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Manufacturing Quality Analytical Manager

New Brunswick, NJ 08903

Posted: 05/08/2023 Job Number: 23838454

Job Description

Project Description:
  • Management of analytical tech transfer activities across API & Drug Product in an external manufacturing environment.
  • Provision of analytical expertise and troubleshooting support in the areas of API's and intermediates, drug products, raw materials, and Pharmacopoeia requirements in an external manufacturing environment.
  • Proactively manage all API & Drug Product Contract Laboratory Service (CLS) providers to Global External Manufacturing from a quality and compliance oversight perspective.
  • Engage with internal and external stakeholders to plan and manage the program for analytical method transfers from Client to CMOs or CMO to CMO.
  • Represent Global External Manufacturing as the QC laboratory subject matter expert in support of due diligence audits and for cause audits where laboratory related issues are a focus for such audits.
  • Review and approve all major laboratory investigations/OOS events at CMOs & CLS providers.
  • Provide technical support to the QP and Quality Operations Managers in relation to same.
  • Review and approve analytical change control documents associated with CMOs & CLS providers.
  • Facilitate and manage the communication flow to and from CMO analytical functions and global functions across Client such as Global Testing Standards, HQ.
  • Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences etc.
  • Review and approve analytical method validation documentation & activities at CMOs and CLS providers to determine compliance with ICH requirements and manage remediation of gap analysis at Client or CLS.
  • Provide analytical expert support for regulatory submissions.
  • Prepare, approve, and maintain the Quality Agreement with each CLS provider.
  • Establish and monitor an effective metrics program to measure the performance of the CLS providers.
  • Provide training to a wider External Manufacturing team.

Required Skills:
  • A minimum of a MBA in Chemistry or related discipline is also required together with a sound understanding of GMP & ICH guidelines.
  • In depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory.
  • API and Drug Product experience.
  • Strong knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills.
  • Project Management skills are required.
  • Strong technical knowledge of modern chromatographic methodologies.
  • Management of Third-Party relationships (desirable).
  • A minimum of 5 years' experience in a QC/QA environment is required for this role.
  • Ability to work independently and within team matrix environments.
  • Thorough knowledge of worldwide regulatory GMP requirements and a working knowledge of FDA & EU GMP requirements.
  • In-depth knowledge of Quality Management Systems relating to laboratory operations.
  • Ability to objectively critique investigation reports from third parties.
  • Good knowledge of API and Drug Product processes and ability to differentiate between requirements.

Please E-MAIL your resume (attachment to email) with rate and availability to Trez: trez@alphaconsulting.Com


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Esther (Trez)

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