Manager, DPFG MSAT

Fujifilm•Holly Springs, NC

6d•Onsite

About The Position

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.

Requirements

Bachelor’s 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

Nice To Haves

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

Responsibilities

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 CAPA's
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