Summary: Under minimum supervision, performs highly technical and specialized Analytical
Scientist duties, research on assigned problems and studies in support of Watson?s method
development, method validation and complex technical investigation efforts. Performs testing of
raw materials, in process (IP), finished product (FP) and stability (ST) samples, maintenance and
calibration of analytical instruments, and carries out assigned laboratory work to support method
development validation and complex technical investigations. 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 lead responsibilities in accordance with the organization?s policies,
procedures, and state, federal and local laws.
Reviews notebooks, supporting documents, and others to support the daily activities of
assigned laboratory staff.
Operates general analytical instruments during testing with raw material, IP, FP and ST
sample testing such as HPLC, Gas Chromatography (GC), UV, automatic titrator, IR, AA,
TLC and dissolution testing.
Performs wet chemistry tests on samples such as LOD, pH, and titration; prepares
standard and sample solutions as required by test methods; and performs all necessary
calculations associated with the test analyses.
Revises specification reports and test methods for raw materials and finished products.
Labels, transcribes and records documentation such as report sheets and laboratory
notebooks as required by Standard Operating Procedures (SOPs).
Cleans, maintains and calibrates laboratory equipment to ensure compliance with cGLP
Writes Standard Operation Procedures (SOPs), policies and laboratory related reports.
Performs physical testing such as particle size and thermal analysis.
Performs complex investigations, method validations and method development.
Carries out quantitative and qualitative analyses including but not limited to reference
standard qualifications, method comparisons and method transfers.
Participates in the training of departmental employees.
Provides support and coaching to subordinate employees in the areas of training,
planning, and work assignment.
Ensures project deadlines and performance standards are established and met.
Ensures compliance with all Company policies and procedures, including safety rules and
Performs related duties as assigned.
Required Knowledge and Skills:
* Pertinent SOP?s related to pharmaceutical laboratory testing, analyses and
* UV/IR, HPLC, GC, and TLC instruments, dissolution testing, operation methods and
* Business, scientific and personal computer hardware and software applications.
* Business English usage, spelling, grammar and punctuation.
* Wet Chemistry and Chemistry related to sampling methods, quality control systems,
* analysis and documentation practices and procedures.
* FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
* Spectroscopic and chromatographic operation, techniques and systems.
* 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.Communicating clearly and concisely, both orally and in writing.
* Operating scientific and personal computers.
* Managing multiple projects, duties and assignments.
* Coordinating, delegating assignments and reviewing the work of assigned department
* 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.
Minimum Qualifications: Bachelor?s Degree in Chemistry or related science field from an
accredited college or university with five (5) years related laboratory experience or an equivalent
combination of education and experience.