Manufacturing Director - FBF 200
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: June 25, 2022
Overview Summary: - The Manufacturing Director is responsible
for the planning, directing, and coordinating activities related to
the manufacturing processes for the start-up of the new Flexible
BioManufacturing Facility - 200 (FBF - 200) while maintaining a
highly effective operation leading to the production of safe,
efficacious and compliant therapeutics. - The Manufacturing
Director - FBF 200 will be responsible for the cGMP production,
manufacturing and systems that support the manufacture of
virus-related vaccines and biotherapeutic products in a BSL 2
state-of-art facility. External US Essential Functions:
- Directing and providing technical leadership for the overall
manufacturing operations for the viral vector products and
specialty drugs in FBF 200.
- Organizing, managing and improving manufacturing operations
activities in support of the development of new products or
processes and the manufacture of viral products according to cGMPs
in a timely manner.
- Ensuring the full compliance to OSHA and cGMP regulations of
the manufacturing operations at all times and working in concert
with QA, Engineering and Materials Management to ensure that the
manufacturing operations area is performing as required to meet
- Working with the Metrology, Engineering and Facilities groups
on site ensuring compliance and effectiveness through maintaining
appropriate Engineering standards, maintenance and calibration of
equipment according to all required standards.
- Direct manufacturing staff to ensure the timely delivery and
right first time execution of manufacturing operations for multiple
viral products in single rooms.
- Maintain the operational facility in the highest level of cGMP
compliance per FDA and customer expectations.
- Build, maintain and motivate a multi technology operations team
capable of achieving all productivity targets and output
requirements to service clients with products on time.
- Assist the Executive Leadership Team in establishing strategic
directions for manufacturing resources and activities for FBF 200,
and setting objectives to maximize the value of the
- Ensure continued operational efficiencies are realized with
reliable schedule adherence, lower conversion cost and increased
- Establish priorities and assure adequate resources to complete
projects in a timely manner.
- Provide technical direction and support to the Business
Development group by assisting in securing projects through
participation at customer meetings relating to all
- Represent the organizational unit as the prime internal and
external contact for FBF 200 site manufacturing operations.
- Complete investigations in a timely manner and ensure root
causes are correctly identified.
- Share responsibility for short and long term resources and
facility planning, and perform managerial duties as required, e.g.
budgets, personnel performance appraisals, etc.
- Work directly with Validation, Quality Assurance, Engineering,
and Project Management functional areas to plan and implement the
execution of cGMP activities in manufacturing operations for both
development processes and commercial operations.
- Monitor and report progress of projects within agreed upon time
lines, ensuring client and Company objectives are met.
- Responsible for participating and representing all
manufacturing operations in pre-approval inspections, FDA audits
and client audits.
- Develop and manage the budget requirements for each fiscal year
and organize the purchase of appropriate capital items as required
- Use Lean Six Sigma tools in day-to-day operations and to
improve the operation.
- Report manufacturing and quality performance on a regular
(i.e., monthly) basis through the use of various site metrics.
- Maintain adequate levels of materials in support of the
manufacturing organization while adhering to corporate inventory
- Act as the primary contact with Sales and Marketing, Internal
Planning and Research and Development in establishing a
consolidated production plan that defines inventory projects and
new production introductions.
- Develop manufacturing plan and establish procedures for
maintaining high standards of manufacturing operations to ensure
that products conform to established customer and company quality
- Formulate and recommend manufacturing policies and programs
that guide the organization in maintaining and improving its
competitive positions and the profitability of the operations.
- Direct and monitor department managers to accomplish goals of
the manufacturing plan, consistent with established manufacturing
and safety procedures. Act as a liaison between department
management/subordinate levels, as well as, executive
leadership/department manager levels to inform personnel of
communications, decisions, policies, and all matters that affect
their performance, attitudes, and results.
- Hire, train, develop and evaluate staff. Take corrective action
as necessary on a timely basis and in accordance with Company
policy. - Ensure compliance with current federal, state, and local
regulations in consultation with Human Resources as
- Perform other duties and projects as assigned and required.
-Required Skills & Abilities:
- Clear leadership qualities and demonstrated success in
management of change.
- Ability to coordinate, facilitate and organize resources.
- Ability to develop strategic relationships; strong verbal and
written communication skills; excellent presentation skills.
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- Ability to work effectively under extreme pressure to meet
- Well organized with ability to handle multiple activities
- Detail oriented and accurate.
- Excellent computer skills and proficient in MS Office (Word,
Excel, Outlook, PowerPoint).
- Strong interpersonal skills with an understanding of diverse
backgrounds and an emphasis on communication: training, team
building, negotiation skills, interdepartmental interactions,
leadership and supervision (motivation, directing) and management
(planning, budgeting, etc.)
- Ability to hire, train, and develop employees to grow within
the organization. -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 sitting, some bending, stooping and
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment is required.
- May be required to lift up to 40 pounds on occasion.
- Attendance is required.Supervisory Responsibilities:
- The following positions will directly report to the
Manufacturing Director: Production Manager Upstream, Production
Manager Downstream, and Manufacturing Support Manager. - Additional
supporting staff will also report into this position.Minimum
- Master's degree preferably in business, engineering, science,
or a related field with a minimum of 8 years' experience preferably
in Biotechnology or Pharmaceutical Operations with at least 6
years' experience in a managerial position; OR
- Bachelor's degree preferably in business, engineering, science
or a related field with a minimum of 10 years' experience
preferably in Biotechnology or Pharmaceutical Operations with at
least 6 years' experience in a managerial position; OR
- Associates degree minimum of 12 years' experience preferably in
Biotechnology or Pharmaceutical Operations with at least 6 years'
experience in a managerial position; OR
- High School diploma or equivalent with a minimum of 14 years'
experience preferably in Biotechnology or Pharmaceutical Operations
with at least 6 years' experience in a managerial position.
- Experience in GMP environmentPreferred Qualifications:
- Manufacturing in BSL 2 environment
- Experience in logistics/planning
- Lean Six Sigma - Black BeltWe 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 FDBTHR@fujifilm.com
or call 979-431-3528. -
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing Director - FBF 200, Executive , College Station, Texas
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