Technology Transfer Specialist in Lenoir, NC at APEX Systems

Date Posted: 6/25/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lenoir, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    6/25/2019

Job Description

Job #:  952791


Currently seeking an experienced candidate for a Technology Transfer Specialist in the Hickory, NC area.  Please contact Dave Hurt at dhurt@apexystems.com or Office: 980-938-7295  |  Mobile: 252-455-0423 
The Technology Transfer Specialist is responsible for activities related to process development and technology transfer for terminally sterilized and aseptically filled pharmaceutical products into vials, syringes and IV bag formats.
Job Responsibilities
This position will be primarily responsible for activities related to process development and technology transfer from R&D into production but also includes ongoing technical support for manufacturing. Specific responsibilities include but are not limited to the following:
  • Utilize quality by design (QbD) principles to ensure products under development (R&D) meet their critical quality attributes.
  • Interface with Operations, Regulatory and Quality Assurance and Quality Control departments to complete experimental/optimization trials and technology transfer of new and re-start products to production.
  • Development and coordination of related manufacturing transfer documentation
  • Standard Operating Procedure (SOP) and Specification creation and revisions
  • Investigation of Manufacturing Events
  • Performing Process & Engineering studies
  • Creating and updating documentation needed for Regulatory Submissions
  • Assists in the preparation and presentation of department KPI (Key Performance Indicators) through routine progress report updates to the management team.
  • Collaborate and communicate with other specialists and leaders to coordinate cross-project initiatives and activities.
  • Work with both internal and external resources to achieve technical business solutions within project guidelines.
  • Respond to operational issues and information requests within defined areas of responsibility while progressing on work assignments.

Education Requirements:
Bachelor’s degree required in physical science, engineering or equivalent. 3 to 5 years’ experience with product development, manufacturing, quality control, or product transfer assignments that demonstrates tenacity to see projects through to completion according to established action plan; analytical skills necessary for problem solving.
Additional Requirements:
  • 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.
  • Understanding of aseptic processing techniques.
  • Knowledge of pharmaceutical product development, manufacturing processes, validation, cGMP’s and FDA regulations for the Pharmaceutical Industry.

Experience Requirements
  • Working knowledge of Six Sigma and LEAN principles
  • Must have good analytical skills and be detail-oriented
  • Must be able to work as part of a team
  • Must have good leadership and communication skills
  • Proficiency in the use of:
    • Word processing
    • Data base management
    • Spreadsheets
    • Prior experience using Statistical software such as: JMP or Minitab is desired

 
 
 
 
 
 
 
 
EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.