CollegeStationRecruiter Since 2001
the smart solution for College Station jobs

Senior Manufacturing Lead - Upstream

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 11, 2021

Job Description:

Overview Summary: The Senior Manufacturing Lead - Upstream will lead a team and work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment.External US Essential Functions:* Responsible for leading a team in preparing medium, monitoring cultures, taking samples, turn-around of bioreactors and inoculations.* Responsible for coordinating daily manufacturing floor activities.* Responsible for overseeing and/or performing cell counting and microscopic examination.* Responsible for writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).* Coordinate and implement project safety and quality assurance programs in collaboration with senior staff and EH&S.* Maintain confidentiality of proprietary company information.* Document and maintain activity records according to cGMP regulations and ensure team members are properly trained on all proper processes.* Maintain an effective working relationship with others.* Ensure proper documentation and execution of Batch Production Records for assigned projects.* Participate in and/or lead incident investigations.* Perform all other duties as assigned.NCTM/Building 200 Essential Functions:* Operation of the following systems:* Single-Use Cell Culture Vessels/Bioreactors up to 1000L* Bacterial Fermentation Culture Vessels up to 1000L* Alpha Wasserman Continuous Flow Centrifuges* Disposable Magnetic Mixing Bags and Totes* Cell Expansion and Propagation* Banking/Cryopreservation of Cell Lines and Viruses* Lead team in cell-culture and viral propagation techniques; cell-culture and bioreactor operations; bacterial and fermentation operations; pDNA, protein, and yeast-related operations; and aseptic techniques.* Provide input and support to Process Development functions during development and scale up activities.Building 100 Essential Functions:* Lead team in working with mammalian cell culture processes including: shake flask inoculations, single use bioreactor operations, cell recovery, etc.* Lead team to produce requirements in operating and monitoring equipment through observing varying conditions, adjusting equipment controls, calculating concentrations, dilutions, and yields.* Ability to operate and train team in the use of general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc.Required Skills & Abilities:* Excellent oral and written communication skills as well as excellent interpersonal and organizational skills.* Demonstrated leadership skills.* Ability to train others to perform and maintain cGMP standards.* Strong proficiency with Microsoft Office applications.* Experience working in cleanroom environments.* Self-discipline and good attention to detail.* Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hour and weekends as required.* 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 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, 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.Minimum Qualifications:* Master's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 3 years relevant experience of which 2 years must be in a GMP environment; OR* Bachelor's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 5 years relevant experience of which 2 years must be in a GMP environment; OR* Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 7 years relevant experience of which 2 years must be in a GMP environment.* High School Diploma or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 9 years relevant experience of which 2 years must be in a GMP environment.* Experience with cultivation of cell culture vessels at the pilot scale level or greater.* Experience with Mammalian Cell or Insect Cell, Yeast or Bacterial Cell Lines.* Experience with MAb, pDNA, and/or Viral Propagation technologies.Preferred Qualifications:* Six Sigma Certification

Keywords: FDBT - FUJIFILM Diosynth, College Station , Senior Manufacturing Lead - Upstream, Other , College Station, Texas

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Cook
Description: The Crewmember ndash 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, (more...)
Company: Raising Cane's
Location: Pflugerville
Posted on: 01/22/2021

Delivery 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 having fun
Company: Favor
Location: Pflugerville
Posted on: 01/22/2021

Experienced Body Tech
Description: Job Summary Experienced Auto Body Technician needed to repair vehicles thoroughly, safely, and profitably in a manner consistent with Caliber S.O.P., insurance partner and industry guidelines/standards. (more...)
Company: Caliber Collision
Location: Pflugerville
Posted on: 01/22/2021


Make up to $25/Hour Delivering with Favor
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 having fun
Company: Favor
Location: Pflugerville
Posted on: 01/22/2021

*Immediate Interviews* Crewmembers - Cooks, Cashiers and Customer Service
Description: The Crewmember ndash 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, (more...)
Company: Raising Cane's
Location: Pflugerville
Posted on: 01/22/2021

Certified Medical Assistant CMA Specialty Clinic
Description: Department: Pflugerville Specialty Clinic GI, Pulm, Internal Med, Pain Management, Podiatry Ortho Schedule: Mon - Fri 8a - 5pm br JOB SUMMARY br br The Certified Medical Assistant 1, under the (more...)
Company: Baylor Scott & White Health
Location: Pflugerville
Posted on: 01/22/2021

CST II Certified Surgical Tech ENDO
Description: 5000 Signon bonus for qualified candiates. br br Great opportunity for an experieinced CST. Primary focus with be Endo, but will also participate in other areas, as well. br br br br JOB (more...)
Company: Baylor Scott & White Health
Location: Pflugerville
Posted on: 01/22/2021

Seasonal Social Worker MSW PRN
Description: JOB SUMMARY br : br br Provides patients and family members with the education and advice needed to cope with issues which arise from various emotional or physical problems as outlined by the Texas (more...)
Company: Baylor Scott & White Health
Location: Pflugerville
Posted on: 01/22/2021

Registered Nurse Tele PRN rotating shift Pflugerville
Description: Facility: Pflugerville Medical Center br br Department: ICU - Med Surg br br Shift: PRN Rotating flexible br br br br JOB SUMMARY br br The Registered Nurse RN is a licensed professional (more...)
Company: Baylor Scott & White Health
Location: Pflugerville
Posted on: 01/22/2021

Crew Member - Restaurant
Description: The Crewmember ndash 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, (more...)
Company: Raising Cane's
Location: Pflugerville
Posted on: 01/22/2021

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

College Station RSS job feeds