Md Asaduzzaman Forazi

I have over sixteen years of experience in cross-functional CMC environments in bioprocess R&D, Manufacturing. As I led several projects and groups from laboratory to commercial, I worked on viral vectors (ChAdOx, Ad5, Ad26, HSV-1, AAVs), VLP, antibody (MAB), antibody fragments, and other proteins, peptide conjugates, and biodegradable polymers. In these years, my skill sets developed around upstream (from bacterial, yeast and mammalian cell culture), downstream processing, formulation, drug product and analytical development.

In addition to my bioprocess skill, I have been actively engaged in supporting CDMO work and technology transfer, supporting and interacting with the supply chain, commercial and quality departments. I have also played vital role in submitting IMPD and supporting answering the queries from regulatory authorities.

During these years, I have worked in a fast-paced environment, led several teams of scientists and brought unique solutions to processes in product development using statistical software.

My goal is to contribute to global drug development with my expertise, creativity and knowledge.

Albumedix (Part of Sartorius) I Head of Viral Vector Application Research Nottingham, UK I 2022-Present

• Support business objectives in enabling advanced therapies, specifically the CMC of viral vector/vaccines, by leading the viral vector/vaccine application research group consisting of six scientists.
• Development and support of project plans to demonstrate the use of albumin in the upstream, downstream and formulation of viral vectors/vaccines, specifically for AAVs, LVs and AVs.
• Technical consulting and coordinating with external stakeholders on virus-based therapeutic vaccines, particularly on gene therapies and on viral-vector platforms.

• Supported and led investigation and incident response from Global VPAD (Vaccine Process and Analytical development) for Per.C6 cell-based Adenoviral (AV) vector Ad26 Covid Vaccine for emergency use.
• Worked with CMOs located on different continents, with internal-external GMP Facilities (e.g. Janssen, Leiden, Catalent US & Europe, GRAM-US, Aspen-South Africa, BioE India) and with external EQL laboratories (e.g., Eurofins Italy & USA) to expedite timely drug substance and drug product release.
• Supported the supply chain, tech ops, commercial quality, and external suppliers to investigate deviations and approve change controls, CAPAs and other quality-related issues.
• Responded to EMA regulatory authorities’ inquiries to enable the continuation of the AD26.COV2S vaccine’s EUA (Emergency Use Authorisation).

Spicona I Scientific Advisor (contract) Global, Remote I 2021-2022

• Provided process development advice for novel vaccines against SARS-CoV-2 (Covid-19).

VMIC, UK I Team Leader, P&AD (USP) Oxfordshire, UK I 2020-2021

• Established the upstream development laboratories (CAPEX £2.5 mil) at the brand-new VMIC facility.
•  Planned, performed and reported on upstream development projects, studies and investigations. 
• Managed cell culture process development (scale-up/scale-down of existing bioprocesses). 

Vaccitech Limited I Senior Development Scientist Oxfordshire, UK I 2019-2020

• Prepared draft CAPEX, OPEX budgets of Process Development Group for senior management approval.
• Developed USP (cell line, bioreactor, culture medium and growth / product optimisation studies (MOI, POI, POH).
• Developed DSP (cell lysis, clarification, TFF, chromatography) for viral vector (AV-based ChAdOx) and MVA (Modified Vaccinia Ankara) vaccine.
•  Determined CPP (critical process parameter), CQA (Critical quality attributes) and validated process in advance of technology transfer to CDMOs.
• Led a team of 4 scientists to Improve yield from 45% to 95% and reduce process and product-related contaminants based on the QBD approach (ICH).

Evox Therapeutics I Senior Process Development Scientist Oxfordshire, UK I 2018-2019

• Fitted out new USP and DSP labs with a mixture of new and used scientific equipment.
• Prepared procedures (SOPs), checklists, HSE documents (MSDS / biological safety level), risk assessments and monthly scientific progress reports for senior management.
• Led a team of three scientists for exosome-based therapeutic drug substance manufacture for a ‘first-of-its-kind’ toxicology study. 

SpyBiotech I Senior Scientist Oxfordshire, UK I 2017-2018

• Performed lab-scale USP development to manufacture protein and VLP vaccine candidates using yeast strains.
• Established and developed new USP, DSP and analytical methods.

AKAMIS Bio (former PsiOxus Therapeutics Ltd) I Senior Scientist, MS&T Oxfordshire, UK I 2016-2017

• Developed HEK293 and CHO-based cell culture processes in single-use (SU) bioreactors with perfusion.
• Optimised DSP development of Adenovirus vectors and reduced HCP contaminants at below-detection-limit- (BDL).
• Prepared SOPs, RAs and scientific reports and reviewed BMRs , IMPD, and IND documents.
• Led a team of two scientists for Technology-transferred lab-scale process to CDMOs (located in N. America and EU)

Amgen I Associate Scientist Oxfordshire, UK I 2013-2016

• Performed USP development (using various mammalian cells) and optimised manufacturing process for oncolytic viral vector (HSV-1) production. 
• Led late-stage process development to make two steps (SEC & TFF) more robust.
• Performed formulation and informal stability studies.
• Participated in the generation and provision of additional support documents during the FDA inspection of TVEC.

Xenetic Bioscience, Inc (formerly known as ‘Lipoxen’ I Research Scientist London, , UK I 2007-2013

• Led a group of six junior scientists and technicians to develop and optimise a USP using recombinant E. coli to secrete Polysialic Acid (PSA) in a single-use bioreactor.
• Developed and optimised a DSP for PSA. 
• Developed processes to conjugate PSA with various molecules (insulin, glucagon, EPO, DNAse) with a view to improving their bioavailability.
• Developed analytical methods (characterisation and QC release) of conjugated molecules.
• Technology-transferred laboratory-scale processes to CDMOs and prepared CTDs.

Sainsbury’s Pharmacy, I Pharmacy Counter Assistant London, UK I 2003-2007

• Dispensing medicine and helping customers with their general health-related enquiry.

Eskayef (former Smith-Kline & French) Bangladesh Limited I Sr Production Pharmacist Dhaka, Bangladesh I 1999--2003

• Planned production in various assigned areas, including Dispensing, Granulation, Blending, Compression, Coating (Sugar and Film), Blister and Foil packaging, liquid formulation and filling in the GMP manufacturing facility.
• Supervised a group of twenty production pharmacists and troubleshooted manufacturing operations, ensuring cGMP on the manufacturing floor.

University of London I MSc in Molecular and Structural Biology London, UK I 2008--2011

University of Dhaka I Master of Pharmacy Dhaka, Bangladesh I 1997-1998

University of Dhaka I Bachelor of Pharmacy Dhaka, Bangladesh I 1994-1997