The Manufacturing Science and Technology (MS&T) – Drug Product Technical Operations (DS Tech Ops) organization is seeking a highly motivated individual for a Technology Transfer position.
DP Tech Ops is accountable for technology transfers and commercial production of finished Drug Product at our Dundalk site.
This person will have the opportunity to participate in all areas of Tech Ops.
This may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and to provide support for process and capacity optimization.
Responsibilities include:
Work with Internal Partners to achieve business goals.
Provide support within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.
Responsible for process ownership, demonstrating technical excellence as the subject matter expert (SME) for drug product processes
Responsible for technical activities for the commercial manufacturing process, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
Responsible for technology transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
Provide on-site coverage in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations and Quality
Ensure that Site is inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Education Minimum Requirement:
Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Required Experience and Skills:
Minimum of 3 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
Strong communication in English and teamwork skills
Preferred Experience and Skills:
Proven expertise in aseptic operations, analytical testing, process development and tech transfer.
Knowledge of USP**** and industry/ regulatory requirements such as Annex 1 desirable
Experience with lyophilized products advantageous
Experience in start-up facility advantageous
Demonstrated ability to independently manage projects/work to schedule/deadlines
Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
Experience in deviation management and/or change control and/or equipment support and/or equipment qualification, and/or project management.
Skills:
Drug Product Annex 1 GMP Filling
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