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Formulation Scientist

Formulation Scientist

Formulated SolutionsLargo, FL, US
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Job Description

THE COMPANY :

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE :

The I&D Formulator III will have responsibilities for the design, development, testing and implementation of new formulations from initial concept through production; troubleshooting / resolving, adjusting or reformulating existing formulas as needed. This individual must have extensive cGMP experience and FDA and ICH Guidance experience. Must be able to provide leadership and mentoring to I&D Interns, Associates, and Formulator I(s).

MAJOR DUTIES AND RESPONSIBILITIES :

  • Supports efforts to brainstorm new customer concepts based on personal experience, market insights, competitive position, online research, technology / market trends, etc.
  • Develops new products to meet customer requirements per assigned projects.
  • Works to proactively prioritize multiple projects / workload, effectively anticipate / manage resource gaps, and deliver on agreed-to timelines.
  • Develops new product ideas for presentation to Marketing for future consideration in customer innovation events.
  • Prepares samples for customer evaluation or for use by Marketing, Project Management, Engineering, QC / QA.
  • Actively assists in the troubleshooting of off-target batches in the I&D Lab.
  • Prepares protocols for both formal and informal stability testing.
  • Accurately records raw data and analyzes, as well as calculates and interprets the results. Ensures all documentation produced is in compliance with cGMP standards.
  • Communicates effectively in verbal and written form on research results and plans.
  • Demonstrates initiative in handling responsibilities.
  • Attends project meetings and prepares project updates.
  • Develops working relationships with vendors and attends vendor meetings.
  • Maintains raw material supply in I&D laboratory including but not limited to : vendor sample inventory, in-house sample inventory.
  • Promotes cGMP and safety practices throughout the facility.
  • Promotes continuous improvement and customer satisfaction.
  • Recognizes OOS or out of trend results and assists in the completion of lab investigations.
  • Reads and understands SDSs for all raw materials they will be working with.
  • Responsible and accountable for compliance with all aspects of the company's Health and Safety policies, and Safe Work Procedures.
  • Works to identify more efficient ways of working and shares ideas with management.
  • Prepare and present technical presentations
  • Participates in other activities as assigned by the I&D Manager or VP of I&D.

QUALIFICATION : Required

  • Responsible for contributing to audit readiness and for assisting in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
  • Working knowledge of FDA regulation for drug / device especially for the lab.
  • Ability to use a personal computer and peripheral equipment to accurately enter an analyze data and produce reports.
  • Knowledge of chemical safety and personal protective equipment.
  • Proficient in approaches to aerosol and / or emulsion blending, chemistry and troubleshooting.
  • Advanced knowledge of various analytical equipment and techniques utilized in an analytical laboratory including but not limited to pH, viscosity, specific gravity, infrared spectroscopy, HPLC, GC, atomic absorption.
  • Demonstrated ability to represent the I&D technical function in cross functional team meetings.
  • Ability to establish priorities, work independently, productively and proceed with objectives without supervision.
  • Ability to handle and resolve recurring problems.
  • Communicates effectively in verbal and written form on projects and research results.
  • Ability to work in a dynamic fast paced-sometimes rapidly shifting environment and quickly establish priorities. Ability to concentrate in such an environment and perform quality work.
  • Contributes to for overall lab safety, organization, cleanliness, calibration, and maintenance.
  • Strong leadership and mentoring skills.
  • Must be able to lift up to 15 pounds.
  • Preferred Additional

  • Aerosol formulation experience strongly preferred.
  • Regulated products formulation experience strongly preferred.
  • CRITICAL SKILLS AND ABILITIES :

  • Advanced knowledge of benchtop and production scale emulsion chemistry
  • Familiarity with aerosol chemistry and delivery systems
  • Ability to independently generate formulas for experimental blending
  • Demonstrated ability to work both independently and in a team environment
  • COMPUTER SKILLS :

  • Familiarity with the use of MS Word, MS Excel, MS Access.
  • EDUCATION AND / OR TRAINING

  • Bachelor’s degree in Chemistry or appropriate discipline with 5+ years related experience in the personal care or pharmaceutical industry.
  • OR MS in Analytical Chemistry or equivalent with 3+ years related experience in a pharmaceutical industry a strong plus.
  • Environmental Demands

  • Exposure to chemicals and / or other potential hazards.
  • Exposure to loud noises.
  • Moving machines and robots.
  • Self-starting machinery.
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    Formulation Scientist • Largo, FL, US