Senior Technology Transfer Leader

Company: Yoh
Location: Wilson
Posted on: September 19, 2023

Job Description:

Senior Technology Transfer Leader--needed for a contract opportunity with Yoh Scientific's client located in--Wilson, NC.--This position will work with the quality, manufacturing, engineering, and global R&D teams of a major--pharmaceutical company, and requires a--Bachelor's degree--in Science, Engineering or equivalent experience and 5+ years of experience in the biotechnology/pharmaceutical industry. Schedule is--full-time M-F (7am-8am start time, 8 hour shift)--and may require flexibility to work some evenings and overtime due to projects.--Key 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. Is expected to be responsible for those new projects with a high level of difficulty.
• 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.
• 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.
• 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:
  • 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.
  • Effective oral and written communication skill set. Requires proficient presentation and technical writing abilities.
  • 5-7 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.
  • Completed and passed requirements for greenbelt.
  • Knowledge of parenteral product development, manufacturing processes, validation, cGMP's and FDA regulations for the Pharmaceutical Industry.
  • Work under minimal supervision on all projects with various level of difficulty.
  • Typical work hours are the standard first shift, however execution of protocols will often require work on nights and weekends to meet the production schedule.
  • Flexibility with schedule is required.
  • Schedule based on a 40 hour work week with the number of hours per day flexible to support protocol execution and production schedule.Note: Any pay ranges displayed are estimations.-- Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.-- All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit--to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, Wilson , Senior Technology Transfer Leader, IT / Software / Systems , Wilson, North Carolina