Technology Transfer Leader

POSITION SUMMARY:
The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and I&D teams. The position is responsible for assisting with and/or coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumbent is also responsible for designing manufacturing processes of varying degrees of difficulty for new or modified products to ensure robust and reliable product design and manufacturing processes for commercial scale. This position plans, coordinates, and oversees the product life cycle which includes development, stability, product validation batches, and cleaning validation/verification studies. The incumbent will provide necessary leadership to organize project teams, define milestones, support gap analysis and assist in qualification and validation activities.

PRINCIPAL ACTIVITIES:
Oversee execution of new product technology transfer and cleaning projects ensuring they are completed on time, on budget and in a manner consistent with regulatory and quality requirements.
Communicates plant issues and tasks with the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches.
Coordinates the preparation of the manufacturing site for the manufacture of new products.
Assesses manufacturing processes using FMEA or other risk analysis method(s) and uses the results to design robust manufacturing processes.
Plant liaison for manufacturing processes to other departments/business unit/marketing unit outside of the plant.
Prepares master batch records and protocols for the manufacture of development, stability, and validation batches. Translates development findings into manufacturing processes.
Identifies and implements practices and procedures designed to provide robust manufacturing processes.
Provides information and documentation needed for regulatory submissions or responses as required.
Serves as the plant focal point for channeling all manufacturing related questions and issues for resolution.
Conducts scale-up evaluation and support
Provides technical assessment of changes in manufacturing through appropriate review of documentation and supporting data
Develops and executes necessary investigative studies and validation protocols as required
Reviews as required various technology transfer documentation with regulatory and other appropriate groups
Coordinates project requirements with outside customers and vendors as required
Coordinates, tracks and reports on routine departmental assignments such as project time tracking, APQRs schedules, Product Modernization and Continue Process Validation monitoring as required
Assist in the training of new employees to the Technology Transfer department
Provides first level of support and direction to departmental staff members as required
Where gaps exist – develops action plans to improve

REQUIREMENTS:
Minimum of a Bachelor’s degree in science, engineering, or equivalent experience
Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
Strong interpersonal skills; must be able to interact effectively at all levels of the company
Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities
3–5 years experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving issues as they arise
Technical Area of Expertise cGMP manufacturing, equipment and process engineering, quality, product formulation, filling and packaging, sterile manufacturing technique, warehousing, distribution, purchasing, contracting, financial, administrative and enterprise systems.

Pay ranges between $55-61/hr based on experience