Scientist, Upstream Process Development
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
|
|
Job Description:
Overview Summary: The Upstream Process Development Scientist is
responsible for driving the development of new cell culture and
fermentation processes at laboratory scale, scale up to
manufacturing scale, and transfer of client processes into Process
Development as well as transfer of processes to Manufacturing.
Projects include, but are not limited to, cell and virus culture,
cell banking, batch and fed batch processing and in-process
testing. The successful candidate will also participate in process
verification/validation of transferred processes. The individual
should display strong technical knowledge and scientific
understanding of cell and virus culture, expansion, harvest, medium
development, clone selection and development, and DOE studies, as
well as having experience in process development with both small
and large process scales for vaccine development. The individual
will lead multiple projects and is expected to provide significant
scientific and technical contributions within the Process
Development Group and will work closely with other Departments to
develop strong working relationships.External US Essential
Functions:* Develop, optimize, and scale-up bacterial and mammalian
cell and virus/viral vector-based processes, including cell
banking, adherent and suspension cell cultures in batch, fed-batch,
and perfusion modes.* Plan, generate and execute protocols for DOE
studies that include appropriate statistical analysis and generate
and present reports.* Plan and perform metabolite/spent medium
analyses, medium development and cell line development studies.*
Assemble, operate, and troubleshoot single-use stirred tank
bioreactors from bench scale to 200L working volume scale.* Plan
and execute various centrifuge and cell/virus culture harvest
protocols.* Support GMP manufacturing through tech transfer,
training, and master batch record generation and review.* Generate
scientific reports, including process development reports,
manufacturing summary reports, and supportive reports for IND CMC
sections.* Cross-train in Downstream PD, Virology and Analytical
Development groups to gain knowledge and functional capability in
these areas.* Plan, perform and evaluate relevant in-process assays
and report results.* Generate and present oral presentations for
peers and senior management, as required.* Ensure maintenance and
monitoring of process development equipment.* Manage direct reports
to be engaged and productive, and address work productivity issues
as they arise.* Ability to work effectively in a matrix management
environment.* Perform all other duties as assigned.Required Skills
& Abilities:* Experience in upstream process development of
mammalian, viral and bacterial cultures and upstream purification
of biological products. Experience monitoring the performance of
laboratory processes and equipment.* Strong working knowledge of
cGMP (current Good Manufacturing Practices).* Ability to work
independently and within a team.* Ability to provide observations
within a developing process.* Strong attention to detail.*
Excellent verbal, written and organizational skills.* Strong
computer skills (Microsoft Office products including Excel, Word,
Outlook and PowerPoint).* Strong organizational and analytical
skills.* Strong interpersonal and leadership skills.Preferred
Skills & Abilities:* Experience with cGMP operations,
manufacturing, QA, QC, and regulatory requirements for
pharmaceutical products.* Experience performing Phase 1 clinical
manufacturing.* Experience in performing analytical methods
supporting process development and/or GMP manufacturing.* Strong
background in virology and microbiology.Supervisory
Responsibility:Carries out supervisory responsibilities in
accordance with company policies and applicable laws including
interviewing, hiring, planning, assigning, directing work, training
and development, disciplinary actions, performance reviews,
addressing complaints and resolving problems. 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 standing, along with some bending, stooping,
and stretching.* Use hand-eye coordination and manual dexterity
sufficient to operate a keyboard, photocopier, telephone,
calculator, and other office equipment.* Attendance is mandatory.*
Ability to occasionally travel to other sites, vendor locations,
and/or conferences.Minimum Qualifications:* Master's Degree
preferably in Chemistry, Biology, Life Sciences or related field,
with four (4) years of relevant experience; OR* Bachelor's Degree
preferably in Chemistry, Biology, Life Sciences or related field,
with five (5) years of relevant experience.Preferred
Qualifications* Leadership in a regulated/biotech environment
producing viral vaccines.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Scientist, Upstream Process Development, Other , College Station, Texas
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Other JobsDelivery Runner Description: Are you looking for a flexible way to earn extra cash daily, make your own schedule, and provide a great experience to customers, all while Company: Favor Location: Pflugerville Posted on: 01/16/2021 Clinical Coordinator, Lead RN 10k Sign On Bonus! (Must Have Dialysis Experience) Description: 2606 W Pecan StBldg 3, Ste 300,--Pflugerville,--Texas,--78660-1917,--United States of America n n n n n n As a Clinical Coordinator at DaVita you will have the opportunity to excel as the superior (more...) Company: DaVita Location: Pflugerville Posted on: 01/16/2021 PACU RN Travel Nurse Description: Nationwide Travel Nurse Jobs - Pre-Op / Post-Op RN Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...) Company: HealthCare Travelers Location: Georgetown Posted on: 01/16/2021 Favor-Delivery-Driver (No Experience Needed & Flexible) Description: Are you looking for a flexible way to earn extra cash daily, make your own schedule, and provide a great experience to customers, all while Company: Favor Location: Pflugerville Posted on: 01/16/2021 PICU Nurse - Pediatrics Intensive Care RN Travel Description: Pediatric Intensive Care RN - Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking (more...) Company: HealthCare Traveler Jobs Location: Pflugerville Posted on: 01/16/2021 Automotive Detailer Overnight Description: 7154 - Austin - 13300 North I-35 Service Road South, Austin, Texas, 78753CarMax, the way your career should be When our vehicles shine, you will shineCarMax customers expect to choose from a range of (more...) Company: CarMax Location: Georgetown Posted on: 01/16/2021 Runner/Delivery Driver Description: Are you looking for a flexible way to earn extra cash daily, make your own schedule, and provide a great experience to customers, all while Company: Favor Location: Pflugerville Posted on: 01/16/2021 Travel ICU RN / Crisis COVID-19 - Intensive Care Unit Description: Intensive Care Unit RN - Nationwide Travel Nurse Assignments Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for (more...) Company: HealthCare Traveler Jobs Location: Pflugerville Posted on: 01/16/2021 Experienced Travel RNs - ICU, CVICU, SICU, MICU, NICU, PICU Description: Travel Nurses Needed - All RN Specialties br Registered Nurses: Critical Care ICU, CVICU, SICU, MICU br Hospitals are posting their seasonal staffing needs br Would you like to spend the fall / (more...) Company: RN Travel HealthCare Jobs Location: Pflugerville Posted on: 01/16/2021 Crew Description: The Crewmember - At Raising Cane's, What We Do is serve the Perfect Box, Fast, Friendly, Clean Have Fun A Crewmember has the primary responsibility of providing a positive Customer experience, including (more...) Company: Raising Cane's Location: Pflugerville Posted on: 01/16/2021 |