Job Description

I&D Formulator III

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 include:

• Supporting efforts to brainstorm new customer concepts based on personal experience, market insights, competitive position, online research, technology/market trends, etc.
• Developing new products to meet customer requirements per assigned projects.
• Working to proactively prioritize multiple projects/workload, effectively anticipate/manage resource gaps, and deliver on agreed-to timelines.
• Developing new product ideas for presentation to Marketing for future consideration in customer innovation events.
• Preparing samples for customer evaluation or for use by Marketing, Project Management, Engineering, QC/QA.
• Actively assisting in the troubleshooting of off-target batches in the I&D Lab.
• Preparing protocols for both formal and informal stability testing.
• Accurately recording raw data and analyzing, as well as calculating and interpreting the results. Ensuring all documentation produced is in compliance with cGMP standards.
• Communicating effectively in verbal and written form on research results and plans.
• Demonstrating initiative in handling responsibilities.
• Attending project meetings and preparing project updates.
• Developing working relationships with vendors and attending vendor meetings.
• Maintaining raw material supply in I&D laboratory including but not limited to: vendor sample inventory, in-house sample inventory.
• Promoting cGMP and safety practices throughout the facility.
• Promoting continuous improvement and customer satisfaction.
• Recognizing OOS or out of trend results and assisting in the completion of lab investigations.
• Reading and understanding 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.
• Working to identify more efficient ways of working and shares ideas with management.
• Preparing and presenting technical presentations.
• Participating 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 overall lab safety, organization, cleanliness, calibration, and maintenance.
• Strong leadership and mentoring skills.
• Must be able to lift up to 15 pounds.

Preferred

• 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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