Catalent
Associate Scientist
Catalent, Winchester, Kentucky, us, 40392
Associate ScientistPosition SummaryCatalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.Catalent’s Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers, and commercial manufacturing, and roots in industry-leading Glatt technology.The Associate Scientist is responsible for performing analytical research and development work in the Analytical R&D Department. The Associate Scientist will assist 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 the regulatory submissions.Monday-Friday 8 AM-5 PMThe RolePerform technical review of client's documents as required including but not limited to specification/validation reports/test methods/compliance reports etc. to perform gap analysis with respect to methods/instruments/procedures etc. for completing methods transfers from client's/or their third-party labs with guidance from supervisors/senior team members.
Analysis of finished products, in-process materials, raw materials, according to the assigned specifications, methods, and protocols according to cGLP and cGMP. Document, process, and report the data as applicable to support the team in a timely fashion.
Perform analysis as required to support assigned testing using KF titrations/Dissolutions/IR/UV spectrophotometers, LC to perform dissolutions/assays/BU/CU, impurities, and data processing using Empower and document per applicable test methods/specification/protocols etc. with guidance from senior team members.
Use Empower software- creating instrument/processing/report methods and performing online empower calculations for assay/dissolutions/impurities etc. Knowledge of Trackwise for managing deviations and investigations and ability to manage/handle with guidance from supervisors/senior team members.
Troubleshoot and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members.
Perform/assist team members in method transfers, Compendial verifications, or full method validations (forced degradation and calculating mass balance/peak purity to prove stability indicating nature of the method) per applicable guidances (USP, ICH Q2 etc.)/SOPs with guidance from the supervisors/senior team members.
Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols and report/document per applicable specification/stability protocols. Escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members.
Other duties as assigned.
The CandidateBachelors Degree in Chemistry, Pharmaceutical Sciences or Life Sciences Required (Preferred in Analytical Chemistry)
Must have at least one year of experience in pharmaceutical industry and 1+ years of experience in analytical testing/research experience 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.
Demonstrate knowledge and ability to understand and follow ICH guidelines (ICH Q1, Q2, Q3 etc.) including other regulatory guidelines.
Adhere and perform all lab job duties/responsibilities according to applicable SOP's related to DEA scheduled drugs, safety, waste management and housekeeping and work with the team in improvement of the processes and procedures.
Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.
Maintaining clean environment for laboratory operations.
Use of and safe handling of glass canisters, chemicals, and other required equipment.
Why You Should Join CatalentSeveral 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 offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Visit
Catalent Careers
to explore career opportunities.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.
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Analysis of finished products, in-process materials, raw materials, according to the assigned specifications, methods, and protocols according to cGLP and cGMP. Document, process, and report the data as applicable to support the team in a timely fashion.
Perform analysis as required to support assigned testing using KF titrations/Dissolutions/IR/UV spectrophotometers, LC to perform dissolutions/assays/BU/CU, impurities, and data processing using Empower and document per applicable test methods/specification/protocols etc. with guidance from senior team members.
Use Empower software- creating instrument/processing/report methods and performing online empower calculations for assay/dissolutions/impurities etc. Knowledge of Trackwise for managing deviations and investigations and ability to manage/handle with guidance from supervisors/senior team members.
Troubleshoot and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc. with guidance from supervisors/senior team members.
Perform/assist team members in method transfers, Compendial verifications, or full method validations (forced degradation and calculating mass balance/peak purity to prove stability indicating nature of the method) per applicable guidances (USP, ICH Q2 etc.)/SOPs with guidance from the supervisors/senior team members.
Perform stability testing on developmental/clinical/registration batches as per approved test methods/stability protocols and report/document per applicable specification/stability protocols. Escalate any OOS/OOT/atypical/trending results with supervisors or concerned team members.
Other duties as assigned.
The CandidateBachelors Degree in Chemistry, Pharmaceutical Sciences or Life Sciences Required (Preferred in Analytical Chemistry)
Must have at least one year of experience in pharmaceutical industry and 1+ years of experience in analytical testing/research experience 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.
Demonstrate knowledge and ability to understand and follow ICH guidelines (ICH Q1, Q2, Q3 etc.) including other regulatory guidelines.
Adhere and perform all lab job duties/responsibilities according to applicable SOP's related to DEA scheduled drugs, safety, waste management and housekeeping and work with the team in improvement of the processes and procedures.
Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs.
Maintaining clean environment for laboratory operations.
Use of and safe handling of glass canisters, chemicals, and other required equipment.
Why You Should Join CatalentSeveral 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 offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Visit
Catalent Careers
to explore career opportunities.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.
#J-18808-Ljbffr