Job Description

Position Title: Scientist I, Analytical Development

Department:Product Development

Reports To:Director, Analytical Development

FLSA:Exempt

Grade:C2

Date:June 15, 2016

Purpose and Scope

Independently develops, tests, validates and approves new test methods and procedures for chemical and instrumental methodology to ensure accuracy and consistency.

Essential Duties & Responsibilities

  • Perform analytical chemistry research to develop assays based on new and existing methodologies.
  • Develop, establish and validate testing methodology used to control raw materials, production intermediates and final products.
  • Establish, validate and document new or existing compound identification methods.
  • Provide analysis and evaluation of materials and products at all stages of development process.
  • Guide the work of junior staff members.
  • Coordinate project team efforts.
  • Accurately record and make detailed observations, analyze data, interpret results and issue reports.
  • Exercise technical discretion in design, execution and interpretation of data.
  • Contact outside laboratories, participate in scientific conferences, and contribute to scientific journals.
  • Maintain knowledge of advancements in analytical chemistry.
  • Conduct work in compliance with cGMP, safety and regulatory requirements.
  • Evaluate active pharmaceutical product technical packages for source selection.
  • Review regulatory documents for submission to the FDA. Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Respond to spills per CP 030-0202 Chemical Spill Response.
  • Perform other related duties as assigned.

Knowledge, Skills & Abilities

  • Proficient in method development and validation.
  • Knowledge of government regulations for drugs and medical devices including GMP, GLP and ICH.
  • Good working knowledge of USP, NF and extraction techniques.
  • Familiar with sample preparation from a variety of matrices.
  • Experience with computer systems for sample tracking, laboratory equipment, raw data handling.
  • Demonstrated proficiency in word processing, graphics and spreadsheets.
  • Experience in writing technical reports and data summaries for submissions to company management as well as to government agencies.
  • Strong written and oral communication skills.
  • Ability to work well independently and with others and ability to effectively multi-task.
  • Ability to operate and maintain analytical laboratory instruments such as HPLC, KF, GPC, GC, and UV-Vis spectrophotometers.
  • Project leader abilities including organizing and guiding other members of an interdisciplinary team.

Education& Experience

  • BS, MSor PhD in Chemistry, Biochemistry or Pharmaceutical Sciences.
  • Pharmaceutical laboratory work experience combined with degree. BS: 5 or more years; Masters: 2 or more years or PhD: 0 or more years.

Working Conditions

  • Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

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