Quality Control Manufacturing Associate

Nikita Gupta, BPT

Boston, MA *****

617-***-**** ***********@*****.***

Professional Profile

Results-driven manufacturing associate with extensive experience in bioprocessing, chromatography, and GMP-compliant manufacturing environments. Skilled in RNA production, IVT (in vitro transcription), dT chromatography, and buffer exchange with a strong focus on quality control and process optimization. Proficient in SOP development, inventory management, and training of personnel in biomanufacturing procedures. Recognized for strong problem-solving skills, compliance with regulatory standards, and ability to collaborate in fast-paced production environments.

Manufacturing Skills and Qualifications:

Automation Tools – Adept at using Hamilton Microlab STAR liquid handler and custom dT bots

Biomanufacturing Expertise – Hands-on experience in RNA synthesis, IVT, dT chromatography, and capping reactions

GMP and Quality Assurance – Experience in good manufacturing practice (GMP) environments, following aseptic techniques, and maintaining strict quality control

Automation and Equipment – Handling ultrafiltration bots, dT bots and Hamilton Microlab STAR liquid handler

Process Optimization and SOPs – Ability to develop and revise SOPs and bill of materials and ensure compliance with industry standards

Software Proficiency – Well-versed in Veeva, SAP, Blue Mountain, and custom laboratory management systems

Training and Leadership – Certified trainer for IVT and chromatography processes, mentoring new team members on best practices

Work Experience

MODERNA, Norwood, MA 07/2022 – 03/2025

Manufacturing Associate II (12/2023 – 03/2025)

Performed IVT (in vitro transcription) and dT chromatography for RNA production.

Conducted buffer exchange and concentration using advanced bioprocessing techniques.

Executed final product aliquot for quality control and inventory management.

Collaborated with the culture team in high-throughput operations.

Manufacturing Associate I (07/2022 – 12/2023)

Performed IVT, dT chromatography, and capping reactions for RNA synthesis.

Served as a qualified trainer for IVT and chromatography processes.

Created and revised standard operating procedures (SOPs) and bill of materials.

BRIGHAM AND WOMEN’S HOSPITAL, Boston, MA 08/2019 – 08/2021

Patient Care Associate

Provided clinical support in acute care, surgical preoperative, and postoperative units.

Assessed vital signs, performed glucose checks and EKGs, and assisted with ADLs.

Maintained accurate documentation in compliance with HIPAA regulations.

Trained and mentored new nursing students.

SPAULDING REHABILITATION HOSPITAL, Cambridge, MA 06/2017 – 09/2019

Patient Care Associate

Assisted ventilated patients in the pulmonary unit.

Performed EKGs, glucometer testing, and patient repositioning.

Documented patient care activities and responded to urgent call lights.

Utilized Epic software for medical documentation.

Professional Development

GMP and Aseptic Processing, Organization

RNA Manufacturing and Bioprocessing Techniques, Organization

Laboratory Safety and Compliance, Organization

Education

Bachelor of Physiotherapy (BPT), Area of Study, University / College, Meerut, India (2010)

Relevant courses included advanced anatomy and physiology, pharmacology, biochemistry, medical electronics and computer application, biophysics, biostatistics, biomechanics, clinical neurology, and general medicine and surgery.

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