Technology Transfer Specialist
The successful candidate will be a member of the Manufacturing Operations team, reporting to the Technology Transfer Lead. You will be responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
The Technology Transfer Specialist role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working.
* Developing a tech transfer program that supports the manufacturing operations team.
* Collaborating with the team and stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
* Maintaining and feeding information delivered from Development in different digital tools such as COMET SAP, MES, and DeltaV.
* Managing new program introduction schedules to ensure tasks are executed on schedule and right-first time.
* Representing the Technology Transfer function in various teams.
Key Responsibilities:
* Servicing small projects with moderate resource requirements, risk, and/or complexity.
* Supporting the development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Designing and implementing best practices in tech transfer.
* Assisting in the development of future breakthrough business solutions, reducing overall effort/risk, optimizing them for rapid product launch.
* Providing feedback and proposing opportunities for optimization to current Tech Transfer processes.
* Writing, maintaining BOMs (Bill of material), EBRs (Paper), gBMRs (MES), SOPs/WIs.
* Showing excellent troubleshooting and problem-solving skills, collaborating effectively within global and interdisciplinary teams.
* A commitment to continuous learning, improvement, and development, approaching problems from new perspectives.
* Supporting the aggregation of process-related knowledge for centralized management.
* Ensuring the highest Quality, Compliance, and Safety standards.
Requirements:
* A degree qualification in a relevant field (Science/Technical).
* Minimum of 3 years of work experience in the pharmaceutical or biotech industry.
* Fluent English (oral and written).
* Familiarity with Unit Operations for mAb manufacturing.
* Basic knowledge of project management.
* Competency in issuing/transcribing information into documents required for manufacturing, such as BOM, Batch Sheets, and DeltaV.
* Proficiency in automated/digital systems like DeltaV, MES, eVal, SAP COMET.
* Experience managing small projects with cross-functional groups.
* Working knowledge of cGMP regulations.
* Understanding of general principles of New Product Introduction (Tech Transfer).
Preferred Experience and Skills:
* Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, preferably with single-use systems experience.
* Practical problem-solving capabilities when analyzing complex situations.
* Familiarity with risk assessment processes.
* Familiarity with automation system usage in a manufacturing process.
* Ability to work effectively as part of a team and independently.