Formulation Scientist

CEDENT

Largo, FL

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JOB DETAILS

SKILLS

Aerosols, Analysis Skills, Analytical Chemistry, Biotech and Pharmaceutical, Calibration, Chemistry, Communication Skills, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Satisfaction, Data Analysis, Data Entry, Documentation, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Infrared Spectroscopy, Internet Research, Leadership, Market Trend Analysis, Marketing, Marketing Presentation, Mentoring, Microsoft Access Database, Microsoft Excel, Microsoft Word, Multitasking, PC (Personal Computer) Systems, Peripheral Hardware, Personal Care, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Project Engineering, Project/Program Management, Quality Assurance, Quality Control, Record Keeping, Regulatory Compliance, Reporting Skills, Safety Process, Safety/Work Safety, Sales Presentation, Technical Presentation, Technical Research, Test Plan/Schedule, Vendor/Supplier Planning, Vendor/Supplier Relations

LOCATION

Largo, FL

POSTED

30+ days ago

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.

About the Company

CEDENT

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