Tech Transfer Lead

Actalent•Wilson, NC

33d•$45 - $55•Onsite

About The Position

The Technology Transfer Leader is a subject matter expert in Manufacturing Operations who collaborates closely with quality, regulatory, manufacturing, engineering, and R&D teams. This role is responsible for coordinating the transfer and implementation of projects and technologies from development groups and customers to the manufacturing site. The position also designs manufacturing processes for new or modified products to ensure robust and reliable production at commercial scale. Responsibilities span the full product lifecycle, including development, stability, validation batches, and cleaning validation/verification studies.

Requirements

Bachelor's degree in science, engineering, or equivalent experience.
3-5 years of experience in product development, process scale-up, or technology transfer.
Strong interpersonal skills and ability to work effectively across all organizational levels.
Excellent oral and written communication skills, including technical writing and presentations.
Expertise in cGMP manufacturing, equipment and process engineering, quality, product formulation, sterile manufacturing, packaging, warehousing, distribution, purchasing, contracting, and enterprise systems.

Nice To Haves

Strong skills in change control, aseptic processes, quality assurance, process optimization, and process improvement.

Responsibilities

Lead the execution of new product technology transfer and cleaning projects, ensuring timely and compliant delivery.
Communicate plant-related issues and tasks to project teams, especially regarding scale-up, new equipment, validation, and batch manufacturing.
Prepare the manufacturing site for new product introduction.
Conduct risk assessments (e.g., FMEA) to design robust manufacturing processes.
Act as the plant liaison for manufacturing processes across departments and external units.
Draft master batch records and protocols for development, stability, and validation batches.
Translate development findings into scalable manufacturing processes.
Provide documentation for regulatory submissions and responses.
Serve as the primary contact for manufacturing-related inquiries and resolutions.
Support scale-up evaluations and technical assessments of manufacturing changes.
Assist with investigations, action plans, and material change requests.
Develop and execute validation protocols and investigative studies.
Review technology transfer documentation with regulatory and other stakeholders.
Coordinate with external customers and vendors as needed.
Track and report on departmental assignments (e.g., project time tracking, APQRs, product reviews).
Mentor new department employees and provide first-level support to team members.
Identify and address process gaps through action plans.