline
Head of Drug Product Development (Director)
Rain Oncology Inc
05.2021 - Current
Associate Director
Sanofi US, Drug Product Development, Principia Biopharma Inc
02.2020 - 04.2021
Director Commercial
Assertio, Therapeutics Inc
04.2018 - 01.2020
Site Manager
Upsher-Smith Laboratories, Inc
01.2017 - 04.2018
Manufacturing Manager
Horizon Pharma Inc
02.2016 - 02.2017
Senior Process Engineer
OSD, Astrazeneca, Bristol Myers Squibb
05.2013 - 01.2016
Formulation Development Supervisor
Swiss Natural Sources
09.2007 - 09.2010
MBA - Business Administration
University of Southern Indiana
Master of Science - Engineering
Heriot-Watt University
Post-graduate diploma - Research
Toronto Institute of Pharmaceutical R&D
Bachelor of Science - Biochemistry
University of Windsor