Huma Rasool Email & Phone Number

Portland, OR, US

South San Francisco, California, US

• Supported multi-stage start-up of Genentech’s state-of-the-art cell and gene therapy manufacturing facility in Hillsboro, OR, for the development and manufacture of the novel mRNA based Individualized.
• Lead Quality Engineer for facility design, process and analytical transfers, commissioning & qualification of systems, shipping validation and development of a risk-based manufacturing approach for multiple T-cell.
• Lead Quality Engineer for implementation of analytical methods for cell and gene therapies

South San Francisco, California, US

• Provided Quality, Engineering and Validation expertise to ensure processes, systems and documentation are robust and compliant with Health Authority expectations
• Site Quality lead for anti-Myostatin Adnectin-Fc, and co-lead for Mosunetuzumab Process Performance Qualification and BLA filing
• Identified challenges and developed solutions for local implementation of Pharma Quality Systems (PQS)
• Participated in audit preparation and support groups in defending executed validation activities with regulatory agencies
• Facilitated the Site Risk Management governance team**Participated in Genentech's NextGen Leadership Forum (Winter 2017-18) - see volunteering.

South San Francisco, California, US

• In addition to Process Engineer I duties,
• Analyzed changes in risk profile for buffer preparation and bulk filtration processes at SSFP as the risk assessment owner to ensure compliance with the site Quality Risk Management program
• Provided expertise for development of placebo run cleaning strategy to support the NPI cleaning program at SSFP
• Represented department on cross-functional production campaign readiness teams to enable efficient start-ups and problem solving

South San Francisco, California, US

• In addition to Associate Process Engineer responsibilities,
• Successfully led Lampalizumab Process Performance Qualification campaign from planning through execution completion as the Downstream lead
• Managed engineering interns through a combination of project and role based support
• Collaborated with Process Development to solve technical issues related to scale-up and tech transfer
• Serve as a site representative and owned CAPAs for implementation of enhanced microbial controls in chromatography operations
• Implemented process improvements for enhanced microbial control in removal and return to service procedures for manufacturing equipment by streamlining site changeover requirements

South San Francisco, California, US

• Hired in the New Hire Pool rotational program in the SSF Production/Manufacturing Sciences and Technology group. Rotated in the Drug Substance Purification group.
• Provided downstream/purification technical support for GMP production of CHO and E. coli derived clinical and commercial drug substances, including timely discrepancy and investigation evaluations
• Authored and executed UF/DF membrane carryover process validation study for Nutropin (rhGH) ** SSFP MSAT Crush Stainless Award, May 2015 – Received department award for demonstrating great flexibility, coordination and.

Thousand Oaks, CA, US

• Efficiently executed downstream unit operations for process runs, experiments and characterization efforts in a highly dynamic, team-based environment to generate data and pre-clinical CHO and E. coli derived bulk drug.
• Accurately performed various harvest and purification unit operations in a large-scale Pilot Plant: flocculation, acid precipitation, centrifugation, chromatography (affinity, ion-exchange, hydrophobic interaction, and.
• Efficiently performed process-related duties: Column packing, buffer and media preparation, CIP/COP of fixed and portable processing equipment, and equipment set-up for harvest and downstream operations (automated.
• Provided process and project engineering support as a purification engineer by evaluating and integrating single-use bioprocessing technologies, as well as designing, commissioning, qualifying and integrating.

Los Angeles, CA, US

• Aided the research of the biochemical analysis of the biosynthetic pathway of an anticancer tetracycline SF2575
• Performed knockout gene projects to understand the functions of enzymes encoded by the ssf biosynthetic gene cluster
• Analyzed the effects on the enzymatic activity of SF2575 by introducing point mutations in the amino acid sequence of the active site
• Efficiently conducted procedures at bench-scale: Transformation, plate streaking, fermentation, mini-prep, real time PCR, DNA agarose gel electrophoresis, medium-scale protein expression, protein purification.
• Other laboratory duties included preparation of media and batch bacterial cell cultures using shake flasks and bioreactors

Bachelor Of Science (B.S.), Chemical And Biomolecular Engineering

Master Of Science (M.S.), Biotechnology

Engineering