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Manufacturing Associate - Contractor

Employer
4D Molecular Therapeutics
Location
Emeryville, CA, United States
Start date
Dec 19, 2020

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Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Biotech Bay
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Job Details

4D Molecular Therapeutics (4DMT) is a gene therapy company with a transformative discovery platform—Therapeutic Vector Evolution—that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits, and provides challenging opportunities for career development. Join us in creating the ultimate gene therapy products to cure genetic diseases in children and adults. 4D Molecular Therapeutics, located in Emeryville, CA.

GENERAL SUMMARY:

4DMT is in need of a motivated, team-oriented, and experienced Manufacturing Associate. This individual will join a small but skilled manufacturing team to deliver novel AAV vectors for gene therapy clinical trials. The Manufacturing Associate will interface with Process Development to transfer new candidates into GMP production, and provide support for experiments as needed. This is a 6-month contract role with potential to convert to full time employment.

RESPONSIBILITIES:
  • Execute downstream and fill finish 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:
  • Column chromatography purification (AKTA Pure, Avant, Pilot systems)
  • Depth filtration and tangential flow filtration
  • Formulation and filling of drug product
  • Manual visual inspection
  • Solve operational tasks in the operation of purification processes, including column packing, UNICORN method writing, filtration assembly design, and aseptic filling via manual and automated processes.
  • Cross-trained to different operational areas, e.g., buffer/ media preparation and upstream cell culture of adherent and suspension cells.
  • 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.
  • Contribute to operational protocol(s) and internal documents including SOPs, master batch records, deviations.
  • Troubleshoot downstream/ fill finish processes and 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 downstream and fill finish 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. Support 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 2 years of of cGMP manufacturing experience in biopharmaceutical industry
  • Ability to work in a small company environment


  • Skills:
  • Familiarity with cGMP requirements is essential.
  • Knowledge of affinity, ion exchange, and/ or multi-modal purification processes.
  • Aseptic gowning/ cleanroom experience is highly desired.
  • Familiarity UNICORN software and/ or designing single-use assemblies is preferred
  • ·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 Requirements
  • 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 visual acuity test and color blindness test
  • Able to work on site during COVID pandemic and adhere to 4DMT's safety protocols


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

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.


At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.


While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.


At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.


4D Purpose Statement:  Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients


GUIDING PRINCIPLES

 

  • Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
  • Break Boundaries - Question the status quo and innovate beyond conventional approaches
  • Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
  • Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans


We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development. 
 

Company info
Website
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
United States
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