Senior Chemist

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

Provide specialized technical support within the Quality Assurance Laboratory as assigned. Provide leadership/training to less experienced staff, as assigned to assure efficient and valid analytical laboratory support the Bristol site. Assist with supervisory duties in the absence of Management (including review and approval of analytical data per cGMPs and regulatory requirements). Perform analytical testing of all sample types as assigned. Assist with development and validation of chemical assays.

Lead installation, validation and troubleshooting new and existing equipment, including automated systems, as assigned. Assist Management in improving efficiency and compliance status of laboratories.

• Perform technical duties in specialized area or function as leader in absence of management, as assigned. Assist laboratory supervisors with tasks, as needed
• Perform efficient and reliable analytical tests following validated procedures for a wide variety of methods and sample types as assigned
• Document all results in accordance with cGMPs and written procedures
• Trouble-shoot and solve problems with assays and equipment with little or no supervision. Report all observations
• Recommend changes to methods and operations as appropriate
• Interpret analytical results correctly, notifying Management promptly of both situations that indicate analytical issues and manufacturing or product issues
• Develop/implement appropriate corrective and preventative actions (CAPA)
• Maintain the QC laboratories to comply with cGMP and USAntibiotics' standards of safety, quality, and cleanliness
• Participate in analytical method validations or transfers as required
• Perform satisfactorily on all analyst qualification studies, indicating technical proficiency
• Plan, perform, and document non-routine tests (or special studies) and investigations under the direction of Manager
• Evaluate and utilize state-of-the-art equipment including automated systems and computerized systems to perform testing and meet the goal of improved assay performance, including reliability , cost and assay characteristics
• Maintain and improve proficiency of operations through training
• Write validation reports, analytical procedure SOPs and equipment SOPs as required
• Notify Management of any SOPs that may require revision and initiate change requests per written policy, providing sufficient evidence/documentation to support change request
• Conduct special studies in accordance with protocols and direction of management. Prepare well documented reports of results
• Carry out other departmental duties as deemed appropriate by supervisor/manager
• Broaden understanding of subtleties of the techniques utilized by keeping current with technical and professional literature, attending technical discussions both inside and outside the USAntibiotics' community
• Provide technical and professional expertise to less experienced staff in the laboratory
• Serve as technical resource during Regulatory inspections and internal audits as required. Also, conduct internal audits and self-inspections as required. Provide information to outside vendors and technical representatives in a professional manner
• Review (i.e., validate) and approve analytical results for other laboratory personnel as assigned
• Assist management in conducting analytical failure investigations, as required, following all procedures
• Responsible for calibrating and maintaining assigned laboratory equipment according to schedules and procedures, documenting all results
• Lead equipment qualifications, drafting protocols and summary reports, as directed by management

• Analytical Methodology/Instrumentation Mastery
• LIMS
• SAP
• Compendial/Regulatory Expertise

• BS/BA degree in Chemistry (or related science) or equivalent related analytical experience

• Master's Degree in Chemistry (or related science) and/or approximately 7 years scientific work experience, which includes a specialized skill
• Previous pharmaceutical industry experience

• Minimum of 5-10 years of analytical experience in pharmaceutical industry and/or other scientific experience
• Strong knowledge/experience of cGMPs in areas beyond QC laboratory

• Demonstrated ability to perform a wide variety of chemical, instrumental, and chromatographic analyses
• Demonstrated mastery of skills at Chemist level and/or expertise in specific topic
• Advanced computer skills
• Advanced method development and trouble‑shooting skills
• Thorough understanding of chemical theory on which test methodology is based with strong…