Quality - Senior Manager, EXM Quality Analytical - TechDigital
Devens, MA
About the Job
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
Education Required:
Bachelor's Degree required; General Sciences Preferred
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)
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
Education Required:
Bachelor's Degree required; General Sciences Preferred
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)
Source : TechDigital
