Summary: Under limited direction and supervision, participates as a project team leader and/ormember in Method development and validation and complex technical investigations efforts.
Performs highly technical and specialized professional Analytical Scientist duties. Performs
research on assigned problems and studies in support of the Company's efforts. Identifies,
analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory
compliance issues. Provides intra- and inter-departmental 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.
- May supervise, coordinate, prioritize and lead the daily activities of a group of intra- and
inter-departmental team members, including Analytical Scientists, and schedules their
- Coordinates and executes assigned projects and activities; develops project goals and
timelines in compliance with Standard Operating Procedures (SOPs), Good Laboratory
Practices (GLPs), current Good Manufacturing Practices (cGMPs), Food and Drug
Administration FDA) and Drug Enforcement Agency (DEA) regulations and guidelines.
- Designs experimental plans, researches and critically analyzes data, statistical and
research information gathered in support of project directives. Performs and may oversee
the development and validation of methods for testing raw materials, drug substances
and drug dosage forms. Also may be 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.
- Maintains appropriate documentation of records, report sheets and laboratory notebooks
as required by SOPs and FDA.
- Ensures the cleanliness, calibration and maintenance of laboratory equipment and work
areas to ensure compliance with SOPs, GLPs and cGMPs.
- Prepares method development, method validation, analytical strategy, etc. reports and
other relevant scientific information packages for internal and external use by the
- Reviews, evaluates and modifies test methods and procedures, as needed.
- Ensures compliance with all Company policies and procedures, including safety rules and
- May oversee the analysis of competitor products, drug substances, excipients, and
experimental products to provide information for Product Development, the dissolution
testing of competitor products, the physical characterization of drug substances,
excipients, and dosage forms.
- Provides scientific and technical leadership to junior staff members in support of Product
Development meeting its project deadlines and performance standards. Collaborates
closely with Pharmaceutics to set priorities and reach Product Development objectives.
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- 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 the business.
- Provides formal and information 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.
- Performs related duties as assigned.
Knowledge of: - Pertinent SOP's related to pharmaceutical laboratory testing, analyses 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.
- Pharmaceutical testing laboratory programs and systems.
- Principles and practices of analytical instrumentation and testing.
- Principles of mathematical and statistical computations.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Team leadership, team building and training practices and methods.
- Technical Report Writing.
- Current Company policies, practices and procedures, including safety rules and
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- Analyzing problems, identifying alternative solutions, and implementing recommendations
for resolution of problems.
- Assisting in intra- and inter-departmental troubleshooting and problem solving.
- Responding to inquiries from management, employees and regulatory agencies.
- Communicating clearly and concisely, both orally and in writing.
- Working with a high degree of independence and of conceiving and achieving technical
goals with little or no technical supervision. Training of junior staff.
- Managing multiple projects, duties and assignments.
- Leading, coordinating and reviewing the work of assigned team members.
- Directing the activities of technical personnel; making decisions, and satisfying the needs
of a research program.
- Establishing and maintaining cooperative working relationships with others.
Minimum Qualifications: Bachelors degree in Science or related scientific field from anaccredited college or university, and fourteen (14) years related pharmaceutical laboratory
experience, or an equivalent combination of education and experience.
Physical Requirements and Working Conditions: 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