Manufacturing Supervisor - Drug Product Operations
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: March 15, 2023
Job Description:
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.Summary: - The Manufacturing Supervisor - Drug Product
Operations will work directly with the processes associated with
the Vanrx SA25 Automated Filling machine. - -This includes but is
not limited to formulation, aseptic filling, vial inspection and
vial labeling following cGMP procedures. - This individual will
also supervise a team of employees directly or indirectly in the
production of Drug Product at FUJIFILM Diosynth. - -
External US
Essential Functions:
- Responsible for the operation of Vanrx SA25 Vial Filling
Isolator.
- Responsible for overseeing the formulation of the bulk drug
product in accordance to procedures.
- Responsible for visual inspection and labeling of filled bulk
drug product vials in accordance to procedures.
- Responsible for writing, reviewing, and/or updating Standard
Operating Procedures (SOPs) and Batch Production Records
(BPRs).
- Document and maintain activity records according to cGMP
regulations and ensure team members are trained.
- Help implement project safety and quality assurance programs in
collaboration with senior staff and EH&S.
- Ensure proper documentation and execution of Batch Production
Records for assigned projects.
- Maintain confidentiality of proprietary company
information.
- Participate in incident investigations.
- Maintain an effective working relationship with others.
- Perform all other duties as assigned.Required Skills &
Abilities:
- Excellent oral and written communication skills as well as
excellent interpersonal and organizational skills.
- Demonstrated leadership, coaching and mentoring skills.
- Ability to train others to perform and maintain cGMP
standards
- Strong proficiency with Microsoft Office applications.
- Experience working in cleanroom environments.
- Must have flexible work hours, and be willing to work outside
of normal, scheduled hours, as necessary. Must be able to work
alternative shift hours and weekends as required.
- Self-discipline and good attention to detail.
- Excellent math and computer skills.
- Must have exceptional planning skills and be willing to
interface with colleagues in many different roles and functions
throughout the manufacturing facilities and lead projects.Working
Conditions & Physical Requirements:The physical demands described
here are representative of those that must be met by an employee,
in order to successfully perform the essential functions of this
job. - Reasonable accommodations may be made to enable individuals
with disabilities to perform essential functions. - While
performing the duties of this job, the employee is required on a
regular basis to:
- Experience prolonged standing, some bending, stooping, and
stretching.
- Use hand-eye coordination and manual dexterity sufficient to
operate a keyboard, photocopier, telephone, calculator, and other
office equipment.
- Ability to lift up to 25 pounds; frequently, and up to 50
pounds; on occasion.
- Attendance is mandatory.Hearing Conservation:
- Required to take a hearing conservation baseline test.
-Qualifications:
- Bachelor's degree in Biology, Microbiology, Chemistry,
Biochemistry, Engineering, or related field with 4 years of related
experience; 2 of which should be in a GMP manufacturing
environment; OR
- Associate degree / Technical certification in Biology,
Microbiology, Chemistry, Biochemistry, Engineering or other related
field and 6 years of relevant experience; 3 of which should be in
GMP manufacturing environment; OR
- High School/GED with 8 years of relevant experience; 4 of which
should be in a GMP manufacturing environment; AND
- At least 2 years' experience in a leadership or supervisory
role; AND
- A minimum of 2 years of experience in a GMP
environmentPreferred Qualifications:
- Six Sigma Certification
- Cross training with downstream processes or other identified
functional areas.
- Biotechnology Certificate
- SAP experience
- Train the Trainer Certification
- Drug Product experience
- Handling of Live VirusWe are an equal opportunity and
affirmative action employer. - All qualified applicants will
receive consideration without regard to race, color, national
origin, sex, gender identity, sexual orientation, religion,
disability, protected veteran status or any other characteristic
protected by applicable federal, state or local law. -If an
accommodation to the application process is needed, please e-mail
or call 979-431-3500. #LI-SB2
Keywords: FUJIFILM Holdings America Corporation, College Station , Manufacturing Supervisor - Drug Product Operations, Other , College Station, Texas
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