Quality - ExM Quality Analytical Manager

Senior Manager

Hybrid Role

New Brunswick NJ

Work Schedule : Mon - Fri, Business Hours

Business Unit / Department External Manufacturing Quality

Principle Objective of Position

This role is a development opportunity for 12 months to gain experience on the analytical testing aspects associated with Drug Substance and Drug Product manufacturing, working in an external manufacturing environment (with CMO's) within Virtual Plant Teams (VPT's). The ExM Quality Analytical Senior Manager will provide analytical support to the VPT's and act as the analytical lead on CMO Technical Transfer Projects.

Major Duties and Responsibilities

Provision of analytical expertise and troubleshooting support in the areas of biologics for the external manufacturing(ExM) environment

Act as analytical lead to project manage analytical aspects of technical transfers to CMO's

Engage with internal and external stakeholders to plan and manage all testing of biological products at contract manufacturing organizations (CMO's) and contract test laboratories (CTL's)

Review and approve all laboratory investigations / deviations / Out of Specification (OOS) events at CMO's and CTL's with support from method SME's, as required

Act as Lead Investigator on Client infinity record as required for major analytical related deviations

Review and approve analytical change controls from CMO's and CTL's and act as impact assessor on Client change controls linked to CMO and CTL testing

Raise Client change controls related to analytical changes at CMO's and CTL's as required

Manage the communication flow to and from CMO / CTL analytical functions and global functions across Client such as Global Testing Standards, RSCR - Reference Standards Management Team, Global Quality Analytical Science & Technology, Microbiology Centre of Excellence etc.

Ensure supply of reference standards and critical reagents needed for testing at CMO's and CTL's

Support internal and external audits as Quality Control (QC) laboratory subject matter expert

Liaison with Global Stability team for CMO stability program

Complete sample submission forms for testing at CTL's and monitor sample shipments, samples receipt, testing and release status at CTL's

Ensure review and approval of analytical method validation / transfer / verification documentation & activities at CMOs and CTLs to determine compliance with International Council of Harmonization (ICH) requirements and manage remediation of gap analysis at Client or CMO / CTL

Support the generation and review of sample plans, APQR's, Risk Assessments, Quality Agreements etc.

Support analytical aspects of regulatory submissions, as required

Support Procurement in Request for proposal (RFP) process

Experience / Knowledge :

Ability to work independently and within team matrix environments

Ability to manage teams associated with individual aspects of responsibilities

Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements

In depth knowledge of Quality Management Systems relating to laboratory operations

Ability to ensure objective critique of analytical investigation reports from CMOs or CTLs

Ability to manage business plus quality relationship with contract testing labs and support biological testing issues at CMOs

Previous experience in QC laboratory facing QA activities is highly desirable

Previous experience using electronic document and deviation management systems is desirable

Working knowledge of analytical technical transfers is desirable

Skills / Competencies :

In-depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory

Drug Substance 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. Knowledge of bioassay, peptide and size exclusion chromatographic methods a distinct advantage

Management of Third Party relationships (desirable)