Manager, Reagent Manufacturing

Organization
Twist BioScience
Job Location
San Francisco, CA
Job Description

Twist is looking for an intelligent, motivated, enthusiastic  Scientist  with skills in reagent development and manufacturing for life science products to join our Twist Bioscience Operations Team in South San Francisco. This individual will work closely with the R&D, Process Development, and Operations teams to develop reagents that will ultimately be utilized in the Twist manufacturing work centers.   With the assistance of a small team, the Scientist will develop reagent manufacturing processes, formulate reagents at scale, design the QC processes, conduct stability studies and create manufacturing SOP’s.

This is an ideal opportunity for individuals who thrive in a changing environment and enjoy supporting and delivering world-class products that meet both external and internal customer needs. This is both a strategic and a tactical position and the ideal candidate will enjoy both the challenge of building new products, and the rigor and accountability of manufacturing and delivering high quality products for Twist. Those that do not want to get their hands dirty should not apply.  The ideal candidate will work independently, be very neat and organized, have basic knowledge and experience in reagent manufacture and scale up in a production environment.  Knowledge of good laboratory manufacturing practices (GLPs, GMP, ISO)  and requirements is necessary.   He/she is responsible for supplying reagents to operations. This position reports to Director of Manufacturing.

Requirements

Key Responsibilities:

  • Build and manage a reagent team that will develop, scale up and oversee the manufacture of various reagents and subassemblies for manufacturing use
  • Build systems and run the inventory and tracking of various subassemblies
  • Own the transfer and final reagent development and manufacturing activities that have been transferred from R&D
  • Transfer reagent formulation activities from the reagent team to various production teams including OEMs as needed
  • Build components for catalog kits 
  • Packaging reagents and subassemblies for internal/external customer use
  • Collaborate with the automation team to develop reagents in automation friendly formats
  • Independently design reagent development plans, perform studies, and analyze results
  • Run reagent and component stability studies
  • Develop and run reagent QC protocols
  • Maintain thorough, accurate and detailed documentation of all work produced in batch records, databases or other acceptable formats including problems and deviations
  • Define reagent specifications, processing parameters and operational boundaries
  • Use of statistical tools to establish production processes/ formulations
  • Set up part numbers and bills of material 
  • Write work instructions, SOP’s and training documents for the manufacture of reagents and for transition to manufacturing operators
  • Transition process and documents for  manufacture of reagents and for transition to manufacturing operators
  • Train manufacturing operators on proper reagent handling and usage
  • Design a reagent build schedule and scale to a plan or record based on forecast
  • Assure reagent manufacturing team functions to ISO standards 
  • Excellent verbal and written skills

Minimum Qualifications:

  • BS/MS in Biochemistry, Molecular Biology or related field
  • 5+ years industrial experience in biotechnology product development and/or technical transfer or operations
  • Experience working with cells

Required Qualifications:

  • Ability to work in a fast paced, team environment
  • Proven ability to launch products in a biotechnology or life sciences company
  • Development scale up, tech transfer and/or manufacturing experience
  • Good computer skills including experience with excel, word, Jira or similar web based programs
  • Good analytical skills
  • Knowledge of and ability to operate fermentation equipment
  • Knowledge of GMP/ISO standards
  • Experience with ERP systems such as SAP, Agile, Oracle, etc.
  • Experience with automation platforms such as Hamilton/Biomek/Tecan or Echo is a plus
How to Apply
About Our Organization

About Twist Bioscience

At Twist Bioscience, our expertise is accelerating science and innovation by leveraging the power of scale. We have developed a proprietary semiconductor-based synthetic DNA manufacturing process featuring a 10,000-well high throughput silicon platform capable of producing synthetic biology tools, including genes, oligonucleotide pools and variant libraries. By synthesizing DNA on silicon instead of on traditional 96-well plastic plates, our platform overcomes the current inefficiencies of synthetic DNA production, and enables cost-effective, rapid, high-quality and high throughput synthetic gene production, which in turn, expedites the design, build, test cycle to enable personalized medicines, pharmaceuticals, sustainable chemical production, improved agriculture production, diagnostics, biodetection and data storage. For more information, please visit www.twistbioscience.com. Twist Bioscience is on Twitter. Sign up to follow our Twitter feed @TwistBioscience athttps://twitter.com/TwistBioscience.

Twist Bioscience is an equal opportunity employer.

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