Catalent
Overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent supports product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with multiple global sites and a broad range of service offerings. This is a full-time on-site position at San Diego, CA. The Role
Scientist 2, Analytical Development is responsible for analytical development for solid oral and injectable drug candidates for human clinical studies, as well as preclinical drug products. The role includes developing timelines, planning experiments, coordinating activities, and possibly delegating tasks to meet client expectations. Develop and qualify analytical test methods, particularly stability indicating assays, dissolution methods, product-specific cleaning methods, and water content methods for one or more drug product dosage forms. Assist in creation and/or revision of company SOPs and participate in continuous improvement projects as needed. Lead training and mentoring of colleagues and assist QC/QA in investigations as a Subject Matter Expert (SME). May supervise lab assistants and/or one full-time employee. Perform and train others on a variety of analytical techniques and instruments (e.g., HPLC/UPLC, UV/Vis, GC, DSC, PXRD, FT-IR, TGA, SEM, dissolution apparatus, Karl Fischer, and related physical testing like hardness and friability). Maintain clear and accurate laboratory records, prepare technical reports for clients, and contribute to discussions with clients on technical topics related to their projects. Collaborate with other departments to troubleshoot issues and ensure compliance with GMP and SOPs. Adhere to and uphold Catalent safety, quality, and regulatory standards in all duties. Responsibilities (selected)
Complex experimental design and execution with minimal supervision; develop strategic experimental plans and timelines, including cleaning verification methods. Independently design, execute, and interpret experiments with guidance on complex issues; ensure data integrity and scientific accuracy in notebooks and reviews. Prepare client-facing documents and technical reports; participate in client discussions on technical topics. Primary responsibility for individual client projects with supervisory support; lead client meetings on technical topics as appropriate. Supervise laboratory staff as assigned and collaborate cross-functionally to troubleshoot technical problems. Qualifications
Bachelor’s degree in a physical, chemical, biological, or pharmaceutical science with a minimum of three years of applicable industry experience; or MS with two years, or PhD with no formal industry experience. Experience in analytical development and method development with instrumentation including HPLC/UPLC, UV/Vis, GC, dissolution testing, moisture analysis (Karl Fischer), PXRD, DSC, FT-IR, TGA, SEM, and related testing such as disintegration, hardness, and friability. Proficiency in developing and qualifying analytical test methods for APIs, intermediates, and final drug products, especially stability-indicating assays, GC, dissolution, and water content methods; experience with physical characterization techniques (TGA, DSC, PXRD, GVS, SEM). Ability to function in a fast-paced, regulated environment with GMP knowledge and strong technical writing skills. Ability to walk, sit, stand, and lift up to 25 pounds; visual and motor skills to operate laboratory equipment and review documents. Pay
Salary range in San Diego, CA: $90,000 to $115,000 annually. Final offer dependent on experience, education, skillset, and business needs. Why you should join Catalent
Competitive compensation and benefits, career growth opportunities, and a supportive, fast-paced work environment. On-site facilities and programs focused on wellness, diversity, and inclusion. Tuition reimbursement, 401(k) with company match, paid time off, and other employee-focused benefits. Note: Catalent is an Equal Opportunity Employer. Catalent provides accommodations for applicants with disabilities upon request.
#J-18808-Ljbffr
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent supports product development, launch, and full life-cycle supply for pharma, biotech, and consumer health customers, with multiple global sites and a broad range of service offerings. This is a full-time on-site position at San Diego, CA. The Role
Scientist 2, Analytical Development is responsible for analytical development for solid oral and injectable drug candidates for human clinical studies, as well as preclinical drug products. The role includes developing timelines, planning experiments, coordinating activities, and possibly delegating tasks to meet client expectations. Develop and qualify analytical test methods, particularly stability indicating assays, dissolution methods, product-specific cleaning methods, and water content methods for one or more drug product dosage forms. Assist in creation and/or revision of company SOPs and participate in continuous improvement projects as needed. Lead training and mentoring of colleagues and assist QC/QA in investigations as a Subject Matter Expert (SME). May supervise lab assistants and/or one full-time employee. Perform and train others on a variety of analytical techniques and instruments (e.g., HPLC/UPLC, UV/Vis, GC, DSC, PXRD, FT-IR, TGA, SEM, dissolution apparatus, Karl Fischer, and related physical testing like hardness and friability). Maintain clear and accurate laboratory records, prepare technical reports for clients, and contribute to discussions with clients on technical topics related to their projects. Collaborate with other departments to troubleshoot issues and ensure compliance with GMP and SOPs. Adhere to and uphold Catalent safety, quality, and regulatory standards in all duties. Responsibilities (selected)
Complex experimental design and execution with minimal supervision; develop strategic experimental plans and timelines, including cleaning verification methods. Independently design, execute, and interpret experiments with guidance on complex issues; ensure data integrity and scientific accuracy in notebooks and reviews. Prepare client-facing documents and technical reports; participate in client discussions on technical topics. Primary responsibility for individual client projects with supervisory support; lead client meetings on technical topics as appropriate. Supervise laboratory staff as assigned and collaborate cross-functionally to troubleshoot technical problems. Qualifications
Bachelor’s degree in a physical, chemical, biological, or pharmaceutical science with a minimum of three years of applicable industry experience; or MS with two years, or PhD with no formal industry experience. Experience in analytical development and method development with instrumentation including HPLC/UPLC, UV/Vis, GC, dissolution testing, moisture analysis (Karl Fischer), PXRD, DSC, FT-IR, TGA, SEM, and related testing such as disintegration, hardness, and friability. Proficiency in developing and qualifying analytical test methods for APIs, intermediates, and final drug products, especially stability-indicating assays, GC, dissolution, and water content methods; experience with physical characterization techniques (TGA, DSC, PXRD, GVS, SEM). Ability to function in a fast-paced, regulated environment with GMP knowledge and strong technical writing skills. Ability to walk, sit, stand, and lift up to 25 pounds; visual and motor skills to operate laboratory equipment and review documents. Pay
Salary range in San Diego, CA: $90,000 to $115,000 annually. Final offer dependent on experience, education, skillset, and business needs. Why you should join Catalent
Competitive compensation and benefits, career growth opportunities, and a supportive, fast-paced work environment. On-site facilities and programs focused on wellness, diversity, and inclusion. Tuition reimbursement, 401(k) with company match, paid time off, and other employee-focused benefits. Note: Catalent is an Equal Opportunity Employer. Catalent provides accommodations for applicants with disabilities upon request.
#J-18808-Ljbffr