Sr. Technology Transfer Leader

Responsibilities

• 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.
• Project manages all projects related to new products, product modernization and all product transfers.
• Communicates as necessary with the various plant departments, other support departments, project team members, and own department.
• Authors master batch records and protocols for the manufacture of development, stability, and validation batches.
• Translates development findings into manufacturing processes.
• Identifies and implements best practices and procedures designed to provide robust manufacturing processes.
• Provides information and documentation needed for regulatory submissions or responses as required.
• Plant liaison for manufacturing processes to other departments within the site, other business units within the company, and marketing units.
• Serves as the plant point of contact for channeling all manufacturing related questions and issues for resolution.
• Technically assesses changes in manufacturing through appropriate review of documentation and testing results. Reports changes through risk assessments.
• Provides technical support for Investigations, Action Plans and Material Change Requests, etc. as required.
• Generate innovative solutions to solving difficult problems that may impact multiple disciplines.
• Advises management regarding appropriate action.
• Develops and executes necessary investigative studies and validation protocols as required.
• Reviews as required various technology transfer documentation with regulatory and other appropriate groups.
• Identifies project requirements and facilitates requirements with outside customers and vendors, as required.
• Project manages routine departmental assignments such as project time tracking, APQRs schedules, Product Modernization and Continue Process Validation monitoring as required.
• Aid in the training of new employees to the Technology Transfer department.
• Assist in providing first level of support and direction to departmental staff members as required.
• Technical reviewer for tables and protocols and final reports (as assigned by manager).
• Tracks and coordinates routine departmental tasks.
• Actively participates in leadership training.
• Serve as a designee in the absence of the Technology Transfer Manager.

Qualifications

Education: Bachelor's degree in a relevant field (e.g., Chemical Engineering, Biotechnology, Pharmaceutical Sciences) or equivalent work experience.

Experience: Minimum of 5 years of experience in a similar role, preferably in a pharmaceutical or biotech manufacturing environment.

Skills: Strong understanding of GMP regulations, proficiency in MS Office, ability to manage multiple projects simultaneously, strong problem-solving skills, and excellent communication and interpersonal skills.

Other: Must be able to travel up to 20% of the time.