FUJIFILM

QC Technical Supervisor

Job Locations US-NC-Research Triangle Park
Posted Date 2 months ago(5/10/2022 5:01 PM)
Requisition ID
2022-20059
Category
Quality Control
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies

Overview

Primary responsibilities of the QC Technical Supervisor will be to test complex and critical analytical chemistry/biochemistry assays (50% of time) and to supervise and coordinate staff performing analytical chemistry testing and the associated laboratories (50% of time) in support of processes and products manufactured at the RTP site. This individual will provide technical leadership to staff to support routine testing including HPLC, UPLC, SEC, CE, iCiEF, Peptide Mapping, DNA Threshold testing, pH, Appearance, Western Blot, ELISA, HCP and other biochemistry and analytical chemistry tests. The role will be a primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first-time data management and reporting, and assuring testing is completed in support of manufacturing timelines.

External US

Primary responsibilities of the QC Technical Supervisor will be to test complex and critical analytical chemistry/biochemistry assays (50% of time) and to supervise and coordinate staff performing analytical chemistry testing and the associated laboratories (50% of time) in support of processes and products manufactured at the RTP site. This individual will provide technical leadership to staff to support routine testing including HPLC, UPLC, SEC, CE, iCiEF, Peptide Mapping, DNA Threshold testing, pH, Appearance, Western Blot, ELISA, HCP and other biochemistry and analytical chemistry tests. The role will be a primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first-time data management and reporting, and assuring testing is completed in support of manufacturing timelines.

 

The technical supervisor will work alongside an operations supervisor or manager and be responsible for 4-9 reports that conduct analytical testing and generate critical data for drug substance batch release and stability reporting.  The aim, specifically of the technical supervisor, as opposed to more traditional people management positions is two-fold; 1) to provide an opportunity for first-time or early people managers to grow in the role while responsible for tasks/assays/labs in which they have increased breadth and depth of expertise and 2)  to provide a position that can focus on being a coach, trainer and mentor for relatively new analysts and moderately tenured analysts as they train, test, analyze data, report results, investigate exceptions and implement CAPAs/Changes.

The role will influence but be less responsible for outward facing responsibilities (interaction with clients, internal customers such as manufacturing) and department scheduling, planning and overall department direction, which are more generally the responsibility of the operations supervisor/manager.

 The successful candidate will be comfortable working in a fast-paced environment and is flexible, dependable and has the ability to work independently on a reduced but critical set of assays/assigned tasks relative to individual contributors while also managing reports.  The role requires the ability to perform highly critical and complex assays and tasks on a regular basis while also managing a small team of developing and performing analysts.

 

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Provides day to day technical testing and SME support for execution of methods, training, pre-task briefing, witnessing and troubleshooting
  • Supervises the testing of process intermediates, final products, and stability samples
  • Review and approves limited STAT-Tested data, new procedures and procedure revisions
  • Anticipates and responds to technical problems, coordinates investigations and develops appropriate CAPAs, assuring compliance is maintained and timelines are met
  • Evaluates and approves deviations/investigations reports
  • Assists in the hiring process for department staffing
  • Communicates department and personnel expectations
  • Conducts performance evaluations and provides constructive feedback to direct reports on an ongoing basis
  • Facilitates development and opportunities to direct staff
  • Assures staff if fully trained and immediately corrects gaps or deficiencies
  • Assures department safety and housekeeping activities are sustained
  • Identifies and implements process improvements
  • Assures overall laboratory is fit for purpose, compliant, and able to support manufacturing activities
  • Coordinates workflow by scheduling and assigning workloads

BACKGROUND REQUIREMENTS:

 

Required education and experience:

  • BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field and 5+ years related laboratory experience
  • Quality control experience in the pharmaceutical industry supporting cGMP areas
  • Experience providing technical oversight for Deviation, CAPA and OOS investigations in a QC environment
  • Expertise in Chromatography and specifically, Empower Analytical Software

Desired Qualifications and Skills:

  • Demonstrated subject matter expertise in several key QC disciplines (LC, CE, Peptide Mapping, iCiEF, SEC)
  • Must possess strong organizational skills and a demonstrated ability to be self-directed while managing multiple projects.
  • Demonstrated Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
  • Must have excellent collaboration skills with colleagues both within and outside of the department
  • Must possess effective communication and technical writing skills
  • Capable of coordinating activities and tasks in a high through-put and high quality, RFT environment
  • Effective listening and coaching skills
  • Strong attention to detail.
  • Expertise with Labware LIMS and/or Softmax Pro is a plus.
  • Experience in maintaining safe, orderly, inventories and efficient laboratories
  • Success as a trainer of complex analytical disciplines
  • Demonstrated ability to establish and perform-to key indicators in a lab environment (Adherence to on-testing schedule, High Right-the-First-Time execution and delivery of low-error documentation for review
  • Root Cause Analysis or other Investigation Training

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

 

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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