Manager, Process Validation

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Manager, Process Validation report directly to the Director, Manufacturing Sciences and Technology at FUJIFILM Diosynth Biotechnologies. The job holder will oversee the development and implementation of validation strategies, policies, and protocol. They will perform analysis and compilation and data and results into final reports.

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

The Manager, Process Validation will lead and oversee the site validation team responsible for the qualification of processes used to manufacture GMP clinical and commercial products in compliance with GMP regulations.  The Manager will work closely with process development and tech transfer groups to transfer processes from clinical to commercial phases.

Reports to                Director, Manufacturing Sciences and Technology

Work Location         Thousand Oaks, CA 

Travel                         Travel required (Up to 10%)

Primary Responsibilities:

• Technical subject matter expert for process validation. Maintains departmental expertise in process validation and related activities.
• Oversee development and implementation of validation strategies, policies, protocols, and other documentation for process validations
• Supervise staff and validation contractors in the planning and execution of validation activities.
• Review and approve validation documents generated by team.
• Develop and execute validation plans and protocols to demonstrate process are meeting requirements.
• Perform analysis and compilation of data and results into final reports.
• Organize and execute the aseptic process verification (media simulation) program.
• Review/assess proposed validated process changes via Change Control to identify requirements necessary to maintain validated status.
• Investigate process issues and perform root cause analysis and implement solutions.
• As a subject matter expert, represent these activities in discussions and communications with regulatory agencies (e.g., strategizing and preparation of regulatory submissions and in response to agency questions, as well as during facility inspections). 
• Interface with other departments (e.g., IT, Engineering, Facilities, Manufacturing, Quality Control and Quality Assurance) to ensure achievement of objectives relating to validation and associated activities, including compliance with all applicable standards.

Qualifications

• Bachelor's Degree preferred, in Biochemistry, Microbiology, Molecular and Cellular Biology, or Biology.
• 8+ years of experience or an equivalent combination of education and experience.
• 1+ years of supervisory/personnel management experience.
• Broad validation experience in the biopharmaceutical industry supporting cGMP facilities, including process validation.
• Experience leading projects with history of achieving results and outstanding outcomes.
• Direct experience participating in and supporting regulatory inspections and submissions.
• Experience with Aseptic processing and filling equipment.
• Proven experience managing teams.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.
• Strong conflict resolution and negotiation skills required.
• Proven project management skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Excellent verbal and written communication skills; good interpersonal skills.
• Independently represent the MSAT organization in a wide assortment of situations.
• Flexibility to travel as required to accommodate business needs.
• Able to work in controlled manufacturing environments requiring special gowning.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Join us!  FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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.