Company Name: Actavis, Inc. Import
Job Details
Duration: Permanent
Min Education: Not Specified
Salary: Commensurate
Job Type: Full Time
Min Experience: Not Specified
Required Travel:
Location:
  • USA - Ft. Lauderdale Florida, 33301
Job Description
Description

Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Designs experimental plans; performs optimization work on Oral Controlled release and immediate release dosage forms. Generates and reviews analytical data to support the product optimization projects. Writes protocols and batch records to carry out process optimization and evaluation work, scale up and submissions to regulatory agencies. Plans appropriate analytical testing and stability studies on optimization batches. Performs appropriate documentation and prepares reports and other necessary documents to support regulatory filings. Surveys the scientific literature and performs patent search to remain current with recent developments in generic pharmaceutical research and regulatory arena and novel drug delivery systems. Maintains appropriate documentation of primary data records, protocols, reports and laboratory notebooks as required by Standard Operating Procedures. Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines. Provides scientific and technical directions to junior staff members (Scientists, Technicians & Operators) to ensure project deadlines and performance standards are met. Collaborates with supervisor to set priorities and reach objectives. Performs related duties as assigned.Qualifications

Required Knowledge and Skills : Knowledge of : Advanced knowledge of theories, practices and principles of physical pharmacy, pharmaceutics, pharmacokinetics, biopharmaceutics and statistical designs. Product formulations, product stability, packaging, and FDA submission, SUPAC Guidance and practices. Product design of controlled release dosage forms, working knowledge of multiparticulate systems, matrix systems, diffusion controlled and osmotically engineered pharmaceutical dosage forms. B usiness, scientific, statistical and personal computer hardware and software applications. Business English usage, spelling, grammar and punctuation. Leadership and training practices and methods. Current Company policies, practices and procedures, including safety rules and regulations. Skill in: Ability to efficiently handle pharmaceutical unit operations, such as fluid bed coater, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation and packaging. Leading the activities of technical personnel; making decisions and analyzing data. Leading investigations and determining root cause for product and product non-conformances. Performing statistical analyses including regression analysis, design of experiments and use of six sigma principles. Must have demonstrated skill in either Minitab or JMP statistical software. Communicating clearly and concisely, both orally and in writing. Operating scientific and personal computers. Managing multiple projects, duties and assignments. Coordinating and reviewing the work of assigned department personnel. Establishing and maintaining cooperative working relationships with others. Ensuring compliance with all Company policies and procedures, including safety rules and regulations. Physical Requirements and Working Conditions : Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, lifting materials and supplies weighing up to 30 pounds, vision to monitor, and moderate to loud noise levels. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Required to wear a respirator and be able to do physical work for extended periods.Education

Minimum Qualifications : Bachelor's Degree in Science or related scientific field from an accredited university, and eight (8) years related pharmaceutical experience or an equivalent combination of education and experience. Certified Six Sigma Black or Green Belt preferred.