Recruitment Consultant - Life Science and Engineering at Berkley Group
Specialist
The successful candidate would be responsible for supporting New Product Introduction, while also acting as a key contributor to the evolving site tech transfer strategy.
Senior Technology Transfer Specialist
The successful candidate would 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.
Responsibilities:
* Collaborate with stakeholders to identify and execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification).
* Lead tier meetings to coordinate activities between local and international groups for implementation of new Drug Substance manufacturing processes.
* Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
* Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, and process design documents. Improve local Tech Transfer procedures to streamline and standardize New Program Introduction ways of working, while remaining compliant with the Quality Manual.
* Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, to progress the team forward to "one-click" tech transfer.
* Embody Safe by Choice - know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
* Ensure the highest Quality, Compliance and Safety standards.
Basic Qualifications:
* Minimum of 5 years of work experience in the pharmaceutical or biotech industry.
* Bachelor's degree in: Biotechnology, Engineering, Chemistry, or related field.
* Experience with project management with cross-functional team members.
* Familiarity with upstream and/or downstream Unit Operations for mAb manufacturing.
* Competent in analyzing complex situations.
* Minimum of 3 years of experience with quality management and compliance systems.
* Understanding of the general principles of New Product Introduction (Tech Transfer).
* Familiarity with the use of Automation systems in a manufacturing Process.
* Competency in the use of automated/digital systems such as DeltaV, MES, eVal.
* Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
* Familiarity with risk assessment processes.
Seniority level: Entry level
Employment type: Contract
Job function: Supply Chain
Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr