Upstream Tech Transfer Lead

Upstream Tech Transfer Lead

Remote

6-Month Contract

Brief

Upstream Tech Transfer Lead needed for a highly reputable Pharmaceutical organisation who are looking to employ an experienced and well-rounded Upstream Tech Transfer Lead that takes pride in their work with an in-depth knowledge of development using hands on cell culture experience with stirred tank bioreactors (stainless or single use), cell culture tech transfer and/or development experience and possess a fundamental understanding of upstream unit operations such as mixing, bioreactor, and filtration.

What the role entails:

Some of the main duties of the Upstream Tech Transfer Lead will include:

• Transfer and support assigned project(s) to CMO(s) as upstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support and deviation write ups, process validation documentation review/approval, campaign summary report authoring, and routine presentations to cross-functional teams and management
• Builds and maintains relationships with partner groups
• Proactively addresses risks/issues and influence partners/CMOs to avoid non-conformances and enable efficient transfers
• Represent function on cross-functional teams
• Participate in design or analysis of lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
• Write technical assessments and/or reports and deliver presentations

What experience you need to be the successful Upstream Tech Transfer Lead:

• Hands on cell culture experience with stirred tank bioreactors (Stainless or single use)
• Cell culture tech transfer and/or development experience
• Hands on or tech transfer experience to at least 200L scale or above
• Fundamental understanding of upstream unit operations such as mixing, bioreactor, and filtration.
• Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes
• Knowledge of GMP manufacturing principles and documentation
• Skilled in root cause analysis and problem-solving
• Demonstrated critical thinking skills
• Demonstrated technical writing
• Excellent written and verbal communication skills
• Sound decision making with limited data and guidance
• Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations using sound scientific reasoning
• Skilled in effectively explaining complex scientific or engineering concepts to a broad and diverse cross-functional audience.
• Experience with being an effective and influential contributor and leader to projects governed by matrix teams
• Ability to work in a fast-paced environment
• Demonstrated initiative and drive for results
• Demonstrated ability to stand in the face of strong/higher level opposition
• Must be able to work independently
• Experience with data and statistical analysis
• Proven experience in preparing detailed and thorough technical protocols and reports
• Knowledge of the drug development process, global regulations, process validation and ICH guidelines

This really is a fantastic opportunity for an Upstream Tech Transfer Lead to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

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