Upstream Process Tech Transfer Lead, AstraZeneca

Job description
Astra Zeneca has an opening for a USP TT Lead consulting position (position based out of Gaithersburg MD in US, or Cambridge, UK but would work remotely from current location). We are seeking a highly motivated and experienced upstream tech transfer and manufacturing support professional. This position will be responsible for transfer of upstream processes from development into clinical/commercial manufacturing at CMOs. The position resides within the Cell Culture and Fermentation Sciences (CCFS) department (within Research and Development). Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), Operations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production. 

Responsibilities
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


Qualifications
Required Skills:
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


Desirable Skills:
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 conducting complex transfer/process development/technology development projects Supervision This position will not have any direct supervisory responsibilities.


Experience:
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). Position requires periodic weekend work and/or periodic late night work.
Position may require supporting sites in different time zones.
Position may require some travel to CMO or other sites (domestic and international).

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-04-11, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information, please contact Sara Kuikka sara.kuikka@randstad.se or Eleonor Ehrman +46733434109

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!