Director of Manufacturing & Plant Operations Aprecia Pharmaceuticals
THIS JOB HAS EXPIRED Job ID18
OverviewThis position is responsible for leading all site activities including but not limited to manufacturing, engineering, facility, compliance, scheduling, material handling and human resources.
Description of Duties?Lead and manage all cGMP manufacturing to meet compliance demands of Quality, Regulatory, Testing, Validation and Marketing of pharmaceutical products.
?High degree of knowledge of cGMP Operational requirements and experience writing, editing, reviewing and operating within pharmaceutical compliance.
?Thorough understanding of government regulations including FDA, EPA, DEA, OSHA, etc.
?Ensure that all personnel are sufficiently skilled and trained to perform their functions in a high-quality and efficient manner.
?Ensure a safe working environment at all times.
?Coordinate all material ordering, handling, and flow.
?Coordinate Engineering, Maintenance, Financial and Manufacturing to ensure facilities and equipment are properly maintained and that company property is well managed and audited.
?Create environment of cooperation among R&D, Manufacturing and Engineering to accomplish the goals of the company while maintaining the highest quality.
?Heavy involvement in regulatory submissions.
?Manage and prepare manufacturing operations and facility for PAI inspection and other cGMP inspections.
?Establish daily methods of communications with manufacturing teams.
?Ability to represent plant functions and manufacturing to regulatory agencies.
?Coordinate and manage all facility construction.
?Establish quarterly budgets and timelines.
Minimum Requirements?A BS/MS degree in a related discipline.
?A minimum of fifteen (15) years of experience in the pharmaceutical industry and at least half of which was spent in management of people and manufacturing operations.
?Excellent oral and written communications skills.
?Expert knowledge of cGMPs and FDA pharmaceutical regulations.
?Well-developed interpersonal and problem solving skills.
?Excellent leadership and organizational skills.
?Experience in dealing with Regulatory Agencies
State/ProvinceNew Jersey NJ
Amount of Travel25%
||East Windsor, NJ |
THIS JOB HAS EXPIRED