Upstream Process Tech Transfer Lead

Hobson Prior have an exciting new position to work for a fantastic leading pharmaceutical organisation on a contract basis. For more information, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role, you will be building and maintaining relationships with partner groups.
• You will be responsible for proactively addressing risks/issues and influence partners/CMOs to avoid non-conformances and enable efficient transfers.
• You will 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.
• You will be writing technical assessments and/or reports and deliver presentations.
• 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 organisations, 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.

Key Skills:

• Ability to work in a fast-paced environment.
• Outstanding written and verbal communication skills.
• Demonstrated initiative and drive for results.
• Highly skilled in root cause analysis and problem-solving.
• Demonstrated critical thinking skills.
• Demonstrated technical writing.
• Sound decision making with limited data and guidance.
• Demonstrated ability to stand in the face of strong/higher level opposition.
• Must be able to work independently.

Requirements:

• The ideal candidate will have a Bachelors, Masters or PhD Degree in an engineering or scientific discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.
• The candidate must have relevant industry related experience (BS 8+, MS 6+, PhD 6+ years).
• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory.
• Viral based production experience.
• Prior experience leading projects outside of area of technical expertise.
• 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.
• 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.
• Skilled in conducting complex transfer/process development/technology development projects.
• 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.
• Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations using sound scientific reasoning.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.