Pavithra Premkumar
Madison
Summary
Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.
Overview
10
10
years of professional experience
Work History
Manager, Analytical Development
Catalent Pharma. Solutions
02.2022 - Current
- Manage phase III and commercial clients for mRNA drug substances
- Train and supervise team to develop bioanalytical assays (plate-based residual assays, sequencing for identity, capillary and LC based purity and integrity assays) following USP and ICH guidelines
- Engage in site audits by regulatory organizations (EMA, PMDA) for commercial authorization of biopharmaceutical products
- Perform cost and ROI analyses on various services provided by the analytical team within the company; advise on service pricing as needed
- Track deliverable timelines and report any shifts to site leadership and finance teams with justifications
- Supervise assigned team’s daily work activities including workload, ensuring training, general guidance to direct reports and across functional groups, and serve as resource for technical/ administrative problems
- Hire, train, motivate, lead, develop, and evaluate staff
- Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate and provide mentorship to other groups and clients as necessary
- Take corrective action as necessary on a timely basis and in accordance with company policy
- Ensure collaboration between Project Management, Product Development, and Quality departments and individuals is in accordance with performance expectations and Catalent’s values
- Review requests for proposals and scopes for accurate information, for both development activities and PD support analytics
- Support proposals and project management teams on custom analytical studies as requested by clients
- Ensure compliance with current federal, state, and local regulations
- Consult with Human Resources Department as appropriate
- Ensure maintenance of department laboratories and equipment, including 5S and environmental health and safety expectations, trouble shooting, qualification, and calibration, are supported
- Ensure target timelines to deliver results are met and data integrity
- Interact with customers during meetings; provide responses to customer’s questions
- Responsible for supervising the generation of records from platform programs and complex or atypical programs into reports
- Coordinate and execute the generation of client meeting presentations, analytical development and testing reports and/or batch production records to meet financial and project milestones
- Proactively supervise and/or respond to internal and client comments and work with scientists and SMEs to ensure data integrity is maintained and reports are consistent with GMP expectations
- Internal expert on batch production records content and analytical/development data; apply knowledge to design documents that contribute to the direction of the department
- Collaborate significantly to optimize documents and promote document unification with cross functional groups, including Project Management, Manufacturing, Manufacturing Science and Technology, Quality Assurance, Analytical Development, Quality Control, Cell Line Development, and Process Development
- Work to support the development of business strategies
- Ability to peer review data to ensure data is well-organized with complete documentation
- Good operating knowledge of lean principles, 5S, and inventory management systems to provide documentation oversight.
Associate Group Leader, Cell and Gene Therapy
PPD, Inc, Thermo Fisher Scientific
08.2020 - 02.2022
- Directly manage cGMP release and stability team of 15 FTEs
- Coordinate resources among multiple teams across various supervisors, and schedule activities in cGMP laboratory
- Review and approve quality events, deviations, investigations, and CAPA initiated and authored per internal SOPs
- Oversee daily operations of laboratory staff and ensure adherence to company policies, quality systems, and training programs
- Ensure client satisfaction by monitoring project progress, leading to project completion on promised timelines
- Perform line-level management, including interviewing potential candidates, and onboarding new department employees
- Conduct performance, annual bonus, and merit increase evaluations
- Create and establish sustenance and evaluation based on the 5S system at a new facility
- Perform annual inspections for BSL-1 and BSL-2 laboratories, per FDA guidelines
- Oversee appropriate cleaning and stocking of cellular and molecular suites per internal SOPs
- Establish a central department-wide consumables inventory to minimize the number of purchase requisitions placed
- Department point of contact for supply chain issues (consumable shortages, equipment back orders, etc.).
Senior Scientist, Cell and Gene Therapy
PPD, Inc, Thermo Fisher Scientific
02.2019 - 07.2020
- Technical lead for cell-based potency assay method development and qualification for gene and cell therapy products in a cGMP laboratory setting
- Testing analyst for other potency and infectivity methods within the Gene and Cell Therapy team
- Participate in validations and qualifications as an analyst, sample testing, mentoring junior analysts and training new analysts on client specific methods
- Develop and qualify cell-based potency assays for a gene and cell therapy product, adhering to FDA requirements and guidelines
- Responsible for project deliverables and timelines for timely FDA filings
- Perform troubleshooting, finance management, GMP method documentation, generating qualification/validation timeline, authoring deviations and investigations, data analysis, and report generation
- Train junior analysts on new assays, method development, and qualification/validation cGMP documentation requirements
- Participate in 5S sustenance activities to maintain lab cleanliness and organization.
Redox Biology Core Manager
Nathan Shock Center
07.2016 - 12.2018
- Responsible for junior analysts' orientation, training, and scheduling
- Perform and supervise complex laboratory analysis of various biological specimens in a GLP setting
- Draft tailored quotes for potential clients based on the specific assays requested
- Coordinate receiving, sample testing, data analysis, report generation and approval, and client communication on behalf of the core for various markers of oxidation (including protein and lipid peroxidation)
- Draft and deliver invoice to clients upon the completion of study; coordinate with finance department until invoices have been paid
- Responsible for running assays to assess mitochondrial function in cells using Seahorse XFe24
Senior Research Technician
OMRF
09.2014 - 06.2016
- Responsible for performing routine assays such as western blots and genotyping to help with all the ongoing projects in the laboratory
- Manage and maintain a large mouse colony of various genetically modified strains (Over 40 strains, colony size of over 1200 mice with 100 breeder pairs)
- Responsible for starting, maintaining and conducting experiments on primary fibroblasts and preadipocytes from the different genetic strains of mice
- Perform various drug dose response experiments on differentiated and stressed C2C12 myoblasts and myotubes
Education
Master of Science - Biomedical Genetics
Vellore Institute of Technology
Vellore, India08.2009
Bachelor of Science - Zoology
Stella Maris College
Chennai, India08.2007
Skills
- Program management
- People management
- Quality documents – QE, deviation, investigation, CAPA
- Continuous improvement - Lean six sigma yellow belt
- SOP drafting in Veeva and Documentum
- Development and validation of cellular and molecular assays per FDA requirements
- MRNA DS and DP life cycle
- Technical knowledge/ expertise - cell-based potency and infectivity assays, ELISA, qPCR, CE-LIF, Sanger sequencing, LC based integrity assays for mRNA DS, Seahorse Cell Mito stress test, SDS-PAGE, native PAGE for enzyme activity assays, western blot
- Team leadership
- Customer service
- Staff training and development
Timeline
Manager, Analytical Development
Catalent Pharma. Solutions
02.2022 - Current
Associate Group Leader, Cell and Gene Therapy
PPD, Inc, Thermo Fisher Scientific
08.2020 - 02.2022
Senior Scientist, Cell and Gene Therapy
PPD, Inc, Thermo Fisher Scientific
02.2019 - 07.2020
Redox Biology Core Manager
Nathan Shock Center
07.2016 - 12.2018
Senior Research Technician
OMRF
09.2014 - 06.2016
Master of Science - Biomedical Genetics
Vellore Institute of Technology
Bachelor of Science - Zoology
Stella Maris College
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