Associate Director

CPL

Limerick

Job Title: Associate Director, Technology Transfer. Department: Manufacturing, Manufacturing Sciences and Technology. Summary: 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 our partner organizations 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 lifecycle for each commercial product. Essential Duties and Responsibilities include, but are not limited to, the following : 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 organization. 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. Adhere to all plant safety policies and procedures and proactively identify unsafe conditions. Provide supervision, coaching, mentoring to direct reports and other manufacturing staff as required. Education and Experience: Requires a BS 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. Knowledge and Skills: Demonstrated interpersonal, written, and oral communication skills. Solid knowledge of cGMP and other applicable regulations. Ability to effectively communicate issues and ideas with peers and with management. Experience in large scale cell culture production and purification. Ability to adapt to a quickly changing environment. Ability to facilitate meetings with cross functional teams. Ability to build effective working relationships throughout the organization. This job originally appeared on RecruitIreland.com.

2802 days ago