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Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Downstream MS&T Manager (LOA007893)

Reference:A007893 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

The Role
This Biologics company 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.

Key Duties and Responsibilities:

  • Recruits, manages, develops and mentors a high-performing team of scientists with a vision of maintaining industry scientific standards
  • Invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring and recognition.
  • Oversees theoperations of the downstream MS&T team involved in the process optimization, characterization and troubleshooting for manufacturing processes.
  • Contributes to the optimization and continuous improvement in manufacturing processes in alignment with regulatory and commercial manufacturing requirements
  • 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 and participates in inspection readiness.
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Large Scale Cell Culture facility.

Qualifications,Knowledge and Skills Required:

  • The successful candidate must possess a science or engineering degree in the biotechnology, biochemical, chemical or related disciplines, along with experience in commercial biologics manufacturing PhD (>6yrs), MS (>8yrs), BS (>10yrs), documented by a solid history of technical accomplishments. A strong practical knowledge of the technologies related to therapeutic protein purification and process engineering is essential.
  • Proven managerial skills in building high performing teams through effective resource planning and execution are essential, as well as highly effective leadership skills and capabilities are required for this position.
  • 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.
  • 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