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Manager QC Bioanalytics

Title : Manager QC Bioanalytics profile
Sector : Scientific & Laboratory
Location : Limerick
Reference : CW121456
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

MANAGER QC BIOANALYTICS required by CareerWise Recruitment for our BioTech client in Limerick. The MANAGER QC BIOANALYTICS will oversee the laboratory quality control testing of in-process, stability and final drug products and will have technical responsibility for all bioanalytical aspects of QC testing.

Role of this position

  • Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Manages product testing to ensure efficient and compliant operations.
  • Reviews test reports.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
  • Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation
  • Track and monitor timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Special projects as assigned.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback and performance evaluations.

JOB REQUIREMENTS

  • BS in chemistry, biology or related field with 7+ years' relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years' experience in a supervisory/leadership capacity.
  • Thorough understanding of bioanalytical techniques in a cGMP environment.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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Careerwise Recruitment



Manager QC Bioanalytics

Title : Manager QC Bioanalytics profile
Sector : Scientific & Laboratory
Location : Limerick
Reference : CW121456
Contact : Conor Twomey
Office : Shannon
Tel : +353 21 4297422
Email : ctwomey@careerwise.ie

Job Description

MANAGER QC BIOANALYTICS required by CareerWise Recruitment for our BioTech client in Limerick. The MANAGER QC BIOANALYTICS will oversee the laboratory quality control testing of in-process, stability and final drug products and will have technical responsibility for all bioanalytical aspects of QC testing.

Role of this position

  • Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.
  • Manages QC Analysts, distributes work load, and monitors progress.
  • Manages product testing to ensure efficient and compliant operations.
  • Reviews test reports.
  • Ensures QC Analysts receive proper training.
  • Attends meetings to keep informed of manufacturing priorities.
  • Ensures that safety standards are maintained.
  • Ensures compliance with applicable cGMP regulations and SOPs.
  • Investigates atypical and OOS test results as necessary.
  • Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
  • Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
  • Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation
  • Track and monitor timeline of analytical validation projects.
  • Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Special projects as assigned.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback and performance evaluations.

JOB REQUIREMENTS

  • BS in chemistry, biology or related field with 7+ years' relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years' experience in a supervisory/leadership capacity.
  • Thorough understanding of bioanalytical techniques in a cGMP environment.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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