Formulation Scientist III
24 days ago
Largo
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.