QC Materials Supervisor

Qlty Assurance Methods

icon-location-marker Cruiserath - IE
Posted 7 days ago Full_time R1517637

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Cruiserath Biologics are seeking to recruit a permanent QC Materials Supervisor to manage the Raw Material testing team within the QC Site Operations Team at its Multi-Product Cell Culture Drug Substance Facility.  Reporting to the QC Manager, they will supervise a team of QC Raw Material and Sample Management Analysts supporting site activities related to Utility Monitoring, Raw Material testing and management of Drug Substance and Drug Product samples.

The main responsibilities for this position include:

  • Responsibility for QC Raw Material Testing (Including Clean Utilities) and associated test and laboratory documentation.
  • Responsibility for technical transfer activities, coordinating all lab activities pertaining to successful completion of transfer projects
  • Compliance with Standard Operating Procedures and Registered Specifications.
  • Supervision of laboratory personnel and adjustments to schedules to maximise efficiencies and adequately support production and other departments.
  • Provide an effective and efficient QC Service to operations by supervising, developing and coaching the QC team.
  • Ensure timely completions on investigations, non-conformances and environmental monitoring and identify laboratory practices and procedures for further development / improvement.
  • Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
  • Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
  • Participate in regulatory agency inspections as required.
  • Conduct performance appraisal reviews for laboratory colleagues.
  • Monitor and assist staff with work progress.
  • Plan and implement procedures and systems to maximise operating efficiency.

Qualifications, Knowledge and Skills Required:

  • The successful candidate must demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions.
  • Experience in cross-functional teams and knowledge of applicable regulatory inspections is desirable.
  • The ideal candidate should hold a minimum of a third level qualification (Degree) in Chemistry or related discipline along with 4 years of experience in a pharmaceutical / healthcare laboratory or related technical function with at least 2 years of supervisory experience.
  • A Strong background in Raw Materials, technical transfers is required.

Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level. The BMS Behaviours are: Passion, Innovation, Accountability and Speed.

·        Passion: We pursue excellence to help patients prevail.

·        Innovation: We embrace new ideas.

·        Accountability: We own our outcomes and the outcomes of others.

·        Speed: We act with urgency and agility.

Why should you apply:

  • You will help patients in their fight against serious diseases.
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days,  life assurance and gain-sharing bonus.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.