CollegeStationRecruiter Since 2001
the smart solution for College Station jobs

Senior Manufacturing Lead - Downstream

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 13, 2021

Job Description:

Overview Summary: The Senior Manufacturing Lead - Downstream will lead a team and work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation, etc. following aseptic techniques and procedures in a cGMP environment. External US Essential Functions:* Responsible for leading a team in the operation of chromatographic systems (Single Use GE AKTA).* Responsible for coordinating daily manufacturing floor activities.* Responsible for overseeing and preparing and formulating buffers 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 properly trained on all proper processes.* Coordinate and 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 and/or lead incident investigations.* Maintain an effective working relationship with others.* Perform all other duties as assigned.NCTM/Building 200 Essential Functions:* Operation and familiarity with the following systems:* Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration.* Large-scale centrifugation systems including Sucrose Density Centrifugation, Continuous Flow Centrifugation, and Clarification.* Large-scale Chromatographic systems (--KTA)* Lead team in continuous flow centrifugation, sucrose gradient separation, various filtration technologies, chromatographic separations technologies, and viral inactivation following aseptic technique in a cGMP environment.* Provide input and support to Process Development functions during development and scale up activities as necessary.Building 100 Essential Functions:* Ability to use and train employees with single use systems.* Ability to operate and train employees on general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc.* Lead team on ultrafiltration using single use technology and aseptic final fill execution.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.* 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.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 Mammalian Cell or Insect Cell, Yeast or Bacterial Cell lines.Preferred Qualifications:* Six Sigma Certification

Keywords: FDBT - FUJIFILM Diosynth, College Station , Senior Manufacturing Lead - Downstream, 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


LVN Nephrology Temple
Description: JOB SUMMARY br br The Licensed Vocational Nurse LVN is a licensed nurse who uses the BSWH nursing professional practice model to deliver patient care as part of the health care team. Using the nursing (more...)
Company: Baylor Scott & White Health
Location: Temple
Posted on: 01/23/2021

Access Services Representative II Temple Children's Part Time Weekends
Description: JOB SUMMARY br br The Access Services Representative 2 obtains current and accurate demographics and insurance information in order to register patient, verification of insurance benefits, negotiates (more...)
Company: Baylor Scott & White Health
Location: Temple
Posted on: 01/23/2021

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: 01/23/2021


Mammography Technologist PRN
Description: JOB SUMMARY br br The Mammography Technologist 1 PRN, under general supervision of a Radiologist, performs Breast Imaging procedures on ambulatory and hospital patients as requested by a physician (more...)
Company: Baylor Scott & White Health
Location: Georgetown
Posted on: 01/23/2021

Make up to $20/hour - Deliver with DoorDash
Description: Your time. Your Goals. What is DoorDash Available in over 4,000 cities in the U.S., Canada, and Australia, DoorDash is about connecting people with possibilities: bigger savings accounts, wider nets, (more...)
Company: Doordash
Location: Georgetown
Posted on: 01/23/2021

Make Up To $20/Hour - Deliver With Doordash
Description: Your time. Your
Company: Doordash
Location: Pflugerville
Posted on: 01/23/2021

Psychotherapist 1
Description: JOB SUMMARY The Psychotherapist 1 provides psychotherapy and counseling to individuals and their families, including group modalities, and assists in assessing psychotherapeutic needs of patients referred (more...)
Company: Baylor Scott & White Health
Location: Georgetown
Posted on: 01/23/2021

Make up to $20/hour - Deliver with DoorDash
Description: Your time. Your Goals. br What is DoorDash br Available in over 4,000 cities in the U.S., Canada, and Australia, DoorDash is about connecting people with possibilities: bigger savings accounts, (more...)
Company: Doordash
Location: Pflugerville
Posted on: 01/23/2021

Lead Teacher - Childcare
Description: Be a difference maker, with Learning Care Group. We are a community of collaborative, bold, fun, dedicated individuals, whose passion is the many children we guide, teach, and protect every day. As early (more...)
Company: Children's Courtyard
Location: Pflugerville
Posted on: 01/23/2021

Make Up To $20/Hour - Deliver With Doordash
Description: Your time. Your
Company: Doordash
Location: Georgetown
Posted on: 01/23/2021

Log In or Create An Account

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

College Station RSS job feeds