Manufacturing Manager, Downstream
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 19, 2023
Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies
(FDB)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 FDB and help create the next
vaccine, cure, or gene 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 FDB call Genki.The Manager, Downstream is responsible for the
planning, directing, and coordinating activities related to the
Downstream manufacturing processes at the National Center
Therapeutics Manufacturing - NCTM while maintaining a highly
effective operation leading to the production of safe, efficacious
and compliant therapeutics. The Manager, Downstream will be
responsible for the cGMP production and Downstream manufacturing
operations. External US Essential Functions:
- Directing and providing leadership for the downstream
manufacturing operations at NCTM.
- Organizing, managing and improving downstream manufacturing
operations activities in support of the development of new products
or processes and the manufacture of clinical products according to
cGMPs in a timely manner.
- Ensuring the full compliance to OSHA and cGMP regulations of
the downstream manufacturing operations at all times and working in
concert with QA, Engineering and Materials Management to ensure
that the downstream manufacturing process is performing as required
to meet client commitments.
- Working with the Metrology, Engineering and Facilities groups
on site ensuring compliance and effectiveness through maintaining
appropriate Engineering standards, maintenance and calibration of
equipment according to all required standards.
- Direct Downstream manufacturing staff to ensure the timely
delivery and right first time execution of manufacturing operations
for multiple products in single rooms
- Maintain the Downstream processes at the highest level of cGMP
compliance per FDA and customer expectations.
- Build, maintain and motivate the downstream team in order to
achieve productivity targets and output requirements to service
clients with products on time.
- Assist the Manufacturing Director - NCTM and the Executive
Leadership Team in establishing strategic directions for downstream
manufacturing resources and activities, and setting objectives to
maximize the value of the organization.
- Ensure continued operational efficiencies for downstream
manufacturing are realized with reliable schedule adherence, lower
conversion cost and increased productivity.
- Establish priorities and assure adequate downstream resources
to complete projects in a timely manner.
- Complete investigations in a timely manner and ensure root
causes are correctly identified.
- Work directly with Validation, Quality Assurance, Engineering,
and Project Management functional areas to plan and implement the
execution of cGMP activities in downstream manufacturing
- Monitor and report progress of the downstream processes to
ensure FDBT meets the client and Company objectives.
- Participate in and represent downstream manufacturing
operations in pre-approval inspections, FDA audits and client
- Report Downstream manufacturing and quality performance to the
Manufacturing Director on a regular (i.e., monthly) basis through
the use of various site metrics.
- Maintain adequate levels of materials in support of the
downstream manufacturing processes while adhering to corporate
- Assist in developing downstream manufacturing plans and
procedures for maintaining high standards of downstream
manufacturing operations to ensure that products conform to
established customer and company quality standards.
- Formulate and recommend downstream manufacturing policies and
programs that guide the organization in maintaining and improving
its competitive positions and the profitability of the
- Direct and monitor team members to accomplish goals of the
downstream manufacturing plan, consistent with established
manufacturing and safety procedures.
- Hire, train, develop and evaluate downstream manufacturing
staff. Take corrective action as necessary on a timely basis and in
accordance with Company policy. Ensure compliance with current
federal, state, and local regulations in consultation with the
Manufacturing Director and Human Resources as appropriate.
- Perform other duties and projects as assigned and required.
Required Skills & Abilities:
- Strong leadership qualities and demonstrated success in
management of change.
- Ability to coordinate, facilitate and organize resources.
- Ability to develop strategic relationships; strong verbal and
written communication skills; excellent presentation skills.
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- Ability to work effectively under extreme pressure to meet
- Well organized with ability to handle multiple activities
- Detail oriented and accurate.
- Excellent computer skills and proficient in MS Office (Word,
Excel, Outlook, PowerPoint).
- Strong interpersonal skills with an understanding of diverse
backgrounds and an emphasis on communication: training, team
building, negotiation skills, interdepartmental interactions,
leadership and supervision (motivation, directing) and management
(planning, budgeting, etc.)
- Ability to hire, train, and develop employees to grow within
the organization.Working Conditions & Physical Requirements:The
physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
functions. While performing the duties of this job, the employee is
regularly required to:
- Experience prolonged sitting, some bending, stooping and
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment is required.
- May be required to lift up to 40 pounds on occasion.
- Attendance is required. Supervisory Responsibilities:
- Supervisors on day and night shifts, other staff as
- Bachelor's degree preferably in Science, Engineering, or other
related field and six (6) years of relevant experience; (4) four of
which should be in GMP manufacturing; OR
- Associate degree preferably in Science, Engineering, or other
related field and eight (8) years of relevant experience; (5) five
of which should be in GMP manufacturing; OR
- High school / GED in a related field and ten (10) years of
relevant experience; (6) six of which should be in GMP
- Experience with Downstream Processes- Clarification, TFF, UFDF,
AFF, Chrom, AKTA, etc. AND
- Experience with Mammalian Cell, Insect Cell, Yeast and
Bacterial Cell Lines; AND
- Experienced with MAb, pDNA, and Viral Propagation technologies;
- Single use technology experience; AND
- (4) four years' of management / supervisory experience is
- Experience in logistics/planning
- Lean Six Sigma - Black Belt
Keywords: FUJIFILM Holdings America Corporation, College Station , Manufacturing Manager, Downstream, Executive , College Station, Texas
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