Nikita Patil
Apex,NC
Summary
Experienced Principal Manufacturing Specialist at KBI Biopharma specializing in GMP compliance and CAPA management. Achievements include significant enhancements in manufacturing efficiency through process innovation and leadership. Proficient in chromatography and regulatory documentation, adept at managing complex projects and developing team capabilities.
Overview
13
13
years of professional experience
Work History
Principal Manufacturing Specialist
KBI Biopharma
07.2024 - Current
- Implemented new processes and equipment to enhance GMP manufacturing efficiency.
- Assessed GMP discrepancies, resolving issues through CAPAs and process improvements.
- Reviewed and approved critical manufacturing documents, including batch records and SOPs.
- Approved protocols and reports for PPQ campaigns, ensuring compliance with regulations.
- Managed department workload by delegating tasks among team members effectively.
- Acted as Change Owner for commercial projects, reviewing necessary deviations for approval.
- Tracked manufacturing documents for Downstream operations to maintain manufacturing schedule
Manufacturing Supervisor Specialist
KBI Biopharma
07.2021 - 06.2024
- Managed daily operations and evaluated direct reports through hiring, training, and development processes.
- Approved documents drafted by team members, offering constructive feedback on deviations and CAPAs.
- Handled generation of change controls for commercial records while overseeing departmental CAPAs for PAI audits.
- Actively represented department in client meetings, negotiating favorable outcomes with clients.
Technical Writer III
KBI Biopharma
12.2020 - 06.2021
- Tracked review and approval progress of production records to ensure timely completion.
- Trained new team members on processes and standards for accuracy in production records.
- Resolved client comments on production records to enhance satisfaction and clarity.
Manufacturing Technical Writer
KBI Biopharma
03.2018 - 12.2020
- Created batch records, solution records, and BOM in Great Plains and ASCTrac.
- Acted as SME for buffer preparation and tech transfer processes.
- Managed CAPAs and change controls to ensure compliance with regulatory standards.
Technical Writer
Pharmaceutical Company
06.2016 - 10.2017
- Created batch manufacturing records, BOM, and validation protocols.
- Managed deviations, CAPAs, and change controls using QAMS tool.
Regulatory Affairs Executive
ELC Group
07.2012 - 07.2014
- Submitted MA applications to regulatory authorities for European countries, adhering to guidelines similar to US FDA standards.
- Provided technical support in document preparation and editing for MA submissions, including eCTD and paper formats.
- Reviewed and edited technical documents, identifying deficiencies to compile comprehensive deficiency reports.
- Managed life cycle of regulatory dossiers, ensuring timely post-approval maintenance submissions.
- Prepared and submitted variation packages, including renewals of MA applications.
- Published eCTD using Knowledge Net Software while ensuring compliance with submission timelines.
- Responded to agency queries during registration assessments, maintaining adherence to submission schedules.
- Conducted quality checks on all documents and prepared MSDS and REACH dossiers for various chemicals.
Education
Master of Pharmacy - Pharmaceutical Chemistry
Gujarat Technological University
Ahmedabad01.2012
Bachelor of Pharmacy -
Veer Narmad South Gujarat University
Salvav01.2010
Skills
- GMP manufacturing and compliance
- Technology Transfer Process
- Chromatography expertise
- AKTA systems and Unicorn software
- Viral inactivation and filtration
- Ultrafiltration and diafiltration
- CAPA management and deviation investigations
- Regulatory documentation and submissions
- Leadership and team development
Laboratory
- Laboratory experience performing TLC, CC to carry out various chemical reactions includes weighing, pipetting, dilution, cleaning of equipment, and purification process.
- Hands-on carrying out different tests for tablets like dissolution test, disintegration test, weight variation, hardness, and thickness of the tablet.
Training
- Intro to Human Factoring & Human Factoring of Records, Pathwise, 2020
- How to Write SOP’s for Human Error Reduction, GRC Educator, 2023
- People Manager Course, Franklin Covey, 2023
Regulatory
- Providing regulatory advice and strategy regard to the acceptability of submission documents
- Filing regulatory applications and response to the agency in accordance with per predetermined timelines
Administration And Leadership
- Identifying needs and assembling a team to initiate, track and implement process improvements
- Responsible for on-the-job training for new employees for the buffer preparation
- Acting as the most senior/experienced member to lead a small team
- Responsible to ensure the department is trained on proper procedures
- Prioritizing individual workload with fast paced environment
- Provide input into the implementation strategy of various initiatives
- Interviewing and hiring of new team members
- Goal settings and tracking for myself, trainee and direct reports
- Prioritizing completing demands and managing my own workload
Timeline
Principal Manufacturing Specialist
KBI Biopharma
07.2024 - Current
Manufacturing Supervisor Specialist
KBI Biopharma
07.2021 - 06.2024
Technical Writer III
KBI Biopharma
12.2020 - 06.2021
Manufacturing Technical Writer
KBI Biopharma
03.2018 - 12.2020
Technical Writer
Pharmaceutical Company
06.2016 - 10.2017
Regulatory Affairs Executive
ELC Group
07.2012 - 07.2014
Master of Pharmacy - Pharmaceutical Chemistry
Gujarat Technological University
Bachelor of Pharmacy -
Veer Narmad South Gujarat University