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Manufacturing Specialist

4D Molecular Therapeutics

4D Molecular Therapeutics

Operations
Emeryville, CA, USA
Posted on Friday, May 31, 2024

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators:

• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY:

4DMT is in need of a motivated, team-oriented, and experienced Manufacturing Specialist. This individual will join a small but skilled manufacturing team to deliver novel AAV vectors for gene therapy clinical trials. The Manufacturing Specialist will interface with Process Development to transfer new candidates into GMP production, and provide support for experiments as needed.

RESPONSIBILITIES:

  • Execute upstream and solutions preparation unit operations for the manufacture of AAV vector products in a cGMP environment, using proper aseptic technique, good documentation practices, and sound scientific methods. Operations include:
  • Mammalian cell culture processing in flatware/shake flask and adherent/stirred tank bioreactors for both cell expansion and/or vector production
  • Transfection
  • Cell lysis to harvest
  • Depth filtration and tangential flow filtration (TFF)
  • Act as SME in cell culture processes, including media/buffer preparation, cell passaging, bioreactor production, DNA digestion and harvest clarification operations. SME will be required to:
  • Lead investigations related to upstream manufacturing operations and report/present to stakeholders, as needed.
  • Generate operational protocol(s) and internal documents including remediation and investigation plans, SOPs, master batch records, deviations.
  • Perform and lead risk assessments, gap assessments and change controls as it relates to implementing process changes
  • Cross-trained to different operational areas, e.g., column chromatrography using chromatrography system/UNICORN software and fill/finish with both manual and automated methods.
  • Engage and support the Process Development team in transfer of new projects and scale-up of processes into GMP manufacturing. Identify and elevate processing issues (large and small) and implement solutions. Provide feedback and/or suggested changes to operational procedures.
  • Complete batch production records under cGMP & tech transfer systems to meet both operational and compliance requirements.
  • Troubleshoot equipment problems; work with Facilities to maintain calibration, maintenance and operation requirements of manufacturing equipment. Perform environmental monitoring activities during aseptic processing.
  • Work closely with supervisors for setting the manufacturing schedule to meet timelines and avoid operational delays.
  • Work closely with Materials Management to keep the cell culture and solution preparation areas stocked with all raw materials/ process inputs.
  • Participate in new facility expansion and equipment validation activities as needed.
  • Have a strong understanding of GMP procedure for clinical production of complex biologics.
  • Follow all QA procedures, including deviation reporting. Lead deviation investigations.
  • Shift and/ or weekend work may be required

QUALIFICATIONS:

Education:

  • BS in bioprocessing, chemical engineering, biochemistry or biology preferred
  • Biotechnology program certifications considered, as well as experience providing technician support in an academic setting.

Experience:

  • At least 10 years of cGMP manufacturing experience in biopharmaceutical industry

Skills:

  • Familiarity with cGMP requirements is essential.
  • Knowledge of mammalian, insect and viral vector processes. Experience with adherent cell cultures, suspension cell cultures, and/ or disposable single-use adherent/stirred tank bioreactors is highly desired.
  • Aseptic gowning/ cleanroom experience is highly desired.
  • Excellent time management skills and the ability to multi-task and adapt to changing priorities.
  • Ability to thrive and succeed in a team-oriented entrepreneurial environment, and provide leadership in a growing organization.
  • Proficient with Excel, Word, and PowerPoint.
  • Excellent written and oral communication skills.

Physical Requirement

  • Capable of strenuous, repetitive, physical work, including bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 40 pounds.
  • Pass a visual acuity test and color blindness test with or without corrective lenses.

Bay Area Range: $130,000/yr - $176,000/yr

Please note that compensation varies on a variety of factors including experience, location, etc.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities