Microbiology Principal Scientist

Musaddeq Hussain, PhD

Email: *******@*****.***

Cell: +1-732-***-****

Experienced task and goal-oriented scientist and manager with extensive experience working in the biopharmaceutical industry. Achieved batch release of >15 different drug substance for toxicological studies. I have achieved full cycle of analytical method starting from method developed, qualification, transfer and establishment in CRO/ QC labs. I have extensive experience in writing analytical methods, SOP, stability reports, technical reports, regulatory documents and responses, and publication of original articles in peer-reviewed journals. I want to work as a consultant or a part-time employee, in a remote or hybrid set up covering:

biologics analytical development

biologics drug program management in-house or at CRO or CMO

stability study management

documentation management, e.g., interpretation of data, prepare data for presentation, writing reports, author parts of CMC in NDA filings, answer questions from Regulatory agencies

PCR and molecular biology technical issues

Skills

Skilled in Analytical sciences, Protein Chemistry, Microbiology, Molecular Biology, and Biotechnology; method qualification/ validation; working in QC lab; establishment of testing labs; managing release tests for drug substance (tox batches); working with external labs (CRO) in managing drug substance in development; working with Regulatory in CMC management and IND filing; design and implementation of Stability Studies; manage in-process testing in supporting upstream and downstream processes; writing and reviewing documents; supporting/managing clinical studies and documentation; managing test samples using LIMS. lab management, testing schedule, troubleshooting; analytical program management of drugs in development, method establishment and transfer to CROs; general computer programs and LIMS, scientific report writing, data compilation and presentation to various conferences.

Technical skills include HPLC, PAGE, PCR, Digital PCR, protein and nucleic acid sequence analysis and primer-probe design, and other lab methods.

Recent Employment

Principal Scientist

Merck/ Schering-Plough: Sep 1999 – Dec 2021

Merck Research Labs (MRL)

I supported many biologic drug projects in development through tox batches to Phase 1 batches of drug substance; managed all analytical aspects of several projects including due diligence in CRO selection and management of CROs; I was involved in sample management and all aspects of stability studies, in-process sample testing, method development, establishment, qualification and transfer to CROs and QC labs. I managed several scientists in process impurity testing for all biologic projects at MRL.

Schering-Plough Research Institute (SPRI)

I served as Lab Manager of Clinical Molecular Biology Lab in Schering-Plough. I was fully responsible for planning and operation of the lab, evaluated analyst performance and promoted leadership behaviors. I facilitated analyst training and professional growth. I interacted with Clinical Department, clinical sites, CRAs, investigators, and other pharmaceutical companies and led projects and determined method validation/qualification needs. I applied my technical expertise in PCR assays and primer and probe design, and in DNA sequencing and sequence-based assays like genotyping and mutation analysis.

Education

Waksman Institute of Microbiology, Rutgers University

Post-doc, Molecular Biology

Nagoya University, Nagoya, Japan

Doctor of Philosophy (PhD), Microbiology

Department of Biochemistry, Dhaka University

BS and MS, Biochemistry

Languages

Bengali: Native or bilingual proficiency

English: Native or bilingual proficiency

Hindi: Limited working proficiency

Japanese: Limited working proficiency

Recent Publications

Musaddeq Hussain. Isothermal droplet digital PCR method for quantification of CHO residual DNA. Jan 2022

Musaddeq Hussain, William J. Rayfield, and David J. Roush. A direct RT qPCR method for quantification of Retrovirus-like particles in biopharmaceutical production with CHO cells. Jul 2020

Jeremy Anderson and Musaddeq Hussain. A Direct Droplet Digital PCR Method for E. coli Host Residual DNA Quantification. Jan 2018

Musaddeq Hussain and John Bowers. A Droplet Digital PCR Method for CHO Host Residual DNA Quantification in Biologic Drugs. Mar 2017

Musaddeq Hussain, Rebecca Fantuzzo, Suzanne Mercorelli and Constance Cullen. A direct droplet digital PCR method for quantification of residual DNA in protein drugs produced in yeast cells. Jan 2016

Musaddeq Hussain. A direct qPCR method for residual DNA quantification in monoclonal antibody drugs produced in CHO cells. Mar 2015

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