Associate Director MS&T – Biologics

Associate Director MS&T (Tech Transfer) – Biologics

This innovative speciality biotech organisation is a leading science-based biopharmaceutical company based in the U.S that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. This organisation commercialises medicines for eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. Employing north of 4,000 staff globally with annual R&D spend of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally year on year.

The Position:

The Associate Director of Technology Transfer will work with the Manufacturing Sciences and Technology (MSAT) group. The Associate Director will lead a small team to provide technical guidance to the receiving facilities during the transfer process. The position will also focus on ensuring site to site consistency after the processes are successfully transferred. This role serves as a key conduit to partner organisations and will be responsible for ensuring strong relationships between manufacturing sites. This leadership position requires a strong technical background coupled with a dedication to developing and mentoring a team of technical leaders.
Additionally, the Associate Director will work in close collaboration with program management to define the technical deliverables required to successfully manage the process throughout the product life cycle for each commercial product. You will be required to:

  • Establish upstream, downstream and manufacturing technology capabilities to support biological drug substance production at internal and partner facilities.
  • Assess manufacturing requirements and capabilities prior to the transfer of new processes.
  • Support training of manufacturing personnel for both cell culture and purification operations across the manufacturing organisation.
  • Monitor the trending of process performance parameters against expectations.
  • Review process deviations to understand the possible causes from a scientific perspective and provide assessments of product impact.
  • Provide technical support for equipment and process validation activities.
  • Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
  • Ensure all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
  • Provide supervision, coaching, mentoring to direct reports and other manufacturing staff as required.

The Person

  • Requires a BSc degree in Life Sciences, Engineering or related field and 12+ years experience, or a PhD and 8+ years of experience in cell culture production or protein purification in a cGMP regulated environment.
  • Requires strong communication and problem solving skills, and 5+ years managing groups of senior level scientists or engineers.

To learn more, apply online or contact Shane Browne on +353 1 632 1865.

Salary: On Application Location: Dublin City Centre