Upstream Operations Manufacturing Project Lead

Company: FUJIFILM Diosynth Biotechnologies
Location: Holly Springs
Posted on: May 16, 2022

Job Description:

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. The Upstream Operations Manufacturing Project Lead acts as the upstream operations representative supporting the design and construction through to routine production operations. This individual will have some responsibility to hire, lead, and inspire manufacturing associates and supervisors during the project and into operations. External US ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide operational expertise required to ensure the facility is delivered on schedule, on budget, and in a state suitable to meet operational needs for the manufacturing organization with a focus on upstream operations.
• Approach problems with an open mindset facilitating transfer of processes from our existing facility, while leveraging your experience.
• Write, review, provide input, and/or approve P&IDs, URSs, Functional Specifications, procedure, and applicable process equipment design documents.
• Will be a key contributor and driver in preparation for operational readiness related to bulk drug substance manufacturing.
• Participate in equipment vendor FATs, SATs, and on-site commissioning.
• Lead and work with cross-functional groups to organize equipment startup and transfer into GMP manufacturing.
• Lead project change controls when necessary to ensure proper operation of equipment.
• Will have shared responsibility for staffing, training, instruction and management of manufacturing project and production teams.
• Ability to lead teams, facilitate workshops, coordinate effective communication and cooperation, and drive results to ensure operational readiness resulting in successful start-up and completion of the facility while moving into GMP operations. QUALIFICATIONS & REQUIREMENTS:
  • Experience in in manufacturing of biological products, familiar with GMP/GLP requirements.
  • Bachelor or Master or above degree in Pharmacy, Engineering, Biology, Chemistry, Life-Sciences etc.
  • 7+ years' experience from similar role in large pharma/biotech operations or projects.
  • 5+ years supervising teams or managing people.
  • Good communication skills and fluency in English
  • An effective leader with 5+ years leadership experience and a strong leader in developing and mentoring managers, team lead and junior staff members for both technical and leadership development.
  • Agility and flexibility as required in a project role where tasks and responsibilities are not limited by the group in which you reside or your documented job title or responsibilities.The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption. FDBN 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. FDBN 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 email . 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.

Keywords: FUJIFILM Diosynth Biotechnologies, Cary , Upstream Operations Manufacturing Project Lead, Other , Holly Springs, North Carolina