Sasikiran Reddy Sangireddy
Minaris Regenerative Medicine
WHARTON,NJ
1
Language
1
Certification
12
years of professional experience
Accomplished PhD‑level Quality Control professional with over 10 years of experience in GMP‑regulated biotechnology and biopharma environments. Strong background in gene synthesis operations, analytical testing, and QC laboratory management. Proven expertise in product release, OOS/OOT investigations, CAPA, method validation, stability programs, and regulatory inspection support. Experienced in establishing and leading QC laboratories, developing SOPs and protocols, and ensuring compliance with FDA, cGMP, GxP, CLIA, and ISO standards. Technically proficient in flow cytometry, ELISA, qPCR/RT‑PCR, NGS, and scientific data analysis using SAS and bioinformatics tools. Recognized for driving operational efficiency, strengthening quality systems, and leading cross‑functional teams to support commercial manufacturing and clinical programs.
Work History
QC Analytical Associate Manager
2 Years 9 Months- Supervise activities of the QC Analytical Laboratory ensuring compliance with GMP, cGMP, GxP, and FDA regulations.
- Responsible for quality control review and release of finished and semi-finished products.
- Schedule and manage routine and non-routine testing of in-process, finished product, and stability samples.
- Review executed data for assays including appearance, mycoplasma, endotoxin, sterility, NC-200 cell counting, Flow Cytometry, ELISA, Bio Burden, and CBC to ensure accuracy and regulatory compliance.
- Reviewed and released finished and semi-finished products for quality control.
- Created, reviewed, and approved Certificates of Analysis (CoA), analytical reports, stability reports, and batch record documentation to ensure accuracy and regulatory compliance.
- Conducted OOS/OOT investigations, deviations, change controls, and CAPA to ensure compliance with Quality Systems requirements.
- Manage stability program including protocol development, report approval, and ongoing sample monitoring.
- Support internal audits, regulatory inspections, and Quality Metrics reporting.
- Supported internal audits and regulatory inspections, contributing to effective Quality Metrics reporting.
- Serve as QC representative and subject matter expert in cross-functional and project meetings.
- Manage and develop QC personnel including training, task assignment, and performance oversight.
- Assist in preparation of regulatory dossiers and data packages for submission to health authorities.
- Contributed to Cell, Gene Therapy, and CAR-T Therapy projects supporting clinical and commercial manufacturing.
QC Supervisor and Hybridoma Departments
2 Years- Established QC and Hybridoma departments.
- Optimized Gene Synthesis QC and hybridoma lab processes, including super coil tests, endotoxin tests, bio burden tests, and phase contamination assays to support QC operations and align the organization for growth.
- Accelerated product turnaround time through managing materials and providing oversight in allocating resources to the appropriate team.
- Drafted work instructions for production processes to ensure consistency and quality standards. for new production processes.
- Forged solid rapport with production and maintenance teams to analyze and initiate production processes while overseeing quality standards and participating in professional development training.
- Accelerated product turnaround time by managing materials and overseeing resource allocation to ensure appropriate team support.
- Drafted WIs for new production processes.
Senior Lab Specialist
7 Months- Prepared libraries for whole genome and whole exome sequencing using various methods in Next Generation Sequencing Lab focused on clinical research.
- Executed experiments for clinical certification by preparing whole genome and whole exome libraries, ensuring compliance with company standards.
- Operated liquid handlers in Next Generation Sequencing lab to automate sample processing.
- Contributed to operations in a CLIA Certified Lab, ensuring compliance with clinical standards.
- Led cross-functional teams to streamline laboratory workflows and enhance operational efficiency.
- Developed and implemented standard operating procedures to improve accuracy in laboratory processes.
- Mentored junior staff, fostering skill development and ensuring adherence to safety protocols.
- Analyzed complex data sets to support research initiatives and drive evidence-based decisions.
Wastewater Testing Manager
1 Year- Managed R&D projects for molecular biology, including COVID identification in wastewater samples across Kentucky using qPCR.
- Established wastewater testing laboratory for COVID-19 detection, implementing qPCR methodologies to enhance testing capacity.
- Led and managed R&D projects focused on molecular biology applications, including SARS-CoV-2 identification in wastewater samples across the Kentucky region.
- Collaborated with University of Louisville to implement wastewater surveillance testing programs, supporting public health monitoring efforts.
- Collaborated with the University of Louisville, KY to implement and support wastewater surveillance testing programs.
- Developed and authored Work Instructions (WIs) and standardized procedures for wastewater testing operations.
- Managed and supervised a team of 4 laboratory personnel, providing training, task delegation, and performance oversight.
- Oversaw sample processing, data analysis, reporting, and quality compliance for molecular testing programs.
- Led testing teams to ensure compliance with regulatory standards and quality protocols.
- Developed and implemented testing strategies to enhance product reliability and performance.
- Streamlined testing processes, resulting in improved efficiency and reduced turnaround times.
- Mentored junior staff on best practices in testing methodologies and data analysis techniques.
Senior Scientist
2 Years 5 Months- Led gene synthesis operations.
- Proven technical expertise with Sanger sequencing using ABI capillary instruments and DNA related molecular biology techniques and data analysis.
- Experienced in oligo nucleotide synthesis using BLB and Oligo Co.
- Analysis/purification of Oligo nucleotides by Mass Spec, Capillary Electrophoresis, PAGE or HPLC.
- Thorough understanding of oligonucleotide chemistry including phosphoramidite bases synthesis methods, de protection and purification methods and post synthetic labelling chemistry.
- Experienced in oligonucleotides quality control including MALDI-Tof, HPLC analysis and capillary gel electrophoresis.
- Proficient in operating oligonucleotide purification and automates synthesis equipment.
- Proficient in using high throughput robotic equipment for liquid handling.
- Effectively managing personnel, and material resources to ensure timely release of the product.
- Managed personnel and material resources to ensure timely product release.
- Identified products to enhance quality, reduce costs, and improve turnaround time.
- Documented and analyzed experimental data.
- Demonstrated knowledge of ISO standards and procedures..
- Decontamination efforts and area monitoring in labs by using q PCR techniques.
- Led cross-functional teams to develop innovative genomic solutions and enhance research capabilities.
- Mentored junior scientists, fostering professional growth and improving laboratory techniques.
- Designed and implemented experimental protocols to optimize DNA sequencing processes.
Scientist Group Leader
2 Years 10 Months- Developed, evaluated, validated, and implemented processes for gene synthesis, Gibson cloning, and sub-cloning to enhance laboratory capabilities.
- Maintained comprehensive understanding of laboratory procedures and operations. of all laboratory procedures and operations in order to provide informed answers to employees and other departments.
- Collecting, documenting and analyzing experimental data to improve current production processes.
- Organized stocks of DNA, bacteria, and electronic maps.
- Collected, documented, and analyzed experimental data to optimize production processes and ensure quality standards.
- Coordinating with production and maintenance to evaluate and implement new equipment and processes.
- Wrote work instructions for new production processes, trained production personnel, and supervised implementation to ensure compliance and efficiency.
- Keeps a solid understanding of all laboratory procedures and operations in order to provide informed answers to employees and other departments.
- Successfully completing any required training and ensuring Quality Standards are maintained.
- Conducted research on gene sequencing techniques to enhance product offerings.
- Developed and optimized protocols for DNA/RNA extraction processes.
- Collaborated with cross-functional teams to streamline laboratory workflows.
- Mentored junior scientists on best practices in molecular biology techniques.
Education
Ph.D. - Biology (Molecular Biology)
MS - Plant Sciences
MBA - Agribusiness Management
BS - Agriculture
Skills
Quality Control & Quality Assurance (GMP / cGMP / GxP
CLIA
ISO)
OOS/OOT Investigations
Deviations
CAPA
Change Control
Product Release
Batch Record Review & Certificate of Analysis (CoA) Approval
Method Validation
Method Transfer & Stability Program Management
Regulatory Dossier Preparation & Audit/Inspection Support
SOP & Work Instruction Development; Documentation Control
Equipment Qualification (IQ/OQ/PQ)
Calibration & Environmental Monitoring
Sterility
Endotoxin
Mycoplasma & Bioburden Testing
Flow Cytometry
ELISA
NC200 Cell Counting
PCR
qPCR
RT‑PCR & Molecular Testing
Gene Synthesis and Next Generation Sequencing (NGS) & Sanger Sequencing
Data Analysis using SAS & Bioinformatics Tools
Certification
BASE SAS
Languages
English
Timeline
QC Analytical Associate Manager
Minaris Regenerative Medicine
11.2023 - CurrentRead More
QC Supervisor and Hybridoma Departments
GenScript USA Inc.
10.2021 - 10.2023Read More
Senior Lab Specialist
Discovery Lifesciences
03.2021 - 10.2021Read More
Wastewater Testing Manager
Eurofins Genomics LLC
03.2020 - 03.2021Read More
Senior Scientist
Eurofins Genomics LLC
10.2017 - 03.2020Read More
Scientist Group Leader
Eurofins Genomics MWG Operon
12.2014 - 10.2017Read More
Acharya NG Ranga Agriculture University
BS from Agriculture
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Acharya NG Ranga Agriculture University
MBA from Agribusiness Management
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Tennessee State University
Ph.D. from Biology (Molecular Biology)
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Alabama A&M University
MS from Plant Sciences
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Visa Status
I have US Citizenship