Catalent
Overview
The Associate Scientist is responsible for performing analytical research and development work in the Analytical R&D Department. The Associate Scientist will work on method development, method transfer, method verification and method validation under appropriate guidance, along with routine release and stability testing in support of clinical development and registration activities required for regulatory submissions. The Role
Perform technical review of client documents as required, including specification/validation reports/test methods/compliance reports, to perform gap analysis with respect to methods/instruments/procedures for completing methods transfers from client or third-party labs with guidance from supervisors/senior team members Analyze finished products, in-process materials, and raw materials according to assigned specifications, methods, and protocols in line with cGLP and cGMP; document, process, and report the data to support the team in a timely fashion Perform analyses to support testing using KF titrations, dissolutions, IR, UV spectroscopy, LC to perform dissolutions/assays/BU/CU, impurities, and data processing using Empower; document per applicable test methods/specifications/protocols with guidance from senior team members Use Empower software to create instrument/processing/report methods and perform online Empower calculations for assay/dissolutions/impurities; knowledge of TrackWise for managing deviations and investigations with guidance from supervisors/senior team members Troubleshoot and propose method improvement requirements during method feasibility work of client-supplied methods and during compendial method evaluation for assay, impurities, dissolution, etc., with guidance from supervisors/senior team members Perform or assist with method transfers, compendial verifications, or full method validations (forced degradation and calculating mass balance/peak purity to prove stability-indicating nature) per applicable guidances (USP, ICH Q2, etc.) and SOPs with guidance from the supervisors/senior team members Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols; escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members Other duties as assigned The Candidate
Bachelor's Degree in Chemistry, Pharmaceutical Sciences or Life Sciences is required; preferred major Analytical Chemistry At least one year of experience in the pharmaceutical industry and 1+ years of experience in analytical testing/research using HPLC/GC/UV, etc. Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, µg/mL, etc.), molarity, Beer's Law, reference standard purity on as is, anhydrous, or dry basis, etc. Basic understanding and knowledge of analytical chemistry and chromatographic techniques (e.g., LC/GC/dissolutions) and spectroscopic (e.g., UV) analysis Ability to understand and follow ICH guidelines (ICH Q1, Q2, Q3, etc.) including other regulatory guidelines Adhere to and perform all lab duties according to applicable SOPs related to safety, waste management and housekeeping; work with the team to improve processes and procedures Assist with lifting of liquid containers and objects greater than 50 lbs as required Why You Should Join Catalent
Several Employee Resource Groups focusing on D&I Tuition Reimbursement – let us help you finish your degree or earn a new one Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Catalent is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral.
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The Associate Scientist is responsible for performing analytical research and development work in the Analytical R&D Department. The Associate Scientist will work on method development, method transfer, method verification and method validation under appropriate guidance, along with routine release and stability testing in support of clinical development and registration activities required for regulatory submissions. The Role
Perform technical review of client documents as required, including specification/validation reports/test methods/compliance reports, to perform gap analysis with respect to methods/instruments/procedures for completing methods transfers from client or third-party labs with guidance from supervisors/senior team members Analyze finished products, in-process materials, and raw materials according to assigned specifications, methods, and protocols in line with cGLP and cGMP; document, process, and report the data to support the team in a timely fashion Perform analyses to support testing using KF titrations, dissolutions, IR, UV spectroscopy, LC to perform dissolutions/assays/BU/CU, impurities, and data processing using Empower; document per applicable test methods/specifications/protocols with guidance from senior team members Use Empower software to create instrument/processing/report methods and perform online Empower calculations for assay/dissolutions/impurities; knowledge of TrackWise for managing deviations and investigations with guidance from supervisors/senior team members Troubleshoot and propose method improvement requirements during method feasibility work of client-supplied methods and during compendial method evaluation for assay, impurities, dissolution, etc., with guidance from supervisors/senior team members Perform or assist with method transfers, compendial verifications, or full method validations (forced degradation and calculating mass balance/peak purity to prove stability-indicating nature) per applicable guidances (USP, ICH Q2, etc.) and SOPs with guidance from the supervisors/senior team members Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols; escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members Other duties as assigned The Candidate
Bachelor's Degree in Chemistry, Pharmaceutical Sciences or Life Sciences is required; preferred major Analytical Chemistry At least one year of experience in the pharmaceutical industry and 1+ years of experience in analytical testing/research using HPLC/GC/UV, etc. Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, µg/mL, etc.), molarity, Beer's Law, reference standard purity on as is, anhydrous, or dry basis, etc. Basic understanding and knowledge of analytical chemistry and chromatographic techniques (e.g., LC/GC/dissolutions) and spectroscopic (e.g., UV) analysis Ability to understand and follow ICH guidelines (ICH Q1, Q2, Q3, etc.) including other regulatory guidelines Adhere to and perform all lab duties according to applicable SOPs related to safety, waste management and housekeeping; work with the team to improve processes and procedures Assist with lifting of liquid containers and objects greater than 50 lbs as required Why You Should Join Catalent
Several Employee Resource Groups focusing on D&I Tuition Reimbursement – let us help you finish your degree or earn a new one Generous 401K match 152 hours accrued PTO + 8 paid holidays Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Catalent is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired as a result of an unsolicited agency or search firm referral.
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