Summary: Under limited supervision, participates as a team member in method developmentand 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. The 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
- 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 methods for testing raw materials, IP, FP and ST sample testing such as
HPLC, Gas Chromatography (GC), UV, automatic titrator, IR, AA and TLC and
dissolution testing; 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
- 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
- Performs related duties as assigned.
Knowledge of: - Pertinent SOPs related to pharmaceutical laboratory testing, analyses and
- UV/IR, HPLC, GC and TLC and dissolution testing instruments operation methods and
- FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
- Product formulations, product stability, packaging, and FDA submission methods and
- 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
- 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.
- Leading 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.
- 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
Minimum Qualifications: Bachelor’s Degree in Science or related scientific field from anaccredited college or university, and nine (9) years related pharmaceutical laboratory experience,
or an equivalent combination of education and experience.
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