Analytical Research Scientist I

2 weeks ago

Chantilly, Virginia, United States Granules Full time
Position Overview

Location: US Based Candidates Only

Role Summary:

As a Scientist I within the Analytical Research & Development division, you will play a crucial role in evaluating product development samples and providing timely analytical support to the R&D team. Your responsibilities will encompass conducting Assay Dissolution, developing analytical methods, and validating these methods, which includes the preparation of validation and verification protocols. Furthermore, you will oversee the testing and release of in-process, finished product, and stability samples, including process evaluation samples.

Adhering to Standard Operating Procedures (SOPs) is essential for the safe and efficient execution of your duties in this position.

Key Responsibilities:

  • Expertly operate laboratory instruments and equipment, such as FTIR, HPLC, UPLC, Dissolution apparatus, ICP-MS, GC, UV-Vis, Karl Fischer (KF), Ion Chromatography (IC), and Malvern Mastersizer.
  • Assist the R&D team by analyzing process development samples for content uniformity, blend uniformity, assay, particle size distribution, density, water determination via KF, viscosity, and other necessary tests.
  • Engage in analytical method development, optimization, validation, verification, and transfer for finished products.
  • Prepare test methods, validation protocols, and reports in accordance with company SOPs and regulatory standards.
  • Conduct additional analytical testing (e.g., multimedia dissolution, photostability, dose dumping) for regulatory submissions.
  • Ensure timely execution and completion of assigned tasks.
  • Accurately document experiments and maintain all associated records (including instrument, standard, and column usage logbooks) in compliance with internal SOPs and FDA regulations.
  • Maintain a clean and organized laboratory environment in accordance with current Good Manufacturing Practices (cGMP).
  • Identify and communicate opportunities for continuous improvement to the Analytical Manager and Director.
  • Monitor the availability of chemicals, columns, standards, and other consumables necessary for sample testing.
  • Perform other duties as assigned by management based on operational needs.

Management Responsibilities:

  • Assign daily work schedules in a timely manner.
  • Provide guidance in method development and validation.
  • Interpret and review results generated.
  • Support professional development initiatives.

Qualifications:

Education & Experience:

  • Bachelor's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field with over 5 years of relevant experience in the pharmaceutical industry OR
  • Master's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field with at least 2 years of relevant experience in the pharmaceutical industry.
  • Familiarity with Good Manufacturing Practices (cGMP).
  • Proficiency in software and information systems (e.g., Empower, Microsoft Word, and Excel).

Required Knowledge, Skills, & Abilities:

  • Strong understanding of major analytical techniques and operation of instruments such as HPLC, GC, dissolution, FT-IR, UV-VIS Spectrophotometer, particle size analysis (Malvern Mastersizer, sonic sifting, and sieve shaker), Karl Fischer Instrument, potentiometric titration, density meter, pH meter, melting point apparatus, analytical balances, and viscometer.
  • Experience in HPLC method development and validation.
  • Proficient in documentation practices in line with Good Documentation Practices.
  • Computer literacy, including proficiency in Microsoft Office applications.
  • Excellent verbal and written communication skills.

Physical Requirements/Working Environment:

  • Ability to stand for extended periods (up to 12-hour shifts), lift at least 40 pounds, wear a respirator, and meet associated testing requirements, along with wearing all necessary personal protective equipment (PPE).
  • Vision capabilities must include the ability to see details at close range.

Disclaimer:

The information provided in this description is intended to convey the general nature and level of work performed by employees in this classification. It is not intended to be a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

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