FUJIFILM

Process Sciences - Associate Engineer - Material Transfer

Job Locations US-TX-College Station
Posted Date 3 months ago(9/9/2022 10:10 AM)
Requisition ID
2022-21384
Category
Process Sciences
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies

Overview

Summary:

 

The Material Transfer Associate is responsible for compiling, organizing and reviewing documents that summarize safety testing results and/or describe safety characteristics of select incoming materials. They are also responsible for performing the material entry evaluation, identify gaps and perform risk analysis when needed to complete the material induction process. In addition, the Material Transfer Associate will be working with internal and external stakeholders to complete the transfer of materials from the client(s) to FDB (Fujifilm Diosynth Biotechnologies) for supporting process development work and cGMP manufacturing activities by monitoring inventory and tracking incoming materials, especially biological materials. 

External US

Essential Functions:

 

  • Works with Quality, regulatory and other departments/stakeholders to update entry testing requirements as and when needed
  • Compiles and reviews material-related documentation provided by client to assess if material complies with FDBT entry testing requirements
  • Prepares material assessment forms and risk assessments as needed
  • May coordinate testing if transferred material is missing minimal required test(s)
  • Supports with the generation of item specification number for GMP material using FDB Quality systems
  • Monitors and ensures accuracy of material inventory and documents through the material transfer process
  • Research and compile biosafety information related to the material being transferred when needed
  • Educates and provides general advice to FDB and client staff on material transfer procedures and risk analysis
  • Prepares documents and correspondence on a broad range of issues relating to material transfer process
  • Oversees the development and maintenance of the material transfer database including entering information on active and inactive transfers
  • Effectively communicates with FDB staff and clients about the status of the biological material entry assessment
  • Provides training, guidance and advice on issues related to the process of transferring biological materials to FDB
  • Trains other employees as needed
  • Performs other related duties as assigned
  •  

Required Skills & Abilities:

 

  • Familiarity with, and the ability to follow established SOPs and adhere to cGMP
  • Science background with applicable work experience handling biological samples preferred
  • Basic knowledge of virology, cell culture and plasmid biology
  • Inventory control and cataloguing in a scientific environment
  • Sample management experience preferred
  • Strong communication, interpersonal and organizational skills
  • Ability to clearly communicate in writing and verbally with internal staff and clients
  • Detail oriented and accurate
  • Ability to multitask and prioritize work with little supervision
  • Knowledge of MS Office (Word, Excel, Outlook, PowerPoint)

 

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged standing, along with some bending, stooping, and stretching
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
  • Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials
  • Ability to lift 50 pounds on occasion and 25 pounds regularly
  • Ability to wear PPE
  • Attendance is mandatory

 

Minimum Qualifications (in addition to the required skill sets and abilities):

  • Master’s Degree in a science related field; OR
  • Bachelor’s Degree in a science related field with 1 year of relevant experience

 

 

Preferred Qualifications:

  • Experience in pharmaceutical or biotechnology industry or virology
  • Knowledge of governmental regulation and established procedures on biological material qualification
  • Degree in Chemistry, Biology, Life Sciences or related field
  • cGMP experience preferred but not required

 

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3528.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed