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business development lead project manager resume example with 8+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000 - Cell: - resumesample@example.com - : - -
Professional Summary

Versatile Pharmaceutical Professional successful at merging business innovation and technical management initiatives with fast-paced execution. More than 6 years in project leadership and project management with proven success in pharmaceutical, medical devices and OTC industries. Offers strong analytical, planning and organizational skills to manage competing demands.

Skills
  • Project and Team Leadership
  • Commercialization Strategy and Forecasting
  • Startup Culture experience
  • Proficient in MS Office - Word, Excel, Powerpoint, EndNote etc.
  • Proficient in MS Project and Smartsheets including Dashboard building
  • Critical Path Identification
  • Relationship building and management
  • Key decision making
  • New Business Development and Planning
  • Stability Data Interpretation and Trending Analysis
  • ICH/FDA/USP Guidance expertise
  • Quality by Design Methodology to Formulation Development
  • IVRT/IVPT Development/Validation and Interpretation by Franz Cell
  • Scale-Up Expertise and large scale trouble-shooting
  • ANDA Documentation writing and reviewing
  • Analytical Development and Validation Knowledge
  • Advanced Problem Solving
  • Project Planning And Development
  • Contract Review And Recommendations
Work History
12/2016 to Current
Business Development Lead/Project Manager Honda CO, State,
  • Communicated project plans and progress to key stakeholders, including project contributors, business, operational and technical resources.
  • Orchestrated projects within strict timeframes and budget constraints by solving complex problems and working closely with senior leaders.
  • Vetted potential contract contributors (e.g. Contract Manufacturers or Laboratories) to meet client's project goals.
  • Developed relationships with contributors to supply chain such as vendors, manufacturers, contract laboratories etc.
  • Prepared and edited RFPs, Proposals, technical documents and partnership documents including but not limited to: regulatory documents for ANDA, NDA, Medical Devices, partnership contracts etc.
12/2016 to 12/2018
Associate Director, R&D and Commercialization Intel Corp. Hudson, MA,
  • Lead the efforts of a team of 5-8 members in formulation development, technology transfers, stability data interpretation and commercial planning.
  • Developed timelines, budgets, FTE requirements and training programs for fast program execution and team development.
  • Identified the critical paths to project success through the use of cross functional discussions and software analysis.
  • Strategized about regulatory pathways and heavily involved in ANDA Documentation Writing and Review process.
  • Implemented new processes and software to streamline document flow, project management efforts and improve overall communication efforts in a startup environment.
12/2015 to 12/2016
Project Leader Solaris Pharma Corporation City, STATE,
  • Conducted formulation development, technology transfers and FDA-related response efforts along with team members.
  • Led reverse-engineering activities for Q1/Q2 bio-waivers, analytical method development and validation of Assay, Related Compounds and Alcohol methods
  • Formulated robust products for ANDA filings through Design of Experiments and Scale-Up Activities for topical Rx semi-solids, solutions and foam products.
  • Performed extensive ANDA Documentation writing and review for regulatory submissions.
  • Took on responsibility for Project Leadership, team management, mentoring experience through hands-on training and process streamlining in a startup environment.
06/2012 to 12/2015
Research Scientist DermPathe Pharmaceuticals LLC City, STATE,
  • Performed study design, execution and report writeups for formulation and analytical development efforts for different clients.
  • Participated in regulatory discussions with clients to ensure proper strategy for development including conducting background literature searches on Products through Patent landscaping, FDA guidance review etc.
  • Developed and validated in-vitro Release and Permeation testing via Franz-type Diffusion systems for both biowaiver and clinical based products.
  • Formulated robust products by understanding Quality Target Product Profiles and using Design of Experiments (DoE) methodology to mitigate Product risks.
  • Performed Technology Transfer experience in both analytical methods for validation and formulation process for scale-up of ointments, creams, and solutions.
Education
Expected in 05/2018 to to
Bachelor of Arts: Biological Sciences
The State University of New Jersey - New Brunswick, New Jersey
GPA:
Expected in 12/2020 to to
MBA: Innovation And Entrepreneurship
The University of Texas At Dallas - Richardson, TX
GPA:
  • Graduated with 3.8 GPA
  • Member of Dean's Council
Expected in 12/2020 to to
Master of Science: Innovation And Entrepreneurship
The University of Texas At Dallas - Richardson, TX
GPA:

Concentration: Innovation Within Corporation

  • Graduated with 3.8 GPA

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Resume Overview

School Attended

  • The State University of New Jersey
  • The University of Texas At Dallas
  • The University of Texas At Dallas

Job Titles Held:

  • Business Development Lead/Project Manager
  • Associate Director, R&D and Commercialization
  • Project Leader
  • Research Scientist

Degrees

  • Bachelor of Arts
  • MBA
  • Master of Science

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