Manager, DPFG MSAT

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Manager Drug Product Finished Goods (DPFG) MSAT is the process owner and focuses on DPFG manufacturing. This role sets up and maintains cGMP Aseptic operations and processes for integrating finished goods into the site. During the project phase leads projects and owns the technical transfer set up and initiation for DPFG. The Manager DPFG MSAT works closely with the commissioning qualification and validation (CQV) organization to ensure all equipment and processes are established and aligned leads projects to create new processes and expands the capabilities and functionalities into operations. This role supports the Global team providing subject matter expertise level inputs for drug product and finished goods group and ensures the business processes are in place.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

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

What Youll Do

Manages leads and develops a team of DPFG MSAT engineers and technical transfer associates
Manages a team to lead develop and implement scientifically sound and fit for purpose policies and procedures based on current regulations industry standards and industry practices for drug product manufacturing process and technology transfer and process validation
Provides cross-functional leadership/support to the manufacturing site to refine the process requirements for execution
Continuously seeks to optimize the manufacturing processes to ensure effective use of capacity and minimize costs
Partners with Client Program Design Quality Manufacturing and Engineering on platform development technology innovation scale-up and manufacturability as part of technology transfers as needed
Leads/supports assessments and recommends new equipment/platforms which improves manufacturing processes from a cost efficiency quality
and compliance perspective
Performs tech transfer stage gate reviews on incoming processes/changes to ensure the change is ready for introduction to Manufacturing ensuring
manufacturability of the process
As technical steward provide oversight for a robust technical transfer execution and manufacturing support throughout the production lifecycle of manufacturing processes
Supports the CMC review of regulatory submissions manufacturing site inspections and health authority inquiries
Provides team support for critical manufacturing investigations and technical oversight of deviations change controls and CAPAs
Resolves technical problems through scientific understanding and application of innovative solutions
Provides team support for investigations root cause analysis and optimization with data support and analysis
Leads team in curating critical knowledge and developing best practices in DPFG manufacturing
Coaches and mentors direct reports and team members to foster professional development and growth
Enforces and ensures team adheres to company policies and procedures
Evaluates team performance and address gaps appropriately
Administers company policies such as time off shift work and inclement weather that directly impact employees
Completes required administrative tasks (e.g. timecard approvals time off approvals expense reports etc.)
Coaches and guides direct reports to foster professional development
Participates in the recruitment process and retention strategies to attract and retain talent as needed
Addresses performance gaps employee questions and concerns and partners with HR as needed for resolution
Performs other duties as assigned

Minimum Requirements:

Bachelors degree in Life Sciences Engineering or related field with 10 years of CMC experience leading pre-approval and post-approval activities for biologic product including process development and/or GMP manufacturing
Prior DPFG development and manufacturing experience including process validation process transfer commercialization and manufacturing support and troubleshooting
2-3 years of Leadership experience leading teams projects programs or directing the allocation of resources

Preferred Requirements:

Masters degree in a scientific or engineering field
Previous drug product isolator start-up experience
Experience communicating and collaborating cross-functionally
Global Collaboration Experience

Working Conditions & Physical Requirements:

Ability to stand for prolonged periods of time up to 60 minutes
Ability to sit for prolonged periods of time up to 60 minutes

*#LI-Onsite

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 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 ().

Required Experience:

Manager

Position OverviewThe Manager Drug Product Finished Goods (DPFG) MSAT is the process owner and focuses on DPFG manufacturing. This role sets up and maintains cGMP Aseptic operations and processes for integrating finished goods into the site. During the project phase leads projects and owns the techni...