Senior Technology Transfer Leader
Posted on: September 19, 2023
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
- 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
- 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
- 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
- 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
- Minimum of a Bachelor's degree in science, engineering, or
- 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
- 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
Keywords: Yoh, Wilson , Senior Technology Transfer Leader, IT / Software / Systems , Wilson, North Carolina
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