Associate Scientist

SAMRUDDHI B. PATIL

** ******** ******, ******, ** 08817 +1-732-***-****

acz4go@r.postjobfree.com https://www.linkedin.com/in/spatil93

SKILLS

Proficient In:

Upstream Bioprocess, Cell Culture (Aseptic Techniques)

Bioreactor Operation (15L to 200L Single Use, glass tank and stainless steel tank)

Development and execution of Process Validation Protocols, SOPs, Lifetime Study Reports

cGMP program including Risk Analysis, Change Control, and Standard Operating Procedure, Process Deviation Investigation and CAPA (Corrective Action & Preventive Action) protocol implementation, drafting Process & Equipment Reviews

Creation of sample plans, process flow diagrams, process description charts, process equipment review and protocols necessary for technology transfer operations

Pharmaceutical Unit Operations: Blending, Milling, Wet Granulation, Drying, Encapsulation, Tablet pressing

DOE and Equipment Qualification

Statistical and Multivariate Analytical Software:

The UnscramblerX, Minitab, SAS JMP, MS Excel

Additional Experience with:

HPLC, Spectroscopy (Mass, FT-IR, UV-VIS), Rheometry, Genetic Algorithm

WORK EXPERIENCE

BioPharmaceutical Technology Associate Scientist 08/2016 to Present

GlaxoSmithKline- Rockville, MD

In charge of:

Providing cross-functional project assistance and technical support for GSK's Rockville GMP commercial manufacturing facilities with upstream scales ranging from 650 L to 20,000 L.

Writing, reviewing and executing Process Validation Protocol (PVP) and Process Validation Reports, as listed in Process Validation Master Plan.

Bioreactor operation ( glass tank, stainless steel tank and single use bioreactors ranging from 15L to 500L) for DOE execution, validation and consistency and scale up studies.

Equipment qualification (Cell counter, Biochemistry Analyzer, Osmolality meter, Turbidity meter, Blood Gas Analyzer, Media Pasteurizer)

Coordinating the appropriate sampling, sample storage and documentation of sample storage.

Ensuring that assays utilized are qualified, or validated, for their intended use, as appropriate.

Executing analytical test methods as part of PVP, when appropriate.

Author technical documents, validation and verification reports, study plans, risk assessments as well as root cause analysis memos and process/ product impact memos for major and minor deviations.

Data Analysis and Summary of upstream bioprocess data for Process Performance Qualification (PPQ) Batches (Commercial Manufacturing Scale).

Accomplishments:

Successfully executed Process Validation supporting, PPQ for a commercial lyophilized product, involving assessment of media biochemical stability and small scale bioreactor design validation for inter- site technology transfer.

Achieved target number of consistency runs for an improved second generation process for an existing commercial product, at a 500L bioreactor scale.

Graduate Laboratory Assistant 11/2015 to 07/2016

Engineering Research Center for Structured Organic Particulate Systems- New Brunswick, NJ

In charge of:

Data acquisition and multivariate modelling for NIR and Raman Spectroscopy for prediction and validation.

Material Characterization using FT4 Powder Rheometer and multivariate analysis.

Operating and Maintenance of tablet press used for the continuous manufacturing line at the pilot plant.

Preparation of samples using different lab scale blenders and feeders.

Assisting senior process engineers for improvements in existing continuous process line for solid dosage production.

Extensive interaction with vendors and on-site contractors to enable smooth executions of engineering tasks.

Analytical techniques like measurement of blend and content uniformity, tablet hardness, thickness, friability, and dissolution using HPLC.

Accomplishments:

Successfully produced stability and pilot batches of solid oral dosage forms using pharmaceutical unit operations like blending, compression, coating, drying and encapsulation.

Employed NIR and Raman Spectroscopy as in-line Process Analytical Techniques in terms of accuracy and ease of implementation for a project sponsored by FDA.

Built model for material characterization which aids prediction of feeder process parameters for the material, with minimum testing.

RESEARCH PROJECTS

NIR v/s Raman Spectroscopy as in-line process analytical Technique

Led study of efficacy of NIR and Raman Spectroscopy as in-line Process Analytical Techniques in terms of accuracy and ease of implementation in a in continuous manufacturing pilot plant for solid dosage forms.

Built prediction models [using CAMO UnScramblerX software ] for these techniques, for API percent monitoring in dry blends and tablets.

Aspirin Manufacture with Batch Reactor Optimization

In charge of a hybrid project involving manufacturing design and modelling of Aspirin API manufacture, as well as batch reactor optimization employing genetic algorithm.

Achieved successful optimization of real world manufacturing process with an increased product conversion of 93.8%.

Water purification by Bioremediation

Demonstrated effective water purification technique using activated fruit peels (treated banana and apple peels).

Analyzed the eco-friendly nature of the techniques by duplicating the results and conducting an oxygen demand study.

LEADERSHIP EXPERIENCE

Team Caption for Orange Day Events 09/2016 to present

Non- profit Initiative, GlaxoSmithKline, Rockville Site

Secretary 05/2013 to 05/2015

Indian Institute of Chemical Engineers (IIChE) Student Chapter

Hospitality Head 05/2012 to 05/2013

Indian Institute of Chemical Engineers (IIChE) Student Chapter

EDUCATION

Master of Science in Chemical and Biochemical Engineering (GPA-3.8) 09/2015 to 05/2017

Rutgers University - New Brunswick, NJ

Bachelor of Engineering in Chemical Engineering (GPA- 4.0) 05/2011 to 05/2015

Mumbai University, D. J Sanghvi College of Engineering - Mumbai, India

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