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Director - Molecular Analysis

Employer
FUJIFILM Diosynth Biotechnologies
Location
College Station, TX
Start date
Sep 18, 2022
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Job Details

The Director of Molecular Analysis will provide expert knowledge in advanced molecular biology based analytical methods and establish at FOB key techniques such as NGS and nanopore sequencing; RNASeq; PCR based methodologies as QC tests and advise FOB on opportunities to expand molecular characterization services.

External US

 

Essential Functions:

  • Define appropriate methods I software platforms for storing, assembling, and interpreting large volumes of sequence data.
  • Establish wet lab at FDBT with appropriate cross contamination controls to offer molecular biology-based analysis and characterization methods supporting client projects across FOB such as:

Routine Testing

  • Entry testing of cell lines and viral stocks, bulk harvest and BOS testing using NGS and confirmatory specific PCR methods to identify pathogens. Define FOB strategies for avoiding confounding factors such as physical contamination and computational artifacts that lead to false virus identification
  • Rapid PCR based myoplasma testing of cell lines and materials
  • Microbial cell bank testing - g., plasmid sequence, copy number, molecular confirmation of ID

Viral Vector Characterization

  • Methods to characterize AAV and other viral vector payloads g., % GOI vs plasmid vs host cell DNA
  • Quantification and sizing of unpackaged host cell DNA

 

          CHO Cell Line Characterization

  • Molecular characterization of recombinant cell lines g., transgene copy number, confirmation of expressed gene integrity (no errors).
  • Establish systems to allow genome wide comparison of recombinant cell lines with ApolloX parent.
  • Establish RNASeq to characterize differential gene expression in cell lines

 

  • Continually explore how molecular characterization techniques could be applied to other systems (e.g., baculovirus based expression) and emerging technologies (e.g., mRNA, cell therapies) to enable FOB to better develop, understand and control client processes.
  • Actively participate in external expert groups (e.g., BPOG) to maintain awareness of state of the art and to promote FOB's interest in and use of advanced molecular analytical methods.
  • Mentor and manage junior staff and liaise more widely with scientists at FF corporate labs in Japan and elsewhere in FOB to build consensus methods and raise awareness of availability and value of molecular

Required Skills & Abilities:

  • Proven track record in establishing and running a molecular analytical lab with direct experience of NGS techniques and nucleic acid-based techniques such as PCR, qPCR and ddPCR
  • Experience in assembly and analysis of sequencing data sets and a general understanding in experimental design and analysis (DOE, JMP, R etc.)

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.
  • Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
  • Ability to lift 50 pounds on occasion and 25 pounds regularly.
  • Ability to wear PPE. 
  • Attendance is mandatory.

Minimum Qualifications:

  • PhD with emphasis on molecular biology, biochemistry, microbiology, or related life science with a minimum of 10 years of experience; OR
  • MS with emphasis on molecular biology, biochemistry, microbiology, or related life science with a minimum of 12 years of experience; OR
  • BS with emphasis on molecular biology, biochemistry, microbiology, or related life science with a minimum of 17 years of experience
  • At least 8 years of supervisory/management experience.

 

Preferred Qualifications:

  • Experience in pharmaceutical or biotechnology industry with cGMP experience

 

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 979-431-3500.

Company

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.

Our Process Development experience includes the development of processes for molecules expressed via fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.

Our network expands within five development and manufacturing facilities located in Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, Thousand Oaks CA USA and Hillerød, Denmark.

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Find Us
Website
Phone
919-337-4400
Location
Thousand Oaks, CA
Research Triangle Park, NC
College Station, TX
Holly Springs, NC
Watertown, MA
United States
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