Kelly
Senior Analytical Associate II
Kelly Science & Clinical is seeking Senior Analytical Associate II for a direct hire position with a Biopharma CDMO client at their site in Harleysville PA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Compensation: $95,000-$105,000/yr Schedule: Monday-Friday, 1st shift Location: Harleysville, PA Duration: Direct hire Summary: We are seeking a highly experienced Senior Analytical Associate II to join our Laboratory CDMO team. This role is crucial for supporting our manufacturing campaigns and requires an expert blend of 8-15+ years of pharmaceutical industry experience, especially in small molecule method development and validation. The position maintains a roughly 50/50 split between hands-on analytical bench work (primarily HPLC/UPLC) and leading complex technical writing and documentation efforts (SOPs, protocols, and reports) under strict cGxP guidelines. Responsibilities: Execute and lead analytical method development and validation activities, critically focused on small molecule methods, utilizing HPLC/UPLC instrumentation. Provide high-level oversight and coordination of analytical testing to ensure all materials are tested to current specifications in support of upcoming manufacturing campaigns. Perform extensive technical writing activities, including the generation of validation protocols, Standard Operating Procedures (SOPs), technical reports, and drug product/excipient monograph revisions. Coordinate laboratory testing activities both internally and externally, including managing sample shipment and receipt within the analytical laboratory. Ensure all laboratory work and documentation strictly adhere to cGxP (GMP, GLP, GDP) principles. Represent the analytical laboratory in client meetings as needed to discuss technical findings and documentation status. Work effectively within a core analytical team of four colleagues. Qualifications: College degree in chemistry or a related scientific discipline. 8-15+ years of experience in the pharmaceutical industry, with a focus on solid and liquid dosage forms. Minimum 4+ years of experience in analytical method development and/or validation, specifically for small molecules. Expert, hands-on experience operating and troubleshooting HPLC/UPLC instrumentation. Extensive experience with and strong working knowledge of cGxP principles. Proven experience with technical writing activities associated with method validations, SOPs, protocols, and technical reports. Fluent English language skills (both written and spoken). Preferred Experience & Attributes: Direct experience utilizing Empower software. Experience with dissolution apparatus 1 and/or 2. Minimum 5 years of experience in a cGMP laboratory. Highly organized, detail-focused, with strong problem-solving and risk mitigation skills. Client services approach and mindset (internal and external).
Kelly Science & Clinical is seeking Senior Analytical Associate II for a direct hire position with a Biopharma CDMO client at their site in Harleysville PA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Compensation: $95,000-$105,000/yr Schedule: Monday-Friday, 1st shift Location: Harleysville, PA Duration: Direct hire Summary: We are seeking a highly experienced Senior Analytical Associate II to join our Laboratory CDMO team. This role is crucial for supporting our manufacturing campaigns and requires an expert blend of 8-15+ years of pharmaceutical industry experience, especially in small molecule method development and validation. The position maintains a roughly 50/50 split between hands-on analytical bench work (primarily HPLC/UPLC) and leading complex technical writing and documentation efforts (SOPs, protocols, and reports) under strict cGxP guidelines. Responsibilities: Execute and lead analytical method development and validation activities, critically focused on small molecule methods, utilizing HPLC/UPLC instrumentation. Provide high-level oversight and coordination of analytical testing to ensure all materials are tested to current specifications in support of upcoming manufacturing campaigns. Perform extensive technical writing activities, including the generation of validation protocols, Standard Operating Procedures (SOPs), technical reports, and drug product/excipient monograph revisions. Coordinate laboratory testing activities both internally and externally, including managing sample shipment and receipt within the analytical laboratory. Ensure all laboratory work and documentation strictly adhere to cGxP (GMP, GLP, GDP) principles. Represent the analytical laboratory in client meetings as needed to discuss technical findings and documentation status. Work effectively within a core analytical team of four colleagues. Qualifications: College degree in chemistry or a related scientific discipline. 8-15+ years of experience in the pharmaceutical industry, with a focus on solid and liquid dosage forms. Minimum 4+ years of experience in analytical method development and/or validation, specifically for small molecules. Expert, hands-on experience operating and troubleshooting HPLC/UPLC instrumentation. Extensive experience with and strong working knowledge of cGxP principles. Proven experience with technical writing activities associated with method validations, SOPs, protocols, and technical reports. Fluent English language skills (both written and spoken). Preferred Experience & Attributes: Direct experience utilizing Empower software. Experience with dissolution apparatus 1 and/or 2. Minimum 5 years of experience in a cGMP laboratory. Highly organized, detail-focused, with strong problem-solving and risk mitigation skills. Client services approach and mindset (internal and external).