Wasfi Alazzam, Phd Email & Phone Number

WA consultation DBA OmniBioPro Founder and CTO providing cross-functional Services in CMC, manufacturing, clinical, operations, regulatory, and supply chain. Extended services in business development, new product (instrumentations and Software) launches, technology evaluation, strategic implementations, and partnerships with CDMOs and CROs to maximize market penetration and business expansion.

Tarrytown, New York, Us

Recruit, build, and work with a great team to achieve the company’s goals. Collaborate with clinical teams, regulatory, quality teams, and other stakeholders to ensure that all project milestones and deliverables are met, and that CMC program activities are well executed and managed. Create and manage execution plans in alignment with the strategic Product Development Plan and estimated budget. Foster a collaborative team environment and manage multiple project activities to achieve CMC milestone commitments to the company’s programs and products. Interpret and integrate complex information, appreciate cultural differences internally and externally to establish and maintain relationships, effectively predict and, where necessary, efficiently execute against strategy changes, clearly communicate with internal and external stakeholders, and obtain agreement from multiple parties and influence others without direct authority.

Tokyo, Jp

Working and leading a diverse team of 13 individuals, fostering career development and driving a high-performance culture. Collaborating with an exceptional global matrix team of 50+ experts across the US, EU, Japan, and China, we enhance cross-functional synergy for successful projects.One team oversees meticulous authoring, templating, reviewing, and archival of top-tier CMC documents vital for global regulatory submissions across clinical studies and registrations in diverse markets.In parallel, another team adeptly manages CMC Ancillary M1 documents for regulatory submissions, spanning global programs across clinical and registration phases.Our efforts drive successful global regulatory submissions across modalities including biologics, vaccines, cells, genes, ADC, Oligos, and small molecules. We contribute to R&D Submission Excellence initiatives, expediting processes and ensuring seamless transitions between CMC Line Functions and Regulatory Affairs.We foster communication and collaboration among internal and external stakeholders (CRO, CMO, and CDMO) spanning CMC, Quality, Manufacturing, Clinical, and Regulatory domains.Additionally, we orchestrate an all-encompassing GXP and non-GXP training tailored to staff in diverse CMC line functions in the US, EU, and Japan.Our dedication extends to transformative initiatives like digital transformation and environmental sustainability. We manage seamless transitions to key platforms including ELN, LMS, and DMS on a global scale. Our involvement spans documentation archiving within the R&D Documentation Records and Information Management (RIM) team.

• Provided strategic CMC consultation and testing services, delivering valuable insights to diversepharmaceutical innovators and manufacturers.• Managed end-to-end product development for early and late-stage projects across a wide range ofmodalities, including biologics, vaccines, cell, LNP, mRNA, RNA, ADC, exosomes, and gene therapies.• Oversaw development of upstream processes involving mammalian, insect, bacterial, and yeast cells,followed by meticulous downstream purification steps such as clarification, filtration, and variouschromatography techniques (affinity, ion exchange, size exclusion, hydrophobic interaction, precipitation).• Directed ultrafiltration/diafiltration, viral inactivation, formulation, and fill/finish processes.• Expertly managed development of production processes, analytical methods, and formulations, ensuring seamless tech transfer, qualification, validation, and successful implementation at manufacturing facilities.• Conducted thorough risk assessment, mitigation plans, incident investigations, performed root causeanalysis, and implemented CAPA initiatives, fostering continuous improvement and maintaining compliance with industry standards.• Led process validation efforts, utilizing data mining and statistical analysis methodologies like Design ofExperiments (DOE) and Quality by Design (QBD) approaches. Developed NORs (Normal Operating Ranges), PARs (Process Analytical Ranges), and DSp (Design Space) for manufacturing processes.• Collaborated with clinical teams, regulatory authorities, and technical writers to successfully manage all of CMC development process.• Reviewed, drafted, and addressed questions for regulatory submissions, ensuring adherence to stringent regulatory requirements.• Provided critical support to intellectual property teams, evaluating data, identifying potential infringement issues, acting as an expert witness, and contributing to the drafting of patents.

Brentford, Middlesex, Gb

Held several roles with increasing levels of responsibility at GSK – Investigator, Associate GSK Fellow, GSK Fellow, R&D Analytical Team Leader, and CMC Team Leader.• Team Leader: Led global CMC teams across multiple sites, and consistently delivered business objectives for Rare Disease, Respiratory, and Oncology indications. Scientifically directed process development including radio labeling, formulation, analytical, and stability studies for multiple modalities (e.g., mAb, dAb, and liposomes). Managed incidents investigation and CAPA closure. Led data integrity and documentation in different quality systems. Performed due diligence on CMC and clinical sites to ensure readiness of production and clinical trials, identified risks and mitigation plans. Managed challenges of clinical batches and supply across borders to dose within 48 hrs. Briefed regulatory agencies and managed drafting regulatory documents to initiate clinical trials. Interfaced with clinical team and ensured proper delivery device, co-authored clinical protocol, and clinical report. Conducted due diligence and management of CMO. • R&D Leader: Recruited & mentored R&D team members and expanded the group capabilities. Prepared yearly objectives and supported staff’s development. Designed lab space, recruited cutting edge technologies, and developed novel methods. Evaluated and managed external organizations to help business plans and goals timely and quality. Authored and reviewed characterization sections for products at various stages for regulatory submissions. Supported marketed products characterization, formulation, and stability of Tanzeum®, Arzerra®, and MEPO®. Developed technology and methodology, qualified, and implemented at manufacturing to monitor clinical and commercial lots. Led various investigations and CAPA closure of product development including post-marketing products.

Sant Cugat Del Vallès, Barcelona, Es

Led formulation of Antithrombin® (ATIII®) lyophilized DP manufacturing and tech transfer to NC site. Authored and reviewed tech transfer protocols and oversight PQ batches. Investigated incidents and closed CAPAs. Authored tech transfer regulatory document (ATIII®). Executed formulation development of pre-filled syringe liquid 10% Gamunex®. Developed liquid formulation of 1-protease inhibitor® modified process, managed tech transfer to pilot plant and supported Phase III clinical batches. Developed formulation of ultra-pure 1-protease inhibitor® for inhalation delivery via nebulizers. Worked with engineering group for device development. Developed lyophilized DP formulation of Plasmin® and pre-formulation package of µ-Plasmin. Developed lyophilization cycle of biotech µ-Plasmin with tech transfer from R&D to pilot plant and CMO. Authored DP sections in regulatory submission and addressed regulatory agency questions.

Leverkusen, North Rhine-Westphalia, De

Contributed to establishing formulation group including labs, technologies, staff recruitment, and staff training. Transferred formulation process to manufacturing including process qualification. Supported incidents, CAPAs, and improved manufacturing process performance. Executed pre-formulation screening of human derived plasma Fibrinogen® for skin and bone topical delivery to treat damage tissues. Prepared strategy study for topical lung delivery via nebulizer for −1 proteinese inhibitor.

Phd, Biochemistry

Master, Biotechnology

Bachelor, Biology

High School, Science