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Manufacturing Manager - Technical Operations - Gene Therapy & Vaccine Mfg.

FUJIFILM Diosynth Biotechnologies
College Station, TX
Start date
Sep 21, 2022

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Job Details

  Manager, Technical Operations – Gene Therapy and Vaccine Manufacturing is an integral management position overseeing the Technical Operations team.

The Technical Operation team will provide Process/Manufacturing Technology expertise to the manufacturing organization to support:

  • Customer Program Fit Assessments
  • Technical Transfer from PD to Manufacturing
  • Equipment SME support
  • Manufacturing excellence
  • Technical support for trouble shooting
  • Technical training


It is expected that members of the Technical Operations team will have a strong background in Process/Equipment Engineering or GMP Bio Pharmaceutical Manufacturing experience.

External US


  • Management of the Technical Operations team
  • Leadership and building teams to support client and regulatory agencies in face-to-face interactions
  • Ownership of methodologies and support packages
  • Interface with internal / external technical experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact on the biopharmaceutical businesses enabling technology options to be identified, evaluated, and compared
  • Manage and lead the transfer of new processes and technologies to the National Center for Therapeutics Manufacturing and the Flexible Biomanufacturing Facility, ensuring requirements for health and safety and cGMP compliance are delivered
  • Ensure best practice operating methods are deployed by providing System Ownership
  • Participate in the resolution of operational problems such as deviations / QIPs / CAPAs by acting as System Owner
  • Ensure implementation of e-learning, video, classroom and in suite design and delivery as appropriate
  • All other duties as may be assigned or required


Special Features


Ensure the Technical Operations team works independently and with colleagues to provide expertise and assistance for the design, development, standardization and maintenance of operational biotechnology utilized in the manufacture of proteins, drug substances and gene therapies.


As a CDMO, customer liaison is a vital part of our business; the Technical Operations team will act as the point contact for our customers during manufacturing execution.


This leadership position will ensure the team becomes the subject matter experts on a set of the core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.


Team Objectives:

Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach including:

  • (Man) Develop and deliver effective skill building and training plans for a given operational technology to manufacturing technicians
    • Collaborate with individuals and teams of technicians & managers on self-development plans
    • Implement e-learning, video, classroom and in suite design and delivery as appropriate
    • Create and maintain the technical training manuals and personnel certification process
    • Assure local operational practice reflect local procedure and instruction
    • Provide guidance and direction on cross-functional training initiatives
  • (Materials) Understand process control and material inputs to ensure capable and acceptable process output
  • (Machinery) Understand technology operation capabilities, limits and control strategies
    • Review and/or Approve equipment qualification limits
    • Review Calibration Tolerances and Approve Out of Tolerance Investigations
    • Represent the manufacturing unit for equipment purchase, new technology and changes to equipment
  • (Methods) Develop and maintain Technical Operational Manuals/Standard Operating Procedures/Work Instructions/Batch Records
    • Lead operational technology standardization, standard batch templates and instruction interfaces and lead continuous improvement for a given technology
    • Interface with Process Development to ensure smooth transfer of processes into the manufacturing plant
    • Develop and approve procedures and batch records


Required Skills & Abilities:

  • Demonstrated leadership ability with proven communication success
  • Excellent oral and written communication skills, interpersonal and organizational skills
  • Must be willing to travel during startup phase, FDB site visitations will be essential to transfer improvements
  • Ability to train others to perform to cGMP standards
  • Proficient with Microsoft Office applications
  • Good self-discipline and attention to detail
  • Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required
  • Excellent math and computer skills
  • Experience working in cleanroom environments
  • Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities


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, some bending, stooping, pushing, pulling, reaching above shoulders and stretching
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
  • Lift up to 25 pounds frequently and up to 50 pounds, on occasion
  • Attendance is mandatory

Minimum Qualifications:

  • Master's degree preferably in Science, Engineering or other related field and four (4) years of relevant related experience including four (4) years of supervisory/management experience; OR
  • Bachelor's degree preferably in Science, Engineering or other related field and sic (6) years of relevant related experience including four (4) years of supervisory/management experience; OR
  • Associate's degree preferably in Science, Engineering or other related field and eight (8) years of relevant related experience including four (4) years of supervisory/management experience; OR
  • High school / GED in a related field and ten (10) years of relevant related experience including four (4) years of supervisory/management experience
  • Above experience must include four (4) years' GMP experience


Preferred Qualifications:

  • Experience in transfer of processes
  • Experience conducting and evaluating training
  • Experience with manufacturing instruments/equipment

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 email or call 979-431-3528.



FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.


Find Us
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
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