Downstream MS&T Manager

Downstream MS&T Manager

Bristol-Myers Squibb

Cruiserath, Ireland

BMS Cruiserath Biologics is seeking to recruit a permanent Downstream MS&T Manager. The Downstream MS&T Manager will lead a group of scientists that will be responsible for the design and execution of experiments in protein chromatography, viral inactivation, ultrafiltration/diafiltration, and filtration unit operations. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale and the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots.

Responsibilities will include (but not limited to):

  • Provides technical expertise for investigation and resolution of downstream process deviations, root cause investigation, CAPAs, process improvements, scale-down model development new technology evaluation, and preparation of regulatory filings;
  • Demonstrates a strong knowledge of cGMP compliance, site and regulatory agency requirements and procedures;
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Cruiserath Large Scale Cell Culture facility;
  • Participates in the preparation of regulatory filing documents and inspection readiness;
  • Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the Cruiserath site.

Qualifications and Experience required:

  • Minimum BS in the biological sciences or chemical/biochemical engineering or equivalent with a minimum 13 years relevant experience, MS or equivalent with minimum of 10 years relevant experience, Ph.D. in Scientific discipline with 4 years of relevant experience in downstream manufacturing technical support or downstream process development in the biopharmaceutical industry;
  • Proven experience in successful execution and management of process technical transfer;
  • Experience in the design, modification and optimization of biologics purification unit operations;
  • Proven project management skills that include leading cross functional teams and effectively balancing project assignments with other duties;
  • Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors;
  • Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams;
  • 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.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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