Manufacturing Supervisor
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 11, 2021
|
|
Job Description:
Overview SummaryThe Manufacturing Supervisor may be assigned to
work directly with Upstream, Downstream or Buffer Preparation Unit
Operations. This individual will supervise a team of employees
directly or indirectly in these production process units.External
US Essential Functions Operational oversight of the following
systems dependent upon assignment:Upstream Unit:* Single-Use Cell
Culture Vessels/Bioreactors up to 2000L* Bacterial Fermentation
Culture Vessels up to 2000L* Alpha Wasserman Continuous Flow
Centrifuges* Disposable Magnetic Mixing Bags and Totes* Cell
Expansion and Propagation* Banking/Cryopreservation of Cell Lines
and Viruses* Hyperstack, Cellstack and other adherent cell
technologies * Plate counting, microscopic examination* Monitor
cultures, take samples, turn-around of bioreactor and fermenters,
sterilization, and inoculationDownstream Unit:* Medium to
Large-scale filtration systems including Tangential Flow Filtration
(TFF) Hollow Fiber Tangential Flow Filtration (HFTFF),
Nanofiltration and depth filtration.* Medium to Large-scale
Chromatographic systems (--KTA)* Pre-Packed Columns from 1L to
100L* Single use mixing systems (Pall & GE)* Single Use
connectivity types such as GE DAC and Colder AseptiQuik* Plate
counting, microscopic examination* Monitor cultures, take samples,
turn-around of bioreactor and fermenters, sterilization, and
inoculation* Bulk filling* Aseptic process simulation and drug
product fillingBuffer Preparation Unit:* Preparation of medium from
stock raw materials including the compounding, mixing, testing and
filtration for further process needs* Preparation of buffers from
stock raw materials including the compounding, mixing, testing and
filtration for further process needs* Weighing of raw materials per
batch record specifications and assignment of appropriate expiry
per procedures* Integrity testing of filtersAll Units:* Responsible
for supervising daily manufacturing activities and staff, including
hiring, performance evaluations, coaching, mentoring, disciplinary
actions, termination recommendations, training, development, etc.*
Responsible for implementing project safety and quality assurance
programs* Execution of SAP functionality for batch close out and
generating SAP reports as required.* Develop, write, and review
Standard Operating Procedures, Buffer Formulation Records and Batch
Production Records (BPRs).* Responsible for ensuring proper
documentation and execution of BPRs and activity records, according
to cGMP regulations.* Lead deviation resolution and closure with
subject matter expert and quality teams.* Responsible for tracking
CAPAs to closure.* Provide input and support to R&D functions
during development and scale up activities as necessary.*
Represents organization in client meetings as the subject matter
expert with regard to assigned manufacturing processes.* Ensure an
adequate supply of materials available; ensure all materials for
project are procured prior to production.* Maintain the
confidentiality of proprietary company information.* Responsible
for continuous improvement in areas of responsibility.* Maintain an
effective working relationship with others.* Perform all other
duties as assigned.Required Skills & Abilities:* Demonstrated
leadership, coaching and mentoring skills.* Demonstrated experience
in training others to perform and maintain cGMP standards*
Excellent skills with Microsoft Office applications.* 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.* Excellent self-discipline
and attention to detail.* Advanced math and computer skills.* Must
have exceptional planning and organizational skills, excellent oral
and written communication skills, and be proactive in process
interfacing with colleagues in various roles and functions
throughout the manufacturing facilities.* Demonstrated ability to
work with teams and collaborate with others.* Excellent
problem-solving skills.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, pushing, pulling, reaching above
the shoulder, stooping, and stretching.* Use hand-eye coordination
and manual dexterity sufficient to operate a keyboard, photocopier,
telephone, calculator, and other office equipment.* Potential for
exposure to hazardous chemicals, gases, fumes, odors, mists, and
dusts, and other hazardous materials.* Ability to wear personal
protective equipment including safety glasses, lab coat, safety
shoes and gloves. * Ability to lift/pull/push up to 25 pounds
frequently and up to 50 pounds on occasion.* Attendance is
mandatory.Minimum Qualifications:* Master's degree in Biology,
Microbiology, Chemistry, Biochemistry, Engineering, or related
field with 3 years of experience in a manufacturing environment.*
Undergraduate degree in Biology, Microbiology, Chemistry,
Biochemistry, Engineering, or related field with 5 years of
experience in a manufacturing environment* Associate's degree in
Biology, Microbiology, Chemistry, Biochemistry, Engineering or
other related field and 7 years of relevant experience; OR* High
School/GED with 9 years of relevant experience.* Previous
experience in a leadership or supervisory role.* A minimum of 3
years of experience in a GMP environment.Preferred Qualifications:*
Biotechnology Certificate* Green-Belt Certification* Experience
with mammalian, insect, yeast, or bacterial cell lines and their
cultivation and/or purification of biologics or viral vectors
produced from such.We 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 FDBTHR@fujifilm.com or
call 979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Manufacturing Supervisor, Other , College Station, Texas
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Other JobsTravel CT Tech - $2,055 per week Description: Cross Country Allied is seeking a travel CT Tech for a travel job in Georgetown, Texas.Job Description Requirements ul li Specialty: CT Tech li Discipline: Allied Health Professional li Start (more...) Company: NurseFly Location: Georgetown Posted on: 01/17/2021 Toolmaker/Moldmaker Description: Who we are At Cantel, preventing infection is our business. As a leading provider of infection prevention products and services in the healthcare market, we are dedicated to delivering high-quality, innovative (more...) Company: Cantel Medical Location: Conroe Posted on: 01/17/2021 Travel CT Tech - $1,875 per week Description: Med Travelers is seeking a travel CT Tech for a travel job in Georgetown, Texas.Job Description Requirements ul li Specialty: CT Tech li Discipline: Allied Health Professional li Start Date: (more...) Company: Med Travelers Location: Georgetown Posted on: 01/17/2021 Mechanical Assembler Description: HIRING NOW DescriptionOpening for Mechanical Assembler/Disassemblers. These positions will report into their maintenance teams. These positions will require people to disassemble the food processing (more...) Company: Aerotek Location: Lampasas Posted on: 01/17/2021 Travel Speech Language Pathologist - $1,887 per week Description: Med Travelers is seeking a travel Speech Language Pathologist for a travel job in Conroe, Texas.Job Description Requirements ul li Specialty: Speech Language Pathologist li Discipline: Therapy (more...) Company: Med Travelers Location: Conroe Posted on: 01/17/2021 Deliver with Uber Eats - Great for Students Description: Deliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends it's up to you. Earn Good Money. You'll earn by bringing people (more...) Company: Uber Eats Location: Franklin Posted on: 01/17/2021 Senior Operator Specialist-Foams Description: Senior Operator Specialist OM ThermoformingThis position is for Pactiv Evergreen Inc.At Pactiv, the health and safety of our employees is a top priority. In response to the COVID-19 pandemic and in (more...) Company: Pactiv Corporation Location: Temple Posted on: 01/17/2021 Travel Speech Language Pathologist - $1,887 per week Description: Club Staffing is seeking a travel Speech Language Pathologist for a travel job in Conroe, Texas.Job Description Requirements ul li Specialty: Speech Language Pathologist li Discipline: Therapy (more...) Company: Club Staffing Location: Conroe Posted on: 01/17/2021 Postal Mail Carrier Description: Postal Mail Carrier: br Duties and Responsibilities: ul li The Mail Carrier is responsible for sorting mail of all classes in delivery sequence for the assigned area or route. li The Mail Carrier (more...) Company: USPH Location: Temple Posted on: 01/17/2021 Lube Tech - Part Time/Full Time - Conroe, S Loop 336 W Description: Geared for the Driven-------------- During these uncertain times of COVID-19, Valvoline Instant Oil Change SM VIOC is proud to serve those who need to be on the road, including first responders and (more...) Company: Valvoline Instant Oil Change Location: Conroe Posted on: 01/17/2021 |