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Catalent · 8 hours ago

Associate Scientist

Winchester, KY

Full-time

Onsite

Entry Level

1+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to helping people live better and healthier lives. The Associate Scientist is responsible for performing analytical research and development work, including method development, transfer, verification, and validation to support clinical development and regulatory submissions.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Perform 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, report the data as applicable to support the team in 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. 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

Qualification

HPLCGCUV spectrophotometryAnalytical ChemistryICH guidelinesTeam collaborationProblem-solvingAttention to detail

Required

Bachelor's Degree in Chemistry, Pharmaceutical Sciences or Life Sciences is required, preferred major 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. is required

Basic understanding and knowledge of analytical chemistry and chromatographic techniques (e.g., LC/GC/dissolutions) and spectroscopic (e.g., UV) analysis is required

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 is required

Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs. is required

Benefits

Tuition Reimbursement – Let us help you finish your degree or earn a new one!

Generous 401K match

152 hours accrued PTO + 8 paid holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

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