Deepti Sala
New Brunswick,USA
Summary
Pursuing a challenging role to advance in the field of Industrial Microbiology.
Resourceful individual who can work efficiently while paying attention to detail. Works well independently and within a team and takes pride in producing accurate results in the laboratory. Experienced in conducting comprehensive scientific research and data analysis projects, with a focus on Microbiology, molecular biology and biochemistry. Strengths include innovative problem-solving skills, adeptness at laboratory management, and ability to communicate complex information effectively. Track record of contributing significantly to team-driven research outcomes and delivering high-quality results.
Overview
9
9
years of professional experience
Work History
Associate Research scientist, Microbiology center of excellence
Bristol-Myers Squibb Company
New Brunswick, NJ
01.2022 - Current
- Perform protocol-driven microbiological testing, such as bioburden, endotoxin, microbial identifications, molecular testing for mycoplasma, in-use hold time studies, and studies for investigational support.
- Subject matter expert in non-routine and routine testing.
- Supporting automation through support for novel technologies, with a business case for EM, mycoplasma, rapid bioburden, and sterility.
- Completed method qualification for the new rapid technology, the MSID Microseq Microbial Identification System.
- Supported the three-lot validation for CAR-T samples, which can help transition traditional PCR testing to rapid mycoplasma testing, reducing the time needed to deliver medicines to patients, and eliminating many risks in handling samples and errors. I also contributed to the first patient CAR-T sample validation for mycoplasma testing. In addition to routine testing of RCBs, I supported the commercial release of mycoplasma testing for various CAR-T products.
- High proficiency in all tests, techniques, and background principles of every procedure and method within the micro area of expertise.
- Write, revise, and review SOPs and test methods.
- Provided microbiological support for the development and manufacture of oral solid, and parenteral clinical supplies.
- Responsible for the analysis and documentation of microbiological testing and data in compliance with regulatory, GMP, and departmental SOP requirements.
- Accountable for technical support for in-process, release, and stability microbiological methods for drug products and drug substances.
- Performed troubleshooting to solve analytical and other microbiological-related problems, to determine remedial steps to resume testing, guarantee compliance, and prevent recurrence.
- Lead constant lab flow efficiency improvements (MPS), and contribute ideas on how to improve existing systems.
- Served as a liaison between quality control and other functional groups to ensure that current microbiological method issues were properly addressed.
- Management of deviations in a timely manner.
- Served as the Microbiology SME for various drug products, including small molecules, biologics, and CAR-T, and is responsible for working with cross-functional teams, clinical supply operations, recommending the sampling and methods, as well as assuring that the in-process and release testing for the products is performed in compliance with regulatory requirements.
- Instrumental in much of the endotoxin testing, including, but not limited to, DP release, raw material qualification, LER studies, and transitioning network testing from gel clot to kinetic testing.
- Also, I am very involved in the recombinant reagent comparability study.
- Evaluated and appraised method changes with regard to regulatory requirements.
- Executed instrument qualification studies as per approved protocols.
- Perform required maintenance on laboratory equipment and automation systems.
- Observe and evaluate existing laboratory practices, and propose alternative approaches to simplify and streamline ways of working.
- Supported the implementation of electronic records and laboratory automation system projects.
- Supported the evaluation and implementation of novel methods.
- Contributed an ideal amount of time for training and cross-training in the lab.
- Carries out analytical tests and inspections in connection with the investigation of product and EM excursions.
- Executed in-use microbiological hold time studies, stability assessment for intravenous solutions, as requested by regulatory agencies.
- Maintained field equipment and performed troubleshooting techniques to keep tools fully operational.
- Recommended new systems and processes to improve operations.
- Collaborated with undergraduate and graduate students to provide research guidance and supervision.
- Prepared scientific presentations summarizing study results for internal meetings and external conferences.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
Bacteriologist
Bristol-Myers Squibb Company
New Brunswick, NJ
09.2018 - 12.2021
- Performs Microbiological testing (Growth promotion, HPC, Bacterial endotoxin) to ensure that the proper standards of quality are maintained
- Performs microbiological, bacterial Endotoxin, and TOC Conductivity analysis of water system samples
- Demonstrates the use of an aseptic technique
- Analyses develop & recommend a new method for the improvement of various standard assays & tests
- Supported Qualification protocol for animal component-free TSB media for aseptic process simulation
- Coordinated with management to execute Micro–Dry goods Hold time study protocol for autoclaving to support the establishment of hold time for sterilized equipment and materials used in ASO- Microbiology lab
- Contributed the ideal amount of time for training and cross-training in the lab
- Works with cross-functional teams to support parenteral drug manufacturing
- Participated in aseptic Media fill simulations as SME to support media fill Growth promotion on different batches
- Preservation of Environmental isolates and Maintenance of Frozen cultures in the lab to support various studies
QC Microbiologist
L’Oréal USA Inc.
Piscataway, NJ
06.2017 - 08.2018
- Performed microbiological testing of raw materials, finished goods &bulk in accordance with L’Oréal, GMP, FDA and DGO requirements
- Carefully read and tabulated test results entering all data into SAP or paperwork as needed
- Conducted laboratory and production equipment validation to ensure compliance
- Reviewed equipment charts for specification compliance &temperature monitoring
- Provided method development for Quality Management, Manufacturing processes and for R&D experimental formulations
- Assumed leadership for completion of numerous projects assigned by the supervisor
- Reviewed & evaluated raw materials and data for acceptability
- Participated in issues regarding audits and commitments
- Reduced reoccurrence of out-of-specification (OOS) investigations by identifying root causes using procedures and process checklists with proper CAPA
- Coordinated with laboratory personnel for a weekly inventory of testing supplies, temperature monitoring (daily)
- Engaged in Environmental monitoring for water sample Collection, testing and evaluating equipment, facility surfaces &atmospheric conditions using swabbing, RCS air sampler, settle plates and membrane filtration technique
- Increased workflow and productivity by organizing workflow and streamlining worksheets to be user friendly
- Achieved continual safety awareness and work practices through implemented safety procedures
- Participated in validation activities for compendia microbial methods
- Participated & conducted RCA & take appropriate corrective& preventive actions (CAPA)
- Utilized SAP to record all work orders in compliance with Loreal methods
- Adhered to Good documentation practices, SOP, cGMP, and FDA and DGO requirements
QC Microbiologist
Manhattan Drug Industry
Hillside, NJ
06.2016 - 05.2017
- Managed daily activities in the microbiology laboratory
- Routine microbiological analysis of raw materials, bulk & finished products using Bio Lumix
- Prepared samples for vials using Bio Lumix for microbial enumeration according to SOP
- Reviewed and evaluated raw materials &finished products for acceptability
- Prepared &qualified various microbial media used in product &water testing (Growth Promotion)
- Maintained weekly inventory of testing supplies, temperature monitoring (daily), water samples Collection &testing for environmental monitoring in production, encapsulation and Packaging areas
- Conducted EM &personnel monitoring during batch production and filling and prepared quarterly trend reports for environmental, water and clean utilities monitoring
- Ensure all laboratory equipment are maintained and calibrated as per established schedule
- Maintained the integrity of the laboratory through the introduction of weekly lab cleaning and Maintenance procedures
- Adhered to SOP, cGMP, and FDA requirements
Education
Master of Science - Microbiology
Andhra University
Bachelor of Science - Biotechnology, Biochemistry, Microbiology
Andhra University
Skills
- Analysis of raw materials and finished products using Biolumix
- Environmental Monitoring
- Cell culture
- Industrial Microbiology
- SAP
- RCA
- CAPA
- USP
- Chromatography
- DNA sequencing
- Molecular biology
- Immunohistochemistry
- Aseptic technique
- PCR
- CGMP
- Bioassay
- Serological and immunological techniques
- Staining Techniques
- HACCP
- Electrophoresis
- Velquest
- PDLIMS
- Endoscan
- Endozyme
- BAC-T Sterility
- MODA
- BIOFIRE
- MSID Microseq Microbial Identification System
- Auto extraction
- MVM
Projects
Training on Immunological, Molecular & Mammalian cell culture techniques, GIMSR, 06/2008 - 01/2009 Industrial Training & Internship in Biocon (Industrial Microbiology), 06/2008 - 01/2009 Business Email writing & communication workshop, 06/2008 - 01/2009
Timeline
Associate Research scientist, Microbiology center of excellence
Bristol-Myers Squibb Company
01.2022 - Current
Bacteriologist
Bristol-Myers Squibb Company
09.2018 - 12.2021
QC Microbiologist
L’Oréal USA Inc.
06.2017 - 08.2018
QC Microbiologist
Manhattan Drug Industry
06.2016 - 05.2017
Master of Science - Microbiology
Andhra University
Bachelor of Science - Biotechnology, Biochemistry, Microbiology
Andhra University
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