Our Client is a biotech company based in Waterford; they currently seek a Manager for the QTA group within the QC department.
The QTA Manager has a primary role in the delivering the site analytical development and capability enhancement programs, with a core focus on New Product Introduction and Analytical and Equipment Lifecycle Management and Remediation.
Accountabilities:
Accountable for delivering method transfers, Development to Validation, Assessment and Remediation
Establishes programs for New QC Technology evaluation and innovation.
Accountable for QC capital program delivery, assessing and implementing the technologies to stay current with state of the art and industry best practices
Accountable for delivering the analytical support of the NPI process.
Accountable for delivery of the site ALCM process
Enables QTA to provide analytical testing and knowledge support to wider internal and external customers
Manages team of QTA team leader(s), scientists, analysts and project managers to effectively deliver mandated programs
Manage QTA spend to Opex and Capex budget
Work with corporate partners to deliver analytical mandates and strategies.
Skills & Knowledge
Detailed knowledge of Biopharma analytical methodologies and technologies.
Effective technical knowledge of Biopharmaceutical manufacturing
Knowledge of requirements for cGLP, cGMP, pharmacopoeial methods and stability.
Ability to manage projects to plan/budget
Excellent & efficient communicator at organisation, team and individual levels
High energy, commitment and flexibility.
Ability to work independently and adapt.
Excellent leadership skills with ability to influence and affect change
Capable of resolving issues of conflict effectively within a team
Ability to understand the ‘broader picture’ and business context
Ability and willingness to identify opportunities to ‘break the mould’ with systems and processes
Requirements:
Degree in Science (Chemistry, Microbiology or Pharmacy preferred)
Post-graduate studies as appropriate to augment primary degree
+10 years in biopharma industry, with Operational experience of quality laboratories in a fast moving manufacturing environment and demonstrated project management experience.
Experience of analytical transfer programs and method development/validation
A proven track record in the ability to transfer goals and objectives into measurable plans.
Proven ability to manage high performing teams of scientists and analysts.
Package:
Contract rate dependent on prior experience
Contract duration: Minimum 12 months
Contact:
Karen McHugh is the consultant managing this Job Description
Our Client is a biotech company based in Waterford; they currently seek a Manager for the QTA group within the QC department.
The QTA Manager has a primary role in the delivering the site analytical development and capability enhancement programs, with a core focus on New Product Introduction and Analytical and Equipment Lifecycle Management and Remediation.
Accountabilities:
Accountable for delivering method transfers, Development to Validation, Assessment and Remediation
Establishes programs for New QC Technology evaluation and innovation.
Accountable for QC capital program delivery, assessing and implementing the technologies to stay current with state of the art and industry best practices
Accountable for delivering the analytical support of the NPI process.
Accountable for delivery of the site ALCM process
Enables QTA to provide analytical testing and knowledge support to wider internal and external customers
Manages team of QTA team leader(s), scientists, analysts and project managers to effectively deliver mandated programs
Manage QTA spend to Opex and Capex budget
Work with corporate partners to deliver analytical mandates and strategies.
Skills & Knowledge
Detailed knowledge of Biopharma analytical methodologies and technologies.
Effective technical knowledge of Biopharmaceutical manufacturing
Knowledge of requirements for cGLP, cGMP, pharmacopoeial methods and stability.
Ability to manage projects to plan/budget
Excellent & efficient communicator at organisation, team and individual levels
High energy, commitment and flexibility.
Ability to work independently and adapt.
Excellent leadership skills with ability to influence and affect change
Capable of resolving issues of conflict effectively within a team
Ability to understand the ‘broader picture’ and business context
Ability and willingness to identify opportunities to ‘break the mould’ with systems and processes
Requirements:
Degree in Science (Chemistry, Microbiology or Pharmacy preferred)
Post-graduate studies as appropriate to augment primary degree
+10 years in biopharma industry, with Operational experience of quality laboratories in a fast moving manufacturing environment and demonstrated project management experience.
Experience of analytical transfer programs and method development/validation
A proven track record in the ability to transfer goals and objectives into measurable plans.
Proven ability to manage high performing teams of scientists and analysts.
Package:
Contract rate dependent on prior experience
Contract duration: Minimum 12 months
Contact:
Karen McHugh is the consultant managing this
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical