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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

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We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

ExM Quality Analytical Manager

Job Description

  • Location: New Brunswick, New Jersey
  • Type: Contract
  • Job #73182

Our client, a leading pharmaceutical company, is hiring an ExM Quality Analytical Manager on a contract basis.

Work Location

New Brunswick, NJ/Hybrid

Summary

• Provision of analytical expertise and troubleshooting support in the areas of biologics for the external manufacturing environment

• Engage with internal and external stakeholders to plan and manage all testing of biological products at CMOs and CTLs

• Represent Global External Manufacturing as the Quality Control (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

• Manage through team or individually review and approve all major laboratory investigations/Out of Specification (OOS) events at CMOs & CTLs. Provide technical support to the Qualified Person (QP)/ Responsible Person (RP) and Quality Operations in relation to same

• Review and approve analytical change control documents associated with CMOs & CTLs or ensure said activities are done through team structure.

• Manage the communication flow to and from CMO analytical functions and global functions across the corporation, such as Global Testing Standards, RSCR (HQ) Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences, etc.

• Ensure review and approval of analytical method validation documentation & activities at CMOs and CTLs to determine compliance with International Council of Harmonisation (ICH) requirements and manage remediation of gap analysis at the organization or CLS

• Provide analytical expert support for regulatory submissions

 

Required Knowledge/Skills/Qualifications

Education: Minimum B.A. or B.Sc. in life sciences

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 CLSs

• 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 GMP Drug Substance environment is desirable

 

Skills/Competencies:

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

• DS 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)

 

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