Cedent Consulting
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. #J-18808-Ljbffr
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. #J-18808-Ljbffr