Director - Research and Development - 21st Century HealthCare - Phoenix

Job description
Director of Research & Development is responsible for new product development of dietary supplement products, preparing specifications, records, reports and pertinent FDA documentation as it relates. This position will establish, evaluate and improve product formulas, identify new product opportunities, address manufacturing issues and evaluate new and alternate raw materials. Director of R&D will create, review and rework Standard Operating Procedures (SOPs) and adhere to current Good Manufacturing Practices (cGMPs), while coordinating and tracking tasks involving analytical development, production, materials management, QC/QA and regulatory affairs.
Desired Skills and Experience
Essential Job Responsibilities – will include, but are not limited to:
Prepare specifications, documentation, and reports related to product development
Address quality, regulatory, and labeling issues for blends in bulk and finished products
Development of prototypes and/or production of trial samples, scientific review and specification of raw materials
Provide technical support to manufacturing including but not limited to process improvement, cost savings initiatives and trouble shooting
Create rework procedures

Evaluate alternate sources of raw materials
Serve as back-up contact for Director of Quality for any internal or external audits
Design and execute special projects
Grow with the company and lend personal skills and talents where and when they could benefit the position and the company
Manage in-process correction and troubleshooting process for tablets, capsules and soft chews
Manage the Master Batch Record creation & conversion process
Manage weekly production batch issuing process
Manage all Process Pro bill of material creation and maintenance for bulk formulations
Support and manage formulation related corrective action plans resulting from deviations and assume the approver for the Product Development department
Manage and conduct trial and pilot batch processing for new products and products being amended
Participate in label development, proofing, and correcting
Interact with QA & QC on formulation and process issues and investigations
Write, correct and review applicable SOPs
Research, review, qualify new ingredients both active and inactive
Specification correction and establishment for manufactured products
Improve current formulations that prove difficult to produce or that can have improvements made to enhance processing performance
Participate in and refinement of GMP and GLP activities as relating to the products and formulations
Work with operations to refine processing steps and procedures to gain consistency and to gain efficiencies
Participate in new product development with marketing
Participate on the cGMP committee

Education and Experience:
Bachelor’s degree preferred
3-5+ years in all or some of the areas of formulation/processing/documentation
Demonstrated knowledge of cGMP regulations
Practical computer skills – E-mail, Excel, Word etc. and the ability to learn new computer systems
Flexibility
Problem solving and investigational skills
Good communication

Knowledge and Skills:
Effectively exercises tact, discretion, judgment and diplomacy
Prioritizes demands on resources
Maintains high level of accuracy in all aspects of job function
Ensures strong sense of personal and professional ethics and character
Demonstrates strong analytical skills with ability to analyze and interpret data
Demonstrates strong computer skills
Maintains excellent oral, written, presentation and interpersonal communications skills
Team player with the ability to interface effectively with all levels of the organization; executives, staff, clients, outside agencies, organizations and individuals
Effectively works under pressure and meets tight deadlines
Handles detailed, complex concepts and problems, balances multiple tasks simultaneously, and makes rapid accurate decisions
Conveys a professional and positive image and attitude
Demonstrates commitment to continued professional growth and development

Competencies:
Quality Oriented
Integrity / Ethics
Teamwork
Decision Making / Judgment
Strategic Thinking

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