Associate Director, Analytical R&D

Job Description
Under general guidance, designs, conducts and evaluates all analytical procedures for Analytical Research & Development (AR&D) during different phases of new product development; establishes specifications to assure safety and effectiveness is maintained on all new products.

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 management responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
.• Coordinates the activities of Product Evaluation, Stability, Methods Development and Validation to establish specifications for raw materials and finished dosage forms.
• Directs, reviews and validates analytical methods and procedures to assure that thefinished product meets safety requirements during all phases of New Product Development.
• Reviews and recommends approval of specifications, and evaluates products using accurate, specific and precise analytical measures to assure the validity of the data.
• Assures accurate and timely testing and reporting of all results; issues technical reports which include all certification and validation data.
• Assures that the assay, dissolution and stability testing is acceptable and sufficient; establishes specifications which assure that safety and effectiveness are maintained.
• Recommends approval of specifications for raw materials, in process, finished product and stability testing as necessary.
• Evaluates and monitors research lots and site qualification lots to assist in designing invitro product equivalence by using accurate, specific and precise analytical measurements to assure the validity of the data.
• Manages the preparation of CMC section of regulatory submissions, assures accuracy and validity of data submitted by assuring appropriate documentation and storage of original data, and that all information has been certified as to accuracy and validity.
• Performs related duties as assigned.

Qualifications
Required Knowledge and Skills:

Knowledge of:

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.• Pharmaceutical principles, practices and their application.

• Pharmaceutical and instrumental analyses and testing principles, techniques, applications and equipment.Project management principles and techniques.

• Current Company policies and procedures, including safety rules and regulations.

• English usage, spelling, grammar and punctuation.• Business and scientific computer systems and software applications.

Physical Requirements and Working Conditions: Requires the ability to sit, stand, walk,communicate via telephone, computer and/or face-to-face contact, vision to monitor, and usebasic office equipment such as a personal computer, copier and FAX machines. Traveling to conduct Company business is required. Work is performed in an office environment. Noise level in this environment may vary depending upon machinery usage.
Skill in:

Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),Pharmaceutical principles, practices and their application. Pharmaceutical and instrumental analyses and testing principles, techniques,Project management principles and techniques. Current Company policies and procedures, including safety rules and regulations.English usage, spelling, grammar and punctuation.Business and scientific computer systems and software applications.Planning, implementing goals, objectives and practices for effective, efficient and cost recommendations that support department goals and objectives.

Analyzing problems, projecting consequences of proposed actions, and implementing procedures and techniques.Researching, analyzing and evaluating new product development materials, methods,Communicating clearly and concisely, both orally and in writingManaging and organizing multiple projects and assignments.Establishing and maintaining effective working relationships with others.
Education
Minimum Qualifications:
Bachelors degree in a scientific/technical or related field from an accredited college or university, and eight (8) years pharmaceutical analytical chemistry experience, including two (2) years in a supervisory or management capacity, or an equivalent combination of education and experience.

Company

Actavis

Job Code

State or Province

Florida

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