Senior Scientist - (Physical Pharmacy Characterization)
Watson Pharmaceuticals - North Brunswick, NJ

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Summary :
                                              Under limited supervision, participates as a team member in method development and validation and complex technical investigation efforts, performs highly technical and specialized Analytical Scientist duties, research on assigned problems and studies in support of Watson’s efforts. Sr. Scientist additionally provides lead duties by providing technical assistance and training. 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.
                                              · May supervise, coordinate, prioritize and lead the daily activities of a group of Analytical Scientists and schedule their workloads.
                                              · Designs experimental plans; researches and critically analyzes data and information gathered in support of project directives. Performs and may oversee the development and validation of Physical Characterization methods for testing raw materials, IP, FP and ST sample testing such as XRD, Raman spectroscopy, FTIR, NIR, DSC, TGA, microscopy, SEM, surface area, PSD by Laser Diffraction; drug substances and drug dosage forms.
                                              · Responsible to oversee the performance of accelerated and room temperature stability studies for new products (experimental and site qualification lots) as well as the evaluation of stability data and the submission of stability data required for ANDA submission.
                                              · Oversees the analysis of Analysis of competitor products, drug substances, excipients, and experimental products to provide information for Product Development, the dissolution testing of Company and competitor products, the physical characterization of drug substances, excipients and dosage forms.
                                              · Maintains appropriate documentation of records, report sheets and laboratory notebooks as required by Standard Operating Procedures (SOPs).
                                              · Cleans, maintains and calibrates laboratory equipment and work areas to ensure compliance with SOPs, current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMPs).
                                              · Provides scientific and technical leadership to junior staff members to ensure project deadlines and performance standards are met. Collaborates closely with Supervisor to set priorities and reach objectives.
                                              · Performs appropriate administrative functions to assure compliance with government regulations, GMPs, and company policies.
                                              · Surveys the scientific literature to remain current with developments in analytical chemistry, pharmaceutics, pharmaceutical testing, and adds technical competence.
                                              · Prepares and presents written and oral reports on research findings, project status, literature reviews, and technical issues that affect Company’s business.
                                              · Provides formal and informal training to research staff on technical subjects, administrative procedures, and regulatory requirements.
                                              · Selects, justifies, and implements appropriate instrumentation, computer programs, and procedures to achieve product development support objectives.
                                              · Ensures compliance with all Company policies and procedures, including safety rules and regulations.
                                              · Performs related duties as assigned.
                                              Qualifications
                                              Required Knowledge and Skills :
                                              Knowledge of : · Pertinent SOP laws related to pharmaceutical laboratory testing, analyses and documentation.
                                              · XRD, Raman spectroscopy, FTIR, NIR, DSC, TGA, microscopy , SEM, surface area, PSD by Laser diffraction instruments, operation, methods and techniques.
                                              · FDA, USP, EP, JP, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
                                              · Product formulations, product stability, packaging, and FDA submission methods and practices.
                                              · Advanced Chemistry, pharmaceutical and statistical theories, methods and procedures.
                                              · Business, scientific and personal computer hardware and software applications.
                                              · Business English usage, spelling, grammar and punctuation.
                                              · Supervision, leadership and training practices and methods.
                                              · Current Company policies, practices and procedures, including safety rules and regulations.
                                              Skill in: · Responding to inquiries from management, employees and regulatory agencies.
                                              · Working with a high degree of independence and of conceiving and achieving technical goals with little or no technical supervision. Training of junior staff.
                                              · Directing the activities of technical personnel; making decisions and satisfying the needs of a research program.
                                              · Communicating clearly and concisely, both orally and in writing.
                                              · Operating scientific and personal computers.
                                              · Managing multiple projects, duties and assignments.
                                              · Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
                                              · Coordinating and reviewing the work of assigned department personnel.
                                              · Technical Report Writing
                                              · 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. Work is performed in a laboratory environment.
                                              Education
                                              . Minimum Qualifications : Bachelor’s Degree in Science or related scientific field from an accredited college or university, and seven (7) years related pharmaceutical laboratory experience, or Master’s Degree in Science or related scientific field from an accredited college or university, and five (5) years experience, or Doctorate’s Degree with one (1) year experience

                                              Watson Pharmaceuticals - 19 months ago - save job - block