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Pratima Mehta email Id: pratima.b.doshi@gmail.

com
Contact No.: +91-9890297581

SUMMARY
 10 years of overall Biopharmaceutical experience
 2+ years of experience as a Project Manager majorly in Biopharma with focus on:
 Eliciting, gathering, analyzing, and communicating requirements
 Liaisoing with stakeholders, team members & vendors
 Plan, prioritize, execute & deliver different parts of a project
 Formulation & set-up of internal systems of a startup
 5 years of experience as a Freelance Content Writer
 Experience in content development & management
 Experience in writing & editing for various fields- health, e-learning, solar energy, real estate, cloud technology
 Knowledge of social media management
 Experience working in e-Learning for Biopharma & non-Biopharma (education, food, services) sectors
 Experience working collaboratively as well as an individual contributor

COMPETENCIES

Project Management
 Genuine team player committed to delivering end to end integrated projects.
 Handling project management flawlessly while contributing to others departments too.
 Cross-functional communicator easily interfaces with staff across the hierarchy, vendors, and customers.
 Versatile & innovative professional with scientific educational background.
 Involved in planning phases - schedule, budget, scope and risk; and then execution activities.
 Accountable for delivery and realization of projects.

Quality Management
 Development of Validation Protocol for Equipment, Utilities and Facilities as per VMP, URS, DS, DQ, IQ, OQ, PQ
 Monitoring and effective implementation of cGMP and QMS tools like Change control, CAPA, Deviation, Risk assessment.
 Monitoring document control management.

Pharma Engineering/Qualifications
 Review and finalization of qualification protocols.
 Responsibilities included reviewing and approving design documents, execution and documentation of qualifications of
Clean Utilities, Facility and HVAC system, Process Equipment and warehouse.
 Knowledge of guidelines & requirements

WORK EXPERIENCE
 Ufirst Neutrabiotic Private Limited from March 2019 to April 2020
 KA-inos Healthcare Private Limited from Feb 2016 to April 2017
 Emmersive Infotech Private Limited from July 2015 to Feb 2016
 Vita Scientia Globus Private Limited from Sep 2014 to Feb 2016
 Scigen Biopharma Private Limited from Jan 2010 to Aug 2014

EDUCATIONAL QUALIFICATION
 Masters – MSc. Biotechnology, Nirma University, Ahmedabad (Nirma University)
 Bachelors – BSc. Biotechnology, Vidya Pratisthan’s School of Biotechnology (Savitribai Phule Pune University)
 HSC – M.E.S Abasaheb Garware College, Pune (Savitribai Phule Pune University)
 SSC – St. Helena’s School, Pune (ICSE Board)

PROFESSIONAL EXPERIENCE

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Pratima Tejas Mehta email: pratima.b.doshi@gmail.com
Contact No.: +91-9890297581

Ufirst Neutrabiotic Private Limited Duration: 1 year 1 month


Role: Program Head
 Focus on biopharmaceutical, & FMCG verticals
 Formulation & set-up of internal systems of the startup
 Building project charters, project plans & pitch decks – draft, identification of needs, scope of scalability, goal-setting,
timeline setting & management
 Licenses & regulatory requirements for food & biopharma – FSSAI, FDA, CDSCO
 Managing inter-departmental activities – HR, Finance & Purchase
 Drive and liaison with teams – promotion & branding & marketing & sales team
 Explore funding options, preparation of pitch, presentations and pursual of finance options for projects
 Management of statutory, regulatory and legal requirements & demands of the organization
 Liaisoing with third-parties – for CS, CA, Trademark, and Patent related activities
 Management of project schedule and resources
 Responsible for the efficient management of all associated tasks and perform project management functions to include
the Initiating, Planning, Executing, Monitor and Controlling, and Closing of all projects

KA-inos Healthcare Private Limited Duration: 1 year 2 months


Role: Project Manager
 Product Portfolio – Biosimilars (Recombinant Enzymes)
 Execute and implement the business road-map of organization along with inter-departmental team members
 Project portfolio management and feasibility analysis
 Explore funding options, preparation of pitch, presentations and pursual of finance options for projects
 Management of statutory, regulatory and legal requirements & demands of the organization

Emmersive Infotech Private Limited Duration: 7 months


Role: Project Manager - Content
 E-learning content development & review
 Liaisoning with client company for understanding requirements & deliverables for modules, LMS & training (cGMP & data
integrity modules)
 Knowledge of storyboarding, instructional designing, tools for e-learning
 E-learning blogs for company website & platforms
 Handling of social media pages of the company- Facebook, LinkedIn
 Development & review of content across company’s plans – newsletters, brochures, flyers, website
 Inputs for UI & UX for development of company product website

Vita Scientia Globus Private Limited Duration: 1 year 6 months


Role: Quality & Validation – Executive
 Was a core team member on facility qualification and validation in providing Consulting Quality support to the project for
commissioning of a state of the art facility for manufacturing of rHuman Insulin API – URS, DQ, IQ & PQ documents
 Responsibilities included reviewing and approving design documents and documentation of qualifications of Clean
Utilities, Facility and HVAC system, and Process Equipment
 Third party support in making Quality Related SOP's and validation protocols

Scigen Biopharma Private Limited Duration: 4 years 6 months


Role: Executive- Quality Control (Molecular Biology)
 Handling key aspects of quality control of product w.r.t molecular biology. Testing quality of products as per specification
by molecular biology protocols.
 Adept at designing, review, execution and documenting different analytical experiments related to yield optimization and
scale up.
 Have hands on experience in preparation of SOPs, Validation Protocols, Qualification protocols as per current GMP and
GDP.
 Analysis of in-process and finished product of Human Insulin, Human Granulocyte Colony Stimulating Factor (GCSF) and
Carboxypeptidase B (CPB).

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Pratima Tejas Mehta email: pratima.b.doshi@gmail.com
Contact No.: +91-9890297581

 Cross-functional support in analysis of raw materials, vendor qualification and PQ of process water, purified water, water
for injection (WFI) and effluent treated water.
 Planning and implementation of cGMP compliant quality systems in molecular and immunology department.

TRAINING
 Project Management: The Basics for Success
 Science of Exercise
 Prescription Drug Regulation, Cost & Access: Current Controversies in Context

OTHER ACTIVITIES & INTEREST


 Volunteer member of Cipla Palliative Care & Training Centre, Warje, Pune
 Technical reader for visually impaired person
 Personal blog at www.mindofmine.co.in
 Interest in Art forms, Running, Writing, Reading, Community Welfare & Hiking

RECOGNITION
 Published writer at www.wrisources.com (https://bit.ly/3ccqVCt) & www.wellthyfit.com (https://bit.ly/2WuX41E)

PERSONAL DETAILS
 Birth Date: 14 July 1986  Marital Status: Married
 Current Residence: Chinchwad, Pune, Maharashtra  Nationality: Indian

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