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Senior Analytical Method Development Analyst - NY

Company: Curia
Location: Decatur
Posted on: March 20, 2023

Job Description:


Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Analytical Department is responsible for support of the manufacturing department and external customers. The routine functions of the laboratory are testing of raw materials, in-process, end product, and stability samples. The department also performs particulate testing and tests plant water for production. The Senior Analytical Method Development Analyst's principal responsibility is the design, development, validation and implementation of analytical procedures. This position is an effective Project Leader on multiple projects simultaneously and tracks the progress of the project so that it remains on-time and within expected budgets.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.

Essential job duties

  • Understand the tests necessary to characterize an API and continually expands technical knowledge
  • Apply research knowledge to plan and manage project for self and for direct reports and develop strategies that guide the project
  • Propose new initiatives
  • Assist and lead direct reports and team members in problem-solving and new methodology
  • Provide new ideas based on interpretation of data
  • Develop technical solutions to complex problems
  • Perform complex Liquid/Gas Chromatography and UPLC trouble shooting
  • Interact with outside departments including attending meetings, providing updates, etc.
  • Participate in technical discussions with customers about analytical issues
  • Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
  • Implement work plans; conduct performance reviews with the assistance of a higher-level manager. Identify and recommends career development opportunities with employees. Work is performed without appreciable direction

    Supervisory responsibilities

    This position may have supervisory responsibilities.

    Education, experience, certification and licensures

  • Bachelor's degree in Analytical Chemistry or relevant degree
  • Minimum 9 years' relevant experience, including 2 years in a cGMP or GLP pharmaceutical industry environment and 2 years' supervisory experience
  • Chemical Hygiene training

  • Ph.D. Degree in Analytical Chemistry or relevant degree
  • Minimum 4 years' experience

  • Master's degree in Analytical Chemistry or relevant field
  • Minimum 7 years relevant experience

    Knowledge, skills and abilities
  • Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH)
  • Expertise in the drug development process, the internal steps necessary to manufacture API at this site, as well as the theoretical and practical aspects of general analytical chemistry
  • Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
  • Ability to write speeches and articles for publication that conform to prescribed style and format
  • Ability to effectively present information to top management, public groups and/or boards of directors

    All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Keywords: Curia, Decatur , Senior Analytical Method Development Analyst - NY, Professions , Decatur, Illinois

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