Manufacturing Lead, IgG Production

twistbioscience; Portland (OR); On-site; USD 85,000 - 110,000; Full time

Job summary

Twist Bioscience seeks a Manufacturing Lead to oversee manufacture and analysis of gene products across our proprietary process workflow. You will maintain the production schedule, troubleshoot issues, and guide shift associates while performing hands-on manufacturing tasks.

Responsibilities include operating lab equipment (liquid handling robots, centrifuges, thermocyclers, sequencers), maintaining thorough documentation, following SOPs, and ensuring ISO/GMP compliance in a fast-paced startup.

Qualifications

• Bachelor’s or Associate’s degree in biology, chemistry or biochemistry or equivalent lab experience.
• Familiarity with a manufacturing environment and GMP/ISO practices.
• Strong written and verbal communication skills.
• Attention to detail and ability to use computers (Excel, Word, Jira/Confluence).

Responsibilities

• Assist production supervisor and guide work on the manufacturing floor.
• Troubleshoot manufacturing processes and instrumentation.
• Take daily operations responsibility when supervisor is unavailable.
• Maintain operations with or without supervisor (equipment maintenance, production requests, review).
• Monitor material inventory and waste management for the shift.
• Oversee MES flow and report discrepancies.
• Train new laboratory manufacturing associates.
• Operate lab equipment and perform manufacturing tasks per SOPs.
• Ensure high-quality oligo-containing product manufacture in a high-throughput lab.
• Maintain proper documentation and update work instructions.
• Follow lean, ISO and GMP practices.

Skills

Attention to detail

Lab equipment operation

Documentation

Team leadership

Jira/Confluence

Excel/Word

Education

Biology / Chemistry / Biochemistry degree

Job description

The Manufacturing Lead will be responsible for the manufacturing and analysis of a variety of gene products across Twist Bioscience's proprietary process workflow to meet the Twist production forecast and timelines. The Manufacturing Lead will be held accountable for maintaining production schedule and troubleshooting, guiding the work of other shift associates while also performing manufacturing tasks. Activities will include but not be limited to: operating a variety of laboratory equipment including liquid handling robots, maintaining detailed documentation, cleaning and restocking the lab, and practicing good lab bench techniques to ensure high quality and consistent products.

The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast paced start-up environment. The Manufacturing Lead will also be responsible for the production of genes and various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule.

Shift: 1B : 7:00am-7:30pm Alternating Wednesday, Thursday-Saturday

What You'll Be Doing

• Assisting the production supervisor and guiding the work performed on the manufacturing floor by manufacturing associates.
• Troubleshooting all processes related to manufacturing process and instrumentation.
• Taking responsibility for daily operations when the supervisor is not available.
• Maintaining daily operations w/ or w/o the supervisor (equipment maintenance, fulfill production request, retain review)
• Reviewing time sensitive material and calendar events.
• Overseeing material inventory and waste management activities for the shift.
• Monitoring the flow of intermediate products through the Manufacturing Execution System (MES) and notifying the supervisor of any discrepancies.
• Reviewing JIRA tickets with supervisor to create action items.
• Enforcing checklist and auditing activities which are built into the production process.
• Training new laboratory manufacturing associates.
• Working in the laboratory and performing any process tasks.
• Manufacturing high quality custom oligo containing products in a high throughput MFG lab according to established SOPs.
• Operating laboratory equipment and liquid handling robots (Hamilton Stars, centrifuges, sealers, thermocyclers, spectrometers, Illumina Next-Gen sequencers etc.)
• Effectively using molecular and cell biology processes and techniques, especially PCR, DNA quantitation, purification and cloning.
• Maintain thorough, accurate and detailed documentation of all work performed using existing document templates and applications.
• Updating and writing work instructions and documentation.
• Working independently and in a safe manner.
• Paying great attention to detail and yielding consistent results.
• Performing troubleshooting and handling process deviations correctly.
• Analyzing data outcomes from manufacturing steps and deciding on or recommending a course of action.
• Following lean manufacturing, ISO and GMP practices.

What You'll Bring to the Team

• Bachelors/Associates degree in biology, chemistry, biochemistry: degree preferred but will consider candidates with relevant laboratory experience
• Familiarity or prior experience in a manufacturing environment
• Good written and verbal skills
• Attention to detail
• Good computer skills and comfort in using computers for all aspects of MFG, experience with excel and word, Jira/Confluence, web based or similar programs

Physical Requirements

• Ability to work in a controlled laboratory environment
• Must be able to stand for long periods of time while performing duties
• Must be able to work safely with chemicals and hazardous materials
• Must be able to lift up to 20 lbs
• Must have flexibility to work outside of regular work hours/work a flexible shift as needed