Date: 20-May-2011
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LTS Scientist III
Essential Job Functions:
Carries out responsibilities in accordance with the organizations policies, procedures,
and state, federal and local laws.
Writes method investigation/method validation protocols, executes approved laboratory
protocols, and writes reports. Investigations may be complex and validations may require
advanced technical and analytical problem solving skills.
Interprets analyses findings, identifies and reports on how technique differences at
various stages of the analytical process impact the results.
Conducts non-routine testing such as evaluation of USP proposals/revisions, routine
cleaning validation testing and reference standard qualification.
Performs qualitative and quantitative analyses in support of method transfers and method
comparisons following established procedures and approved protocols.
Performs more advanced analyses, which require a higher level of technical skill and
knowledge (e.g., AA spectrometry, GC).
Participates in method development projects.
Participates in team efforts to evaluate, strategize, solve method-related investigations
and improve compliance and/or efficiency.
May be a qualified trainer or reviewer, and oversee projects of junior staff members.
Performs advanced troubleshooting of instruments/equipment.
Carries out cGMP and technical training, as it pertains to area of work.
Provides support and coaching to subordinate employees in the areas of training,
planning, and work assignment.
May develop, write and review new procedures, test methods and specifications
documents. May also update existing procedures, test methods and specifications
documents.
Ensures project deadlines and performance standards are established and met.
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:
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
and other regulatory requirements.
Pertinent SOPs related to pharmaceutical laboratory testing, analyses and
documentation.
UV/IR, HPLC, AA and GC instruments, dissolution testing, operation methods and
techniques.
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
regulations.
Skill in:
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
personnel.
Establishing and maintaining cooperative working relationships with others.
Ensuring compliance with all Company policies and procedures, including safety rules
and regulations.
Education
Physical Requirements and Working Conditions: Incumbents in this class are subject to
extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and
occasional business travel. Work is performed in an office environment.
Minimum Qualifications: Bachelors Degree in Chemistry or related science field from an
accredited college or university with five (5) to eight (8) years experience; or an equivalent
combination of education and experience. Pharmaceutical experience a plus.
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
