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Sr. Project Manager Resume

Somerville New, JerseY

SUMMARY

Aggressive resourceful, Take - Charge Senior Program Manager with comprehensive skills in the administration and day-to-day supervision of technical and support systems. Responsible for the monitoring and execution of both Drug development and Medical Device projects including MS Project timeline, budgets, quotations and scope changes.

TECHNICAL SKILLS

  • Pharmaceutical Development Project Management
  • First to File Project Management
  • Solid Dosage delivery system experience
  • Soft gel delivery system experience
  • Class 1 Medical Devices
  • DEA Control Substances (Schedule 1 & 3) cGMP environment
  • Quality Assurance
  • Regulatory Compliance
  • Process Validation and Verification
  • Product Introduction
  • Scheduling and Planning

PROFESSIONAL EXPERIENCE

Confidential, Somerville, New Jersey

Sr. Project Manager

Responsibilities:

  • Build and managed 1,600 + line MS project schedule
  • Lead cross-functional development meeting to insure project goals are on schedule
  • Set up meeting agendas, lead meetings, issued meeting minutes and followed up team assignments
  • Set-up and held regular bi-weekly meeting with 14 separate operational groups
  • Updated schedule based on completion or delays in tasks
  • Issued Critical Path timeline, including 2-week, 4-week and 2-month Look Ahead reports

Confidential, Princeton, New Jersey

Sr. Project Manager

Responsibilities:

  • Generated MS Project timeline for the 5-Modules needed for NDA filing of new drug.
  • Responsible for maintaining meeting minutes and action items.
  • Issued Risk Assessments in all phases of project
  • Acted as conflict resolution mediator
  • Currently working with 31 outside contract teams and internal Sun team.

Confidential, Somerset, New Jersey

Sr. Project Manager

Responsibilities:

  • Manager multi-discipline cross-functional teams, from project inception to technical transfer to production.
  • Issued monthly project reports to management team included project delays, resource and budget issues.
  • Controlled conflict resolution issues within functional groups
  • Prepare project proposals and quotations including preliminary timelime, funding limitations, procedures for accomplishing project, staffing requirements for internal Catalent programs.
  • Develop strategic planning and aggregate project scheduling for timely completion of customer projects
  • Maintain project revenues to ensure timely completion of project tasks
  • Develop project timelines on twelve current projects, with revenue of $130K - $2.0MM per project
  • Lead teams in the launch of Commercial products including Vivus Qsymia Beads in Hard Shell Capsule, J&J’s Monistat-3, K-Y LiquiBead (Value $4,000,000/year), Insys Generic Marinol softgel capsules (Value $9,000,000/year) and Actavis First to File (Ethyl Icosapentate Softgels)
  • Main contact with customer both internal and external, setup and conduct weekly update meeting on all active projects.
  • Responsible for maintaining meeting minutes and action items

Confidential, Princeton, New Jersey

Program Manager

Responsibilities:

  • Created and wrote SOP’s, DMR (Device Master Record), DHF (Device History File), Risk Analysis, Gap Analysis and FDA filing with regulatory and compliance group regarding medical devices regulations.
  • Sited, audited and validated outside contract manufacturing for medical device product production.
  • Voting member on the United States delegation to, AAMI (Association for the Advancement of Medical Instrumentation), ANNA (American Nephrology Nurses Association), ANSI (American National Standards Institute), and ISO (International Standard Institute) for standards development as adopted by USP (United States Pharmacopeia).
  • Editor of group of 18 writing Hemodialysis international standards.
  • Represented Confidential & Confidential at NAGC (National Association of Gas Chlorinators) national and local meetings.
  • Directed both medical and non-medical product development including, Hemodialysis products, Commercial and Professional product lines, Microdermabrasion products and Ostomy deodorizer’s products.
  • Supervised all technical aspects for sodium bicarbonate in the dialysis, pool and spa industry.
  • Implemented the training of 5 laboratory associates in generating technical data to maintain Confidential & Dwight’s 95% US market share for dialysis bicarbonate.
  • Formulated new pool chemicals including “Clear Balance” tablets and granular material for the control of pool water’s alkalinity and pH. U.S. Patent granted.
  • Devised innovative delivery systems for chemical formulations use in residential and commercial pools.
  • Set-up in-house and field pool studies, including stabilize studies and consumer test panels.
  • Design field study protocol for sodium bicarbonate pool products for patent and marketing claims.
  • Accountable all technical requirements for sodium bicarbonate additives for food group specializing in new levening technology.
  • Major customers include General Foods, Confidential and Confidential Foods.
  • Traveled worldwide as technical representative for dialysis programs.
  • Represent Confidential & Confidential at technical and trade shows in the dialysis industry.
  • Develop custom sodium bicarbonate granulation cuts for revolutionary dialysis delivery systems.

Confidential, Cranbury, New Jersey

Senior Research Scientist

Responsibilities:

  • Formulation of Shampoos, Conditioners, Baby Care products, Moisturizing Lotions, Hand and Body Lotions, Sun Blocks, Styling Gel and, Polyvinyl Masks.
  • Four years’ experience with emulsion formulations and stability studies.
  • Designed and developed process lines for production operations.
  • Daily tech service contact with customers, delivering production ready formulations

Confidential

Senior Research Scientist

Responsibilities:
  • Formulations included liquid hand dish detergent
  • Liquid laundry detergent and powder detergents formulations. Including reformulation of current granular laundry detergent without APE’s.
  • Developed granulation viability for surfactant blends.
  • Confidential was in charge of purchasing pilot plant equipment for wash lab including Witte Fluid Bed dryers, single screw doom extruders, granulating equipment, and process milling units.
  • Formulation of spray dried adjuvants, WDG’s, EC, SC, WP, Aqueous and Non-aqueous suspensions, as well as manufacturing process technology both at pilot plant and production levels.

Confidential, Passaic, New Jersey

Plant Manager

Responsibilities:

  • Accountable for customer contact and sales.
  • Conducted research and development in the production of semi-solids and solid dose products.
  • Conducted research and development in the production of liquid and semi-solid surfactants for the cosmetic industry, as well as general household cleaners sold under the Confidential label.
  • Manufactured all creams, and lotions, shampoos and cleaning products.
  • Purchased equipment and chemicals and sourcing of new vendors.

Confidential

Chief Assay Chemist

Responsibilities:

  • Supervised precious metal refining facility operations.
  • Developed and implemented daily water testing method, and monthly soil testing.
  • Designed and installed air pollution equipment to meet California EPA, and federal regulatory agencies for the reduction of air pollution from smelting operation.

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