I & D Formulator III

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.

The specific statements shown in each section of this job description are not intended to be all-inclusive. They represent typical elements and criteria necessary to perform the job successfully. Formulated Solutions reserves the right to modify and expand job responsibilities and duties over time