The Senior Chemist is a highly experienced analytical professional with a minimum of 10 years of progressive laboratory experience within a regulated pharmaceutical or OTC environment. This role provides advanced technical expertise in method development, validation, transfer, and troubleshooting, while ensuring full compliance with current compendial and regulatory requirements, including USP, FDA regulations (21 CFR), and applicable PCPC guidelines.

 The Senior Chemist serves as a technical leader within the laboratory, mentoring junior chemists, driving continuous improvement, and supporting regulatory inspections and audits. This position requires strong scientific judgment, leadership capability, and the ability to manage complex analytical projects independently.

 Key Responsibilities:

• Facilitate special projects and complex assignments as delegated (method transfer, method development, method validation, investigations, technical troubleshooting).
• Ensure compliance with all relevant regulations for all products, including USP and FDA guidelines, as applicable.
• Lead, direct, mentor, and train junior Chemists in instrumentation, analytical methodology, SOPs, Test Methods (TM), GLP, cGMP, data integrity requirements, and laboratory best practices.
• Perform and oversee advanced chemical testing using approved TMs, SOPs, and USP/NF methodologies on raw materials, bulk liquids, in-process samples, and finished products. Testing may include, but is not limited to: HPLC, GC, IR, UV-Vis, auto-titrator, wet chemistry, and other compendial or validated techniques.
• Drive technical troubleshooting of analytical instrumentation and laboratory processes to ensure minimal downtime and data reliability.
• Perform a comprehensive review of laboratory notebooks, raw data, and technical documentation for accuracy, completeness, and regulatory compliance.
• Demonstrate a thorough and applied understanding of USP and cGMP requirements as they relate to pharmaceutical and OTC testing.
• Author and execute validation protocols and technical reports for method development, transfer, and validation activities.
• Analyze and interpret experimental data to make, report and document scientific conclusions.
• Develop, optimize, and modify analytical testing methods for incoming material testing, in-process release testing, and finished product release testing using appropriate analytical equipment and scientifically sound methodology.
• Conduct and support investigations, including OOS, OOT, No Tests, deviations, and CAPA with appropriate root cause analysis and documentation.
• Assist in preparing the laboratory and provide technical support for internal, customer, and regulatory audits and inspections.
• Coordinate release of liquid batches, including assignment of re-assay and expiration dates based on stability data and regulatory guidelines.
• Support sampling, testing, and release of raw materials, in-process and finished goods, as needed.

 Education/Experience:

• Bachelor’s degree in chemistry, Analytical Chemistry, or related scientific discipline required. 
• Minimum of ten (10) years of progressively responsible analytical laboratory experience in a regulated pharmaceutical or OTC manufacturing environment. 
• Demonstrated experience in method development, validation, method transfer, and regulatory inspection support.

Required Knowledge: 

• Advanced knowledge of analytical chemistry principles and instrumentation.
• In-depth understanding of cGMP, GLP, 21 CFR, USP, and regulatory compliance requirements.
• Strong technical writing and documentation skills.
• Proven ability to independently manage complex analytical projects and make scientifically sound decisions.
• Strong organizational, problem-solving, and communication skills.
• Ability to explain technical information to a non-technical audience.