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
Didn't find what you're looking for? Search again!
Loading more jobs...