Position Summary
The Analytical Scientist is responsible for performing a wide range of tests to assess the quality of raw materials, in-process materials, finished products, and cleaning verification/validation samples to ensure compliance with established regulatory and company standards. This role leads analytical method development and validation activities, conducts both routine and non-routine testing, and plays a key role in laboratory investigations, documentation, and reporting. The position also serves as a technical liaison with clients, supporting method development, data interpretation, and investigative efforts.
Key Responsibilities:
- Conduct and validate analytical testing of raw materials, intermediates, finished products, environmental samples, and stability batches.
- Develop, validate, and implement new analytical methods, including those for cleaning verification (e.g., via HPLC).
- Author detailed analytical protocols, validation reports, and Certificates of Analysis.
- Troubleshoot analytical methods and laboratory equipment.
- Compile, interpret, and document analytical data following cGMP standards.
- Maintain accurate laboratory records including notebooks, worksheets, and batch records.
- Review and peer-check laboratory documentation for accuracy and compliance.
- Lead investigations into Out-of-Specification (OOS) and Out-of-Tolerance (OOT) results, and communicate findings per SOPs.
- Support environmental monitoring efforts as needed.
- Train and lead a team of analytical scientists and technicians.
- Ensure adherence to SOPs, cGMP, ICH, USP/EP, ISO, and regulatory guidelines (21 CFR Parts 210, 211, and 820).
- Interact with clients regarding laboratory activities, including method development and investigation outcomes.
- Perform other related duties as assigned.
Qualifications:
- Bachelor's degree in Chemistry or a related scientific field.
- 2-4 years of analytical laboratory experience.
- Extensive knowledge of cGMP, FDA (21 CFR Parts 210, 211, 820), ICH, EU, and ISO standards.
- Strong expertise in pharmacopeial requirements (USP, EP, etc.).
- Experience in specialized testing such as dissolution or aerosol analysis is preferred.
- Proven ability to develop and validate complex analytical methods.
- Excellent written and verbal communication skills, including the ability to present findings internally and externally.
- Highly skilled in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Strong organizational skills, attention to detail, and manual dexterity.
- Ability to interpret and follow complex documents such as SOPs, protocols, and regulatory guidelines.
- Capable of clear and effective communication with internal teams and external clients.
- Proficient in applying arithmetic and basic statistical concepts to analytical processes.