Job Title: Director of Product and Laboratory Development

Work Location: Harris County, Texas

Summary:

This position is responsible for product development of wellness, hospital, IV and other products in accordance with professional standards and practices established by the Company, Pharmacy, and regulatory best practices. You will be a senior management team member and as such participate in strategic and managerial issues including presentations and speaking engagements to assist sales and marketing teams.

Responsibilities:

• Develop new and enhance existing products.
• Assist with compliance with regulatory requirements following local, state, and federal laws regarding products.
• Regularly communicate with all staff and lead certain meetings.
• Coordinate sales and marketing with operations and monitor the customer experience as to product performance.
• Train the pharmacy team to new and improved products.
• Provide operating advice based on your knowledge and experience to others in Senior Management.
• Design stability studies, protocols for generating final reports, in conjunction with outside consulting firms.
• Evaluate, change, and test current formulas based on annualized product reviews, quality requests, or patient feedback.
• Review and help assemble Annual Product Reviews.
• Coordinate and assist with feasibility studies.
• Responsible for designing and performing different bench studies for Research & Development as needed.
• Technical writing and execution of qualification/verification protocols and summary reports for IQ/OQ and/or PQ of API suite, to name a few.
• Assist and contribute to the evaluation of non-conformances, exceptions, and/or deviations that could affect product safety and quality.
• Collaborate with vendors with project management for the purchasing of new materials and other items, including equipment.
• Participate regularly in continuous improvement training.
• Coordinate, in conjunction with a full turnkey start up by outside consulting firms, a 12-month Laboratory Readiness Program and oversee their progress.
• Responsible for overseeing licensing and attaining a fully licensed, independent laboratory in Houston, Texas.
• Provide updates as part of management as it relates to progress of New Product Development and Laboratory start up.
• Other responsibilities will be assigned from time to time.

Supervisory Responsibilities:

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; maintaining schedules, approving time off requests, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

• Ability to perform each essential duty satisfactorily.
• Knowledge, skill, and/or ability required as representative of the duties listed.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Published Category: Analytical & Process Development