Analytical Scientist

Job Title:

Analytical Scientist

Job Description

The Analytical Scientist supports research and development activities by performing a wide range of analytical testing to assess the quality of raw materials, in-process intermediates, finished products, and cleaning verification/validation samples. This role ensures that all materials and products meet established quality standards and regulatory requirements, contributes to method development and validation, and provides critical analytical data to support manufacturing, quality, and environmental monitoring activities in a pharmaceutical setting.

Responsibilities

* Support Analytical Laboratory Services in the development, maintenance, and continuous improvement of laboratory practices and procedures.

* Perform routine and non-routine scientific analyses to evaluate the quality of raw materials, in-process materials, environmental samples, finished goods, and stability samples.

* Develop, conduct, and validate a variety of chemical assays to support product development, manufacturing, and quality control.

* Develop, evaluate, and validate analytical methods, including methods for cleaning verification using HPLC and related techniques.

* Collect and analyze routine equipment cleaning verification and validation samples, ensuring accurate and timely reporting of results.

* Compile, interpret, and document data from analytical tests in accordance with internal procedures and regulatory standards.

* Troubleshoot analytical methods and laboratory equipment to resolve technical issues and improve method robustness and reliability.

* Prepare Certificates of Analysis and detailed analytical reports for internal stakeholders and external clients as required.

* Prepare, organize, and maintain raw data and records for review, ensuring data integrity and traceability.

* Document all analyses in laboratory notebooks, worksheets, and production batch records as applicable, following cGMP and SOP requirements.

* Peer-review laboratory records to ensure accuracy, completeness, and compliance with internal and regulatory standards.

* Communicate quality or compliance concerns promptly to leadership with appropriate urgency and clarity.

* Support Out-of-Specification (OOS) and Out-of-Tolerance (OOT) laboratory investigations and communicate findings to Quality and Operations in line with internal SOPs.

* Support environmental monitoring activities as required, contributing to a robust quality and compliance program.

* Ensure strict compliance with Standard Operating Procedures (SOPs), cGMPs, and applicable regulatory standards including EU, 21 CFR Parts 210, 211, and 820, ISO, and ICH guidelines.

* Collaborate with clients on topics such as method development, data interpretation, and investigation outcomes, providing clear and professional communication.

* Deliver internal and external presentations on analytical methods, data, and findings when required.

* Perform other related duties as assigned to support laboratory operations and organizational objectives.

Essential Skills

* Bachelor's degree in Chemistry or a closely related scientific field.

* Minimum of 3 years of analytical laboratory experience in a pharmaceutical or closely related environment.

* At least 3 years of hands-on experience with HPLC method development, validation, and transfer/verification.

* Demonstrated experience running HPLC in a laboratory setting, including routine and non-routine analyses.

* Strong background in analytical chemistry, including development and validation of chemical assays.

* Familiarity with cGMPs and regulatory frameworks such as EU regulations, 21 CFR Parts 210, 211, and 820, ISO, and ICH guidelines.

* Solid understanding of pharmacopeial standards, including USP, EP, and other relevant pharmacopeias.

* Specific experience in either dissolution testing or aerosol testing.

* Excellent written and verbal communication skills, including the ability to deliver internal and external presentations.

* Ability to read and interpret documents such as standard operating procedures, manuals, experimental protocols, and analytical methods.

* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or equivalent software.

* Strong organizational skills with attention to detail and the ability to manage multiple tasks and data sets.

* Hands-on coordination, manual dexterity, and meticulous attention to detail in laboratory work.

* Legible handwriting for accurate and clear laboratory recordkeeping.

* Ability to communicate clearly in writing and orally, including drafting standard operating procedures and work instructions.

* Capability to apply basic arithmetic concepts such as addition, subtraction, fractions, percentages, ratios, and proportions to practical laboratory calculations.

Additional

Skills & Qualifications

* Experience communicating directly with clients regarding method development, data interpretation, and investigation results.

* Experience supporting OOS and OOT investigations in a regulated…