This job has expired

You will need to login before you can apply for a job.

Head of Process Science

Employer
FUJIFILM Diosynth Biotechnologies
Location
Holly Springs, NC
Start date
Aug 8, 2022

View more

Discipline
Engineering, Manufacturing & Production, Process
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC
You need to sign in or create an account to save a job.

Job Details

The Head of Process Science will establish and lead our Manufacturing Science, Program Management & Tech Transfer interfaces to drug development partners at our Holly Springs site.  This is a one-of-a-kind opportunity to develop and define the future business model of what will be the largest cell culture manufacturing site in North America.  This senior leader will be essential in driving our new customer base as well as ensuring complete end-to-end Process Development and Manufacturing Science as Drug Product capabilities are being built to form an entire Process Science team.  They will function as the key overall customer interface for new products, processes and changes from partners and programs.  All strategic, tactical and operational aspects of the group will support the bulk drug substances and ensure close collaboration with Manufacturing, Global Engineering & Facilities, Quality, Regulatory, CMC, Business Development and Tech Development in meeting the business objectives.  The Head of Process Science will collaborate closely with our Denmark location to ensure alignment across key areas and will have full accountability for adherence to cGMP requirements and regulations.  This role will be highly visible in our community and our industry, and presents a unique chance to build something extraordinary.   

External US

Success Factors



• Ability to act independently and influence decisions
• Excellent communication skills and ability to interact/collaborate cross-functionally
• Strong organizational and time management skills
• Customer service focused and strong conflict resolution skills
• Strong presentation and public speaking skills



Responsibilities



• Oversee all site related processes for Manufacturing Operations
• Develop and execute performance and organizational management for staff including Scientists, Engineers, Managers & Directors 
• Direct tactical and operational activities for process staff. Ensures personnel are adequately trained on processing activities and safety requirement to execute their roles per established procedures. 
• Manage customer relationship from the site and develop and build organization for handling interface including establishing the program team, tech transfer team and process development organization
• Develop capacity and resource assessments, including equipment capacities and resource planning and allocation to ensure adequate staffing to meet production schedules. 
• Provide leadership in environmental and safety compliance  
• Ensure implementation of safety programs in Process Science
• Support regulatory submissions and inspections
• Develop and maintain budget (expense and capital) for Drug Substance, Manufacturing Science and Program Management teams
• Perform budgetary tracking and decision making for department expenses and capital expenditures for the site
• Ensure review of batch records and resolution of manufacturing related issues for release of batches
• Ensure overall compliance with personnel and workplace safety standards



Requirements



• Bachelor's Degree in Science/Engineering field is required.  Master's Degree or PhD is preferred.  
• Minimum of 12 years' experience in Process Science for a pharmaceutical company or CDMO is required
• Experience working with biologics drug manufacturing is required
• Demonstrated track record of success and progressively increasing responsibilities throughout career is required
• Prior leadership experience is required



Preferred Experience



• Experience working for a large pharmaceutical or biotech company
• CDMO or other client-focused experience
• Global collaboration experience

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

FacebookTwitter

Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert