Manager, Solution Prep

Overview

The Manager, Solution Prep manages all Solution Prep activities and ensures the effective use of resources within Solution Prep to meet manufacturing schedules while maintaining compliant operations.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Manage all Solution Prep activities and ensures the effective use of resources within Solution Prep to meet manufacturing schedules while maintaining compliant operations.
• Develop a detailed plan of Solution Prep daily activities that ensures that both upstream and downstream manufacturing schedules are met, and that minimizes waste.
• Ensure that Solution Prep follow cGMPs and meet appropriate regulatory requirements.
• Hire, develop and retain manufacturing supervisors and associates.
• Ensure that all Solution Prep personnel are trained on and comply with all required safety procedures.
• In coordination with HR, set objectives and conduct performance reviews for staff.
• Support Engineering and Validation projects impacting Solution Prep, including responsibility for execution of validation/qualification protocols.
• Support Marketing and Sales, Customer Project Management, etc. in developing preliminary manpower estimates and equipment requirements to allow accurate contract pricing for proposed project.
• Participate in preparing budgets for the Solution Prep area and ensure that group operates within budget.
• In cooperation with Manufacturing Sciences, Process Development, Quality, etc, look for opportunities to improve operations.

BACKGROUND REQUIREMENTS:

• Bachelor’s degree in a related scientific or engineering discipline and 5+ years industry experience (fermentation, cell culture, purification); or 7+ years related experience and/or training; or equivalent

• Strong knowledge and experience with cGMP.
• Able to challenge and motivate others to improve their performance; defines job responsibilities and expectations, sets objectives, and offers feedback and support; rewards and reinforces good performance; deals with poor performance, urges and supports improvement throughout the performance period
•  Proficiency in MS Office (Word, Excel, PowerPoint) 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

 

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.

 

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.