Associate Director, Process Validation Sciences

Fujifilm

Posted on : 30-05-2025

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1 Vacancy

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Job Location

College Station, TX - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 30-05-2025

Job Description

Position Overview

The Associate Director Process Validation (PV) Sciences functions independently to support programs of high value and high regulatory significant through Process Validation studies. The role will lead the provision of scoping planning and execution of all Process Validation programs. As a key PV leader in the FDB organization the Associate Director plays a vital role in global harmonization of PV practices across the FDB network. The individual will work closely with internal and external customers to develop and maintain strong working relationships. The role will facilitate the establishment growth and maintenance of the Process Validation group at FDBT.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Job Title: Associate Director Process Validation Sciences

Reports to: Director Process Sciences

Essential Functions:

Individual will have considerable knowledge/expertise relevant to biologics manufacturing Process Validation such as:

Building and maintaining a team that has expert knowledge and experience of PV workflows including CQA and Scale Down Model establishment PPQ protocols and reports identification of CPPs through risk assessment approaches and development of experimental workplans and studies to identify CPPs and enable PPQ.
Provision of senior scientific input during proposal and scope development of late phase scopes of work.
Establish maintain and proactively improve systems of work that interface with other departments and allow consistent successful and efficient delivery of work packages.
Represent FDB externally at meetings and conferences including presenting Process Validation approaches which enhance the reputation of the business.
Effectively resolve conflicts and remove obstacles that stand in the way of accomplishing project goals and objects.
Participate in or lead projects as required on a range of Process Validation related deliverables.
Support the Business using expert knowledge during Audits.
Support/Lead PV implementation strategy for major local and global capital investments in Process Validation.
All other duties as may be assigned.

Required Skills & Abilities:

Operate in a highly regulated environment and maintain in-depth awareness of the regulatory background and expectations industry best practices and promote FDBs strategy to maintain compliance and competitiveness.
Develop and mentor junior scientists and engineers into more senior expert Process Validation personnel.
Embody the value of the organization leading by example with the highest standards of integrity.
Effectively communicates results of own work though scientific meetings presentations discussions and documentation.
The ability to work in team-oriented environment is essential as this person will work closely with multiple cross-functional group members and participate on multidisciplinary project teams.
Excellent verbal and written communication and interpersonal skills.
Exercises superior judgment and works independently with minimal supervision and/or guidance.
Must work well in a complex matrix management structure working with senior cross-site personnel and operational heads of Process Development and Manufacturing at all FDB sites.
Deep technical knowledge and extensive experience discussing complex technical data with customers.
Experience in cGMP and pilot scale biologics manufacturing equipment and practices and with the transfer of technology to cGMP operations.
Thorough understanding of regulatory requirements required for biologics approval.
Influencing skills are required to support clients at the most critical stage of their drug candidate journey.

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.
Attendance is mandatory.

Minimum Qualifications:

Ph.D. degree in Engineering Chemistry Biology or related field with at least six (6) years of relevant experience of which at least (8) years of management/supervisory experience; OR
Masters degree in Engineering Chemistry Biology or related field with at least ten (10) years of relevant experience of which at least (8) years of management/supervisory experience; OR
Bachelors degree in Engineering Chemistry Biology or related field with at least twelve (12) years of relevant experience of which at least (8) years of management/supervisory experience

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.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or ).

Required Experience:

Director

Employment Type

Unclear

Company Industry

Key Skills

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About Company

Fujifilm

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Associate Director, Process Validation Sciences

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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