Project Manager Process Development

SWATHI CHIVUKULA, M.S.

720-***-**** • ******************@*****.***

***, ******** ****, ****, ********-80516

EDUCATION

August 2014 – May 2017

Masters in Bioengineering

GPA: 3.7/4

Department of Bioengineering, University of Colorado, Anschutz Medical Campus, CO, United States

June 2006 – May 2011

Integrated master’s in industrial biotechnology (Engineering)

GPA: 3.8/4

SASTRA University, Tamil Nadu, India

SKILLS

Experience transitioning new products through process development gates and milestones in a regulated environment for medical devices development and manufacturing.

Capable of strategizing techniques for streamlined risk management and yield improvement

Knowledge concerning process maturation from lab-based procedures to fully automated continuous-mechanical-assembly (CMA)

Proven skills with respect to equipment qualifications and succinct IQ, OQ, PQ documentation

Expertise in biological reagent handling (e.g., antibodies, recombinant proteins) and lyophilization

Ability to translate design requirements into functional production equipment and or process by defining, designing and/or communicating efficiently

Skilled in authoring manufacturing Standard Operating Procedures (SOPs) and detailed work instructions

Expertise in Design of Experiment for novel equipment and or process development

Expertise in sterile technique, molecular and chemical analytical techniques

Experience in design and testing of tools and methods for process improvements

Leadership and training experience along with exceptional vendor management skills

Excellent verbal and written communication skills

EXPERIENCE

Senior Device Development Engineer (Remote)

Colossal Biosciences, Dallas, TX

September 2022- Present

Lead device development engineer responsible for the development of a novel embryo development device with scope for large scale development.

Successfully collaborated with cross-functional teams to identify a list of requirements and overall scope for the prototype design and development.

Contributed as a lead towards several prototype designs to help understand the true boundary conditions of the process and the final device.

Took ownership of streamlining the documentation practices of the multi-faceted team to bring in intentional design of experiments, resource management and effective communication.

Identified several unique and targeted equipment needed to make effective and reproducible measurements and to reach timelines, successfully.

Utilized program management tools such as Jira, Notion, Smartsheets for effective collaboration, remotely. Utilized tools such as Elabs and Microsoft Suite for documentation.

Process Engineer – Process Development

LightDeck Diagnostics Inc, Boulder, CO

August 2021 – September 2022

Contributed as a major technical expert towards a BARDA grant which facilitated scale-up of in-vitro diagnostics product by 40 times.

Completed the execution of the scale-up project though successful management of automation and scale-up project of an important process in manufacturing and operations within the stringent project timelines.

oResponsible for initiating and supporting multiple suppliers that contribute towards our automated and semi-automated lines, both as a technical expert and project manager.

Responsible for equipment and process validation of equipment in the scale-up project.

Worked on design and testing of prototypes contributing to improvement of automated and semi-automated lines, proactively.

Successfully transitioned towards new, safer and more robust equipment to while satisfying process requirements through meticulous testing, consulting and evaluating with EHS and by providing new interactive trainings to operators.

Research Associate II – Process Development

LightDeck Diagnostics Inc, Boulder, CO

October 2020 – August 2021

Functioned as process owner/SME for a key component in product manufacturing line and development.

oWas responsible for equipment and process validation and continuous improvement in alignment with medical device regulatory requirements.

oResponsible for characterizing processes and technologies for optimal manufacturing throughout

Functioned as a point of contact between R&D /molecular assay development and manufacturing teams and facilitate day-to-day manufacturing support through troubleshooting, training and coordination efforts.

Interfaced with several leading automation companies to facilitate rapid scale-up of current manufacturing process.

Research Associate – Assay and Engineering

MBio Diagnostics Inc, Boulder, CO

June 2018 – May 2019

Developed molecular (anti-body based) diagnostic assays, upon microarray based planar waveguides for effective disease diagnosis, in alignment with MBio’s patented LightDeck® technology, a powerful fluorescence assay illumination and imaging system.

Developed and optimized experimental engineering methods to test products and prototypes to improve the efficacy and applicability of the MBio platform.

Led cross-functional team collaboration with RedBud labs, NC and opened up the possibility of increasing the signal amplification of the MBio platform by two times.

Worked as a team on multiple projects simultaneously to develop and optimize protein/biomarker based molecular assays in a regulated environment using GLP.

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Professional Research Assistant

Department of Bioengineering, University of Colorado, Anschutz Medical Campus, CO, United States

September 2017 – May 2018

Evaluated biocontamination and quality of reprocessed single-use, vessel sealing, electro-cautery devices from Surgical Innovations (SI), Medtronic, Boulder, CO, post standardized sterilization.

Contributed towards technical planning and development of a large scale, standardized test protocol in collaboration with R&D, regulatory and marketing teams from SI, Medtronic, Boulder, CO.

Led the execution of quality assessment techniques for identification of protein and DNA using confocal microscopy and luminol photography, to identify hemoglobin contamination.

Research Assistant

Glenn Furuta lab, Mucosal Inflammation Program, University of Colorado, Anschutz Medical Campus, Research Building-2, Aurora, CO

September 2016 - May 2017

Innovated upon the development, execution and validation of a novel in-vitro model of Gastro-Esophageal Reflux Disease (GERD), that produced a specific protein truncation, previously established as a biomarker of GERD.

Tested the applicability of Enterotracker™, a novel minimally invasive device, toward monitoring of GERD, upon the above-mentioned in-vitro model.

Mastered aseptic techniques and molecular analytic techniques such as cell culture, protein and MRNA handling, RT-PCR, Western blotting, densitometry and statistical data analysis (Prism, Excel).

Documented the experimental method for producing the biological biomarker of GERD and, testing Enterotracker™ as a potential diagnostic device for GERD, for further studies in the form of a scientific thesis.

Defended the findings to an inter-disciplinary team of mentors and experts for evaluation.

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