Technical Transfer Lead
Randstad is seeking a Technical Transfer Lead who will support the capacity expansions of a biotechnology facility in Bradley, Illinois. The person in this role will serve as the subject matter expert for the manufacturing processes utilized and provide ownership, direction and assurance for the technical transfer of new manufacturing processes to the site. The Technical Transfer Lead is responsible for ensuring the transferred processes are reflective of the current licensed processes or the stated 'To Be' design, resulting in successful startup and licensure. Expertise includes bulk and fill finish manufacturing processes, understanding of key and critical GMP manufacturing steps and parameters, process equipment and specifications and validation/qualification approaches.
--Serves as liaison with host facility (program team) to align manufacturing and validation/qualification initiatives.
--Develops technical transfer documentation required for FDA Type C Meetings and subsequent regulatory filings.
--Participates in meetings with US FDA and other regulatory agencies as required.
--Collaborates upon, reviews and approves facility and equipment user requirements and functional requirements specifications for alignment with technical transfer design.
--Is fully involved with the project team to support the generation of validation strategy documentation and provides review of validation project plans and master plans. Approves validation protocols as necessary.
--Serves as manufacturing subject matter expert regarding the host processes (and representatives) to assist in appropriate commissioning and qualification of facilities and equipment resulting in successful execution of conformance batch production.
--Supports the architectural and engineering design efforts to ensure the processes transferred are successful within design, construction, startup, validation, licensure and commercial operations.
--Supports and attends Factory Acceptance Testing events as required.
--Supports engineering and purchasing initiatives to develop RFPs.
Working hours: 7:00 AM - 3:30 PM
--Work effectively across time zone, geographic, functional and company boundaries, taking accountability for mutual success and continued development
--Excellent communication skills (both written and verbal)
--Passion and enthusiasm to drive change
--Excellent computer skills
--Proactive with a desire to "do"
--BA/BS in a scientific or technical discipline preferred.
--Minimum 5 years of pharmaceutical experience with proven project management or support skills.
--Excellent manufacturing process knowledge
--Thorough understanding of cGMP guidelines
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