Sajid Mohammed
Summary
Seeking position as a Head-R&D Formulation/Manager in your great organization.
- Over 20+ years of executive management experience in pharmaceutical R&D.
- Strong background in Formulation Development, Process Validation, Technology Transfer (In-house & Third party), QA, Clinical studies, Regulatory Affairs / intelligence and mfg. of IND/NDA/Generics, biologicals & vaccines.
- Demonstrated ability to balance the acceleration of FTF (first to file) & QDIbD (Quality data integration based design) implementation.
- Proven skills in Cost effective product development of various dosage forms, budget Proposals and Investments.
- Key strategic acumen in paradigm In-Licensing projects management & Out-Sourcing (externalization & virtualization) business development.
- Pharmaceutical Graduate of M.Pharm., Ph.D. (Pharmaceutics) & MBA (Project Management).
- Software skills include: - DOE, SAP, ERP, QMS, TRACKWISE, VEEVA VAULT, DOCUSIGN program.
Overview
26
26
years of professional experience
Work History
Manager (Head) - R&D, Formulation Development, Technology Transfer, Development QA
Raised Pharma
06.2024 - Current
- Leading Scientific teams, assigning job responsibilities, managing resources, review deliverables, performance & provides high-quality scientific advices.
- Providing scientific leadership & technical direction for product development projects and leading groups scientific personnel.
- Supervised/involved execution of pre-clinical, Clinical, Registration & Commercial batches.
- Leading registration submission towards NDA and ANDA/Generics regulatory applications including variation submission post marketing authorization.
- Leading Formulation designing & development by QBD for IND/NDA/Generics.
- Critical appraisal of material related to the preparation of draft answers to questions posed by the manufacturer regarding drug development plans.
- Manage & optimize R& D budget, ensuring cost efficiency & timely delivery of projects.
- Conducting internal reviews of reports (e.g., formulary reviews, excipient selection, therapeutic reviews, and health technology assessments); ensuring compliance with all established internal processes, methodologies, and quality standards.
Manager - R&D, Formulation Development, Technology Transfer, Development QA
Thermofisher Scientific
01.2019 - 05.2024
- Company Overview: Ohio, USA/Canada
- Leading Scientific teams, assigning job responsibilities, managing resources, review deliverables, performance & provides high-quality scientific advices.
- Providing scientific leadership & technical direction for product development projects and leading groups of total 20+ scientific personnel.
- Supervised/involved execution of pre-clinical, Clinical, Registration & Commercial batches.
- Leading registration submission towards IND, NDA and ANDA/Generics regulatory applications including variation submission post marketing authorization.
- Leading Formulation designing & development by QBD for IND/NDA/Generics.
- Critical appraisal of material related to the preparation of draft answers to questions posed by the manufacturer regarding drug development plans.
- Manage & optimize R& D budget, ensuring cost efficiency & timely delivery of projects.
- Conducting internal reviews of reports (e.g., formulary reviews, excipient selection, therapeutic reviews, and health technology assessments); ensuring compliance with all established internal processes, methodologies, and quality standards.
- Reviewed pre-formulation data, IP. data and excipients used in the formulation project.
- Leading designed and evaluate formulation trials to develop, optimized formulas & Process.
- Experience/review biosimilar products development & process development.
- Supervising /review optimized excipients quantities, Process optimization, feasibility & troubleshooting for commercial batches at production floor.
- Managing internal & external meetings, outsources development, CRO, CMO, new material suppliers, and tools available to the industry for product development.
- Reviewing Formulation development report in support of regulatory dept.
- Supervising pre formulation to stability studies & implementing guidelines of HC, FDA, EU, SFDA, GCC & ICH.
- Provided advice to research staff on methods including protocol development, data analysis, statistical analysis, and guidance in the interpretation of statistical analyses.
- Developing and delivering technical education and training for internal research staff and external clients, including supervision of University students.
- Developing and delivering key strategic initiative papers related to scientific and technical methods, processes, etc., including 'white paper' briefs that are the foundation of future Thermofisher Scientific activities with stakeholders and partners in USA and internationally.
- Prepared Thermofisher Scientific methodology reports and peer-reviewed manuscripts, as required.
- Experienced & Knowledge of analytical methods such as PXRD, TGA, DSC, HPLC, GC, NMR, FTIR & UV Spectroscopy.
- Review, author, compile CMC section & assisted for final submission to USFA, HC, EU, SFDA.
- Broad knowledge and experience in research methods used in clinical trial design methods, quality assessment of clinical trials, clinical systematic reviews, network meta-analyses.
- Extensive knowledge of key methodological guidance reports and guidelines related to the conduct of clinical trials, and the ability to apply that knowledge to the critical appraisal of individual clinical trials.
- Liaised with project management, analytical development (ARD), toxicology team, CMC regulatory team, QA/QC & production dept.
- Liaised with experts and representatives of academia and external organizations or agencies (local, provincial, and national) to promote and align Thermofisher Scientific methods, processes, approaches, and tools with current best practices to ensure scientific credibility and continuous quality improvement, and to reduce duplication.
- Ohio, USA/Canada
- Participating in high-level scientific advice meetings with pharmaceutical manufacturers and clinical and academic experts; attending Pan-Canadian Oncology Drug Review Expert Review Committee (pERC) and Canadian drug expert Committee(CDEC) meetings.
- Keeping abreast of current issues in the Canada's Drug agency (CDA) and pERC.
- Staying current on new developments in clinical trial design and analysis relevant to the Scientific Advice Program, and maintaining an awareness of drug pipelines and early drug development activities of pharmaceutical manufacturers.
- Exceptional analytical and problem-solving skills, with the ability to independently problem-solve and determine the best course of action using research, logic, and evaluative judgment.
- Experience in the peer review process used for scientific reports and consulting with clinical and academic experts.
- A demonstrated ability to guide staff in their development of protocols, application of research methods, and in the writing of R&D report.
- Knowledge of, and experience in, pharmacoeconomic.
Manager - R&D and Regulatory File Preparation
Advanced Orthomolecular Research
10.2017 - 11.2018
- Company Overview: Alberta, Canada
- Reviewed, authored, compiled CMC section & assisted for final submission to USFA, HC, EU.
- Led registration submission towards IND, ANDA and 505b (2) regulatory applications including variation submission post marketing authorization.
- Responsible for overall formulation development and clinical supplies manufacture for Sterile & Non-sterile products (solid, liquid, semi-solid, nutraceutical products) and registration.
- Provided scientific leadership & technical direction for product development projects and led multiple module groups scientific personnel.
- Responsible for, the execution and delivery of studies (e.g. Technology transfer, Clinical Planning, Regulatory Affairs, Global Drug Safety, Pharmaceutical R&D, R&D Quality Assurance).
- Evaluated scientific data to design experiments, maintain quality standards as per regulations.
- Led Trails design based on QBD, QTPP, Critical Quality attributes, Critical Process Parameters.
- Solved technical issues & guide to team members.
- Trained, developed RND team members for products development, process optimization & Process validation Protocol (PVP), (PVD), (PVR).
- Led pre formulation to stability studies & implemented for Health Canada & US FDA.
- Reviewed/Advised Master batch records (MBR), PBR & selection of excipients.
- Evaluated C of A for qualification of new & existed vendors for RM.
- Reviewed, prepared, compilation CMC sections & experimental results & shared with RA dept.
- Liaised with project management, analytical development (ARD), RA, QA/QC & production dept.
- Presentation of the project to group and interdepartmental.
- Provided technical support to Technology transfer, process validation and commercial production.
- Processed of Change Controls, Deviations and CAPAs.
- Worked as an internal technical consultant and provides support to projects & QA dept.
- Investigated complex issues & troubleshooting of commercial batches on floor.
- Alberta, Canada
- Trained a formulation team for drug products development, process development, optimization of process.
- Set up formulation department.
- Reviewed & advised for protocols, MBRs, PBRs.
- Dossier submission of numerous ANDAs projects to HC, USFDA, EU market.
- Developed and commercialized several products: Drug products & nutraceutical products.
Supervisor - R&D Formulation Development & Regulatory File Preparation
Riyadh Pharma
08.2015 - 08.2017
- Company Overview: Riyadh, Saudi Arabia
- Trained a team member to work in a group for drug products development, process development.
- Literature, Patent search, Designed & developed new formulation strategy to meet target timelines.
- Developed stability protocols & implemented.
- Evaluation of Formulation development, process optimization & Scale-up for Solid orals (IR &MR), liquid orals, topical semisolids dosage forms.
- Supervised pre formulation and compatibility studies, excipients selection, vendor selection for API & formulation equipment's selection.
- Project Management, Materials Management, Equipment Schedulers, Analytical Development, toxicology team, CMC regulatory team and other functional areas to meet project and team objectives.
- Reviewed, authored, compiled CMC section & assisted to Regulatory Team to SFDA.
- Riyadh, Saudi Arabia
- Setup new equipment's in formulation lab & developed various solid oral, semisolid & liquid dosage forms.
- Reviewed/assisted dossier submission of numerous ANDAs projects.
Supervisor - R&D Formulation Development & Regulatory File Preparation
HIKMA
05.2014 - 06.2015
- Company Overview: Riyadh, Saudi Arabia
- Led a team of scientist & mentoring juniors.
- Literature & Patent search, Pre formulation studies, Formulation Development, optimization, brand extensions for oral solid, liquid & semisolid dosage forms.
- Supervised for sterile & non sterile product/ process development & technology transfer.
- Detailed survey of new drug application (NDA) & abbreviated new drug application (ANDA) as per guidelines.
- Reviewed /Supervised execution lab scale to commercial batches, pre formulation and compatibility studies, excipients selection, vendor selection for API & formulation equipment's selection.
- Reviewed, authored, compiled CMC section & assisted to Regulatory Team to SFDA, USFDA.
- Riyadh, Saudi Arabia
Sr. Formulation Research Scientist - R&D
Taro Pharmaceuticals
07.2008 - 05.2010
- Company Overview: Toronto, Canada
- Led a team of scientist & Intern's.
- Literature & Patent search, Pre formulation studies, Formulation Development, optimization, brand extensions.
- Detailed survey of new drug application (NDA) & abbreviated new drug application (ANDA) as per guidelines for solid oral & liquids, topical semisolid dosage form and tracked and carried-out Competitor Product and profile studies.
- Scaled-up formulations (Planning & Executing) from bench to Pilot Scale, Pilot to main Plant levels and monitored the stability performance while maintaining the global stability protocol.
- Comparative studied of test & reference products.
- Developed sterile & non sterile dosage forms includes modified release oral formulations such as enteric-coated, SR & immediate release tablets.
- Reviewed /Supervised for small-scale batches for semi-solids, liquids, compressed, enteric coated and film coated tablets, capsules, and powders as per approved project plan and protocol.
- Solved in-process problems, during experimental trials and production batches for granulation loss of dryness, powder flow, capping, chipping, sticking, picking, blending, mottling, Viscosity, spreadibility, pH, density physical stability studies, in-vitro diffusion studies.
- Examined in-process quality testings on trials and production batches for Viscosity, pH, spreadibility, extrudability, physical stability studies, in-vitro diffusion studies, weight, hardness, thickness, friability, disintegration, dissolution test and leak test.
- Supervised for requisition & maintain of API, excipients for experimental trials.
- Prepared master formula record or protocols.
- Toronto, Canada
- Developed & dossier submission of numerous ANDAs projects of various dosage forms.
- Developed and commercialized products: Tacrolimus ointment, Mometazone cream, Testosterone gel, Clindamycin phosphate gel, Minoxidil topical lotion, clotrimazole topical lotion, Sildenafil citrate tab FC, Montelukast tablets FC, chewable tab and Granules.
Dy, Manager -Formulation (R&D)
Falma Laboratories
06.2005 - 05.2008
- Company Overview: India
- Led a team of formulation scientist team & analytical team.
- Reviewed/assisted dossier preparation & submission for ANDAs application.
- Responsible for providing expert advices in formulation design, process optimization and cGMP compliance for drug substances and various oral solid/ semisolid products developed to fulfill US standards. Supported planning and execution of technical or regulatory due diligences to ensure better strategy and regulatory pathway.
- Specialized in generation, maintenance & revision of documentation systems for SOPs, specifications, batch records, OOS / OOT investigations, training, process and cleaning validation records.
- Reviewed manufacture records & analytical testing of raw materials and finished products. Directed troubleshooting in manufacturing and packaging deviations.
- Managed technical alliances with off-site contract laboratories or universities. Directed contact and interaction with partners, clients and CRO/CMO.
- India
- Formulation development & dossier submission of numerous ANDAs projects of various dosage forms.
- Developed and commercialized several Controlled release / sustained releases/delayed release products i.e. Floating drug delivery system (Mosappiride Citrate SR & Pentoprazole Enteric coated Tablets /Colon drug delivery system (Theophylline tablet/ and Fluconazole Tablet).
Formulations Scientist (I.V. Fluid, IV Admixtures)
Dawadmi Research Center & King Fahad Medical City Research Centre
03.2002 - 04.2005
- Company Overview: (MOH) Saudi Arabia
- Looking after entire gamut of Formulations functions: Formulation of different dosage forms (Sterile - Small volume, Large Volume, I.V. Fluid, T.P.N IV Injectable Admixtures).
- (MOH) Saudi Arabia
- Developed Sterile formulation & launched different TPN injectable Admixtures as per patient's requirements.
- Developed IV, Vitamins, Minerals & Protein, Carbohydrate IV. Injectable.
Formulation scientist & Regulatory Filling
Biological Evans Ltd
02.2000 - 02.2002
- Company Overview: India
- Formulation & process development for Biological products (Vaccines- Rabies, Hepatitis B, Tetanus Toxoid) & Injectable.
- Compiled, reviewed & authored & global regulatory CMC/Quality submissions to CDSCO, USFDA market.
- Provided support in planning, coordinating, managing the development, preparation and submission of the CMC sections of pre & post product dossiers.
- India
Education
Ph. D. - PHARMACEUTICS
Sunrise University
M. Pharm. - PHARMACEUTICS
Rajiv Gandhi University of health & sciences
B. Pharm. - PHARMACY
Gulbarga University
MBA - PROJECT MANAGEMENT
McGill University
08.2025
Languages
English
Arabic
Hindi
Personal Information
- Passport Number: AY059987
- Citizenship: Canadian Citizen
- Nationality: Canadian Citizen
- Marital Status: Married
List Of Products Developed
- Sildenafil 50 /100mg tab
- Tadalafil 5/10/20 mg
- Dapoxetine 30/60 mg tablet
- Escitalopram 10/20mg tab
- Lamotrigine 25/50/100mg Tab
- Clopidogrel 75 mg tab
- Pregabalin 50/75/150 mg cap
- Fosinopril 10/20/40mg tab
- Valsartan 80/160mg tab
- Donepezil 5 mg tab
- Montelukast 10 mg tab
- Irbisartan 150/300 mg tab
- Sumatriptan 50 /100mg tab
- Pioglitazone 15/30/45mg tab
- Losartan 50/100 mg tab
- Paroxetine 20/30/40 mg tab
- Tizanidine 2/4 mg tab
- Olanzapine 2.5/5/7.5/10/15/20 mg tab
- Quetiapine 25/100/200/300mg tab
- Glimepiride 1/2/3 mg tab
- Gabapentin 100/300/400mg cap
- Venlafaxine 37.5/50/75 mg tab
- Alendronate Sodium 35/70 mg tab
- Candesartan 4/8/16/32 mg tab
- Metformin 500/850/1000 mg tab
- Carvedilol 6.25/12.5/25 mg tab
- Bethistine 8/16/24 mg tab
- Acarbose 25/50/100mg tab
- Terbinafine 250mg cap
- Setraline 50/100mg tab
- Mirtazapine 15/30/45mg tab
- Sildenafil citrate tab FC
- Montelukast tablets FC
- Chewable tab
Major Cost Effective Projects Introduced
- Introduced prediction of new product shelf life in 14 days by implementing ASAP (accelerated stability assessment program) software.
- Developed 100% virtual bioequivalence (prediction of pharmacokinetic profiles) using GASTRO-PLUS SIMULATIONS software.
- Curtailed up to 40% analytical development and validation timeline by introducing Fusion software based Analytical platforming.
- Eliminated batch size scaling up of several small volumes potent drug by implementing Single cycle development (Same pilot equipment used for commercial production).
- Curtailed processing time and cost up to 25% by implementing Single use technology for sterile products.
- Curtailed source of variability and cost by fixing batch size and introducing continuous production for high volume products.
- Introduced hybrid approach for formulation development.
List Of Publications
Design and development of aceclofenac fast dissolving tablets by vacuum drying techniques., Globus: An international journal of medical science, engineering and technology, 2014-07-01, 3, 2, 2319-8958, Formulation and evaluation of lornoxicam fast dissolving tablets solid dispersion technique., Cosmos: Journal of engineering & technology, 2014-07-01, 4, 2, 2231-4210, Preparation and Evaluation of Ziprasidone Fast Dissolving Tablets by Direct Compression Method., Journal of pharmaceutical sciences and bioscientific research (JPSBR), 2017-01-01, 7, 2, Thinking Beyond QbD: Risk Smart Development & Technology Transfer., World Pharma Congress on Pharmaceutical Sciences, 2018-09-28, Montreal, Canada, A study of dissolving tablets by novel techniques., National conference in joint Auspices of National Social Science Association and Globus Institute of education and research, 2013-12-09, India, An Overview on orally fast dissolving tablets, development & technology., International conference, International Institute of advanced research (IIAR), 2016-01-17, India
Timeline
Manager (Head) - R&D, Formulation Development, Technology Transfer, Development QA
Raised Pharma
06.2024 - Current
Manager - R&D, Formulation Development, Technology Transfer, Development QA
Thermofisher Scientific
01.2019 - 05.2024
Manager - R&D and Regulatory File Preparation
Advanced Orthomolecular Research
10.2017 - 11.2018
Supervisor - R&D Formulation Development & Regulatory File Preparation
Riyadh Pharma
08.2015 - 08.2017
Supervisor - R&D Formulation Development & Regulatory File Preparation
HIKMA
05.2014 - 06.2015
Sr. Formulation Research Scientist - R&D
Taro Pharmaceuticals
07.2008 - 05.2010
Dy, Manager -Formulation (R&D)
Falma Laboratories
06.2005 - 05.2008
Formulations Scientist (I.V. Fluid, IV Admixtures)
Dawadmi Research Center & King Fahad Medical City Research Centre
03.2002 - 04.2005
Formulation scientist & Regulatory Filling
Biological Evans Ltd
02.2000 - 02.2002
Ph. D. - PHARMACEUTICS
Sunrise University
M. Pharm. - PHARMACEUTICS
Rajiv Gandhi University of health & sciences
B. Pharm. - PHARMACY
Gulbarga University
MBA - PROJECT MANAGEMENT
McGill University
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