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Formulation Scientist

Cedent Life Talent

I&D Formulator IIIThe 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: RequiredResponsible 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.PreferredAerosol 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.

Vacancy posted 5 days ago
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