Abid (R.) M.
Principal Scientist-QC, Analytical Sciences & Technology Transfer
Experience
Jan 2025 - Present
11 monthsPrincipal Scientist-QC, Analytical Sciences & Technology Transfer
RoslinCT
- Lead the authoring and review of qualification, verification, and validation protocols, test methods, and reports supporting advanced cell therapy products in late-stage development and commercial phases.
- Drive method lifecycle strategy and execution, including transfer, qualification, validation, compendial verification, and ongoing performance monitoring.
- Serve as the technical lead in establishing external contract testing, ensuring seamless execution and scientific rigor across partner labs.
- Oversee QC equipment onboarding and qualification, ensuring full compliance with 21 CFR Part 11 and readiness for GMP operations.
- Own and resolve complex investigations, deviations, change controls, and CAPAs, maintaining compliance and operational excellence.
- Act as subject matter expert (SME) for analytical methods — developing training strategy, authoring training content, and onboarding QC personnel.
- Provide technical leadership across cross-functional teams including Analytical Development, Quality Assurance, and Program Management to align project objectives.
- Represent QC and analytical interests in external technical discussions related to method transfer and validation activities.
Dec 2024 - Present
1 yearCMC & Analytical Strategy
Independent Consultant
- Provided recommendations that addressed bottlenecks in assay development, in-process testing, and regulatory strategy for CGT programs.
- Contributed to shaping control strategies and analytical frameworks that were later implemented by internal teams.
- Currently building AI/ML-powered platforms to streamline development and decision-making in:
- Predictive modeling of potency and quality for CMC.
- Parallel line bioassay analysis and cytotoxicity classifiers.
- Cytokine fingerprinting, stability simulations, and DoE-based stimulation tools.
- Regulatory document automation and AI-enhanced content generation.
Feb 2024 - Present
1 year 10 monthsBiology Modeling Consultant/Collaborator
Aligned AI and Outlier
- Predictive modeling of potency and quality for CMC
- Parallel line bioassay analysis and cytotoxicity classifiers
- Cytokine fingerprinting, stability simulations, and DoE-based stimulation tools
- Regulatory document automation and AI-enhanced content generation
Feb 2022 - Nov 2024
2 years 10 monthsSenior Manager Clinical Stage Analytical Development
Takeda Pharmaceuticals
- Led analytical and CMC strategy for early- and late-phase clinical programs focused on allogeneic cell therapies (CAR-T and CAR-NK).
- Directed cross-functional teams for assay and CMC strategy development across drug products, viral vectors, cell banks, and final cell therapies, with emphasis on QbD in potency assays, functional cell-based assays, and molecular impurity assessments.
- Developed, qualified, and implemented a range of analytical methods to support GMP batch release and clinical readiness within aggressive timelines.
- Managed assay tech transfers to QC labs and external CDMOs/CROs; built testing capabilities and maintained quality partnerships with global vendors.
- Authored method development, qualification, and validation protocols/reports in compliance with ICH, FDA, and EMA regulatory standards.
- Contributed to regulatory submissions, including IND and IMPD modules, supporting successful advancement of clinical programs.
- Established GMP-compliant laboratory infrastructure, including implementation of NGS-based testing for GMP-grade materials.
Jan 2020 - Jan 2022
2 years 1 monthScientist II Analytical Development
Ultragenyx Gene Therapy
- Led development, qualification, and validation of cell-, gene-, and protein-based potency assays to support early- and late-stage clinical development of AAV gene therapy programs.
- Developed and optimized robust analytical methods aligned with phase-appropriate regulatory requirements for clinical-stage assets, including GSD1a and Duchenne Muscular Dystrophy.
- Contributed to regulatory filings by collaborating across discovery and development teams to accelerate IND, IMPD, and BLA submissions.
- Analyzed and interpreted complex statistical data, ensuring cross-functional alignment with CMC and project teams.
- Influenced strategic direction by providing scientific leadership, cross-functional communication, and data-driven decision-making to align program goals with broader organizational priorities.
- Collaborated with research and manufacturing groups to translate discovery findings and assay data into scalable, phase-appropriate manufacturing processes.
- Championed scientific rigor and documentation, maintaining 100% traceability of experimental data in compliance with regulatory expectations.
- Mentored and trained junior scientists, fostering a high-performing, technically driven team environment.
Sep 2019 - Dec 2019
4 monthsScientist Consultant (Contract) - Enzyme, replacement & disruption of NET- Immune complexes (Biologics)
Neutrolis Therapeutics
Nov 2016 - Aug 2019
2 years 10 monthsSenior Research Scientist and Investigator
Inova Schar Cancer Institute
- Principal Investigator leading a molecular cancer therapy program focused on the role of MCL-1 in DNA repair and apoptosis.
- Designed and executed high-throughput drug screens to identify MCL-1–targeting compounds and elucidated their mechanisms in cancer cell death.
- Developed and validated multiple in vitro assays (cell viability, clonogenic survival, HR/NHEJ fluorescence reporters) to assess drug cytotoxicity and DNA repair competency.
- Generated and characterized colorectal and glioblastoma mouse models to demonstrate that Everolimus/AZD2014 synergize with PARP inhibitors (Olaparib) for enhanced tumor inhibition.
- Established a novel syngeneic rectal cancer model to reveal that oncolytic adenovirus and oxaliplatin cooperate to trigger immunogenic cell death.
- Engineered a modified chimeric adenovirus using Gateway cloning and Gibson assembly; performed CRISPR/Cas9 screens for MCL-1 knockout and Co-IP studies to uncover its interaction with DNA repair pathways.
- Presented research at premier conferences including AACR, Gordon Conference, Keystone Symposia, and Cold Spring Harbor.
Oct 2014 - Oct 2016
2 years 1 monthStaff Scientist
Houston Methodist Research Institute
- Discovered a novel role of MCL-1 in homologous recombination (HR), advancing mechanistic understanding of the DNA damage response and repair.
- Designed, optimized, and validated fluorescent-based HR and NHEJ reporter assays to investigate key DNA repair pathways.
- Applied advanced techniques including immunostaining, DNA fiber assays, end resection assays, and ChIP to characterize the role of MCL-1, SMARCAD1, and β2-spectrin in DNA repair mechanisms.
- Engineered stable mammalian cell lines for HDR and NHEJ functional assays, creating reproducible and high-throughput platforms for mechanistic studies.
- Led and mentored two scientists, providing technical guidance and supporting their professional development.
Feb 2009 - Sep 2014
5 years 8 monthsPostdoctoral Fellow (Biologics, Gene Therapy and Small molecules)
National Cancer Institute
- Pioneered novel therapeutic strategies in cancer biology, demonstrating that antibody-drug conjugates (ADCs) induce synthetic lethality in small cell lung cancer (SCLC) xenografts when combined with BH3 mimetics via MCL-1 depletion.
- Identified PKC kinase inhibition as a synergistic target via high-throughput siRNA screening, enhancing the efficacy of the anti-mesothelin immunotoxin SS1P across pancreatic, mesothelioma, and cervical cancer models.
- Established that LVV-mediated knockdown of NANOG/NANOGP8 decreases MCL-1 expression and sensitizes colorectal carcinoma cells to BH3 mimetics, resulting in tumor growth suppression in xenografts.
- Demonstrated that oncolytic adenovirus–delivered shRNA targeting NANOG/NANOGP8 reduces cancer stemness and inhibits tumor progression in colorectal cancer murine models.
Summary
Drug discovery and development expert with 10+ years of experience across biologics (ADCs), cell and gene therapies, oncology, and rare diseases. Skilled in advancing programs from target discovery through preclinical and clinical development in academia, biotech, and pharma. Expertise in MoA elucidation, cancer resistance, and in vivo modeling. Proven ability to integrate discovery biology with analytical and CMC strategy, supporting assay development, tech transfer, and regulatory filings (IND, IMPD, BLA). Strong cross-functional leader with a track record in CDMO/CRO management, mentoring, and strategic program execution. Committed to translating innovation into impactful therapies for patients with high unmet needs.
Languages
English
AdvancedEducation
Council of Scientific and Industrial Research–Institute of Genomics and Integrative Biology
Doctor of Philosophy · Biotechnology · New Delhi, India
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