Laboratory Associate II, GMP

Posted 4 Days Ago
Be an Early Applicant
Redwood City, CA, USA
In-Office
Junior
Biotech
The Role
Operate and verify synthesis, purification, and fill/finish of clinical-grade oligonucleotides under GMP/GLP. Run automated lab equipment, execute batch records, capture production data, troubleshoot equipment, maintain inventory, collaborate with cross-functional teams, and assist with SOP/batch record revisions and training.
Summary Generated by Built In
Synthego is enabling genome engineering at scale with a blend of scientific instrumentation, industrial automation, and data science. Our team of scientists and engineers are putting multidisciplinary fields together to solve problems that no one field can tackle alone.
 
We are searching for motivated, enthusiastic, and hands-on individuals interested in advancing science through the manufacturing of our CRISPR regulated products. As a Lab Associate at Synthego, you will join our Clinical operations team and have direct responsibility for the synthesis and purification of our sgRNA products in the INDe and GMP factories. This role requires a strong attention to detail, a desire to learn and adapt to new processes, and familiarity with safe laboratory practices. This role will combine hands-on laboratory protocols with advanced automation to ensure the timely delivery of high quality products to our customers.
 

Available Shift and Training Schedule:

  • Shift: Day Shift
  • Hours: 6:30am to 3:00pm 
  • Days: Monday - Friday
  • Training: Training will take up to 3 months. During the training period you may be asked to temporarily move to a different shift time due to staffing and training needs. After training is complete, you will work the hours/days of the week you were hired for.

What You'll Do:

  • Operate and verify in the synthesis, purification, and fill/finish operations for clinical grade oligonucleotides by following established SOP’s
  • Operate complex lab equipment systems to manage product formulation through an automated workflow
  • Execute batch production records or protocols independently, efficiently, and in compliance with site and quality management system requirements.
  • Handle chemical solutions
  • Ensure laboratory products and supplies are maintained and stocked
  • Capture production data in compliance with site and quality management system requirements
  • Collaborate with Supply chain, Quality Assurance, Warehouse, and other cross-functional teams to meet deadlines.
  • Troubleshoot routine process and equipment issues under supervision
  • Assist in authoring revisions of SOPs, work instructions, and batch records 
  • Train other Laboratory Associate team members on manufacturing processes 
  • Utilize ERP system to submit material requests, track inventory, and support production planning
  • Perform batch record review for accuracy, completeness, and compliance prior to submission to Quality

About You:

  • Bachelor’s degree in chemistry or a related field
  • 1–2 years of experience in a GMP or GLP-regulated manufacturing environment
  • Understanding of quality concepts and familiarity with Quality Management Systems (QMS)
  • Great communication skills and able to work with various personalities
  • Strong desire to work in a fast-paced, collaborative startup environment
  • Demonstrates strong interpersonal skills, as well as a strong commitment to quality
  • Demonstrates ability to work independently and as part of a team
  • Must be able to lift/move up to 25 pounds
  • Must be able to sit and/or stand for extended periods up to four (4) hours at a time

Nice to Have:

  • Experience working with oligonucleotides
  • Experience working with aseptic fill/finish operations  
  • Experience working with chromatography systems 

Our Mission
Synthego® is a pioneering force in the biotechnology industry, dedicated to advancing the frontiers of CRISPR cell and gene therapies through cutting-edge CRISPR technology and expertise. Our mission is to provide unparalleled access to CRISPR solutions at scale, empowering applications from Discovery to Clinic. Driven by a visionary approach, we strive to accelerate the therapeutic development process with best-in-class CRISPR solutions, simplified licensing & expert guidance, driving the adoption and success of CRISPR-based therapies to benefit all patients.

Skills Required

  • Bachelor's degree in chemistry or related field
  • 1-2 years experience in a GMP or GLP-regulated manufacturing environment
  • Understanding of quality concepts and familiarity with Quality Management Systems (QMS)
  • Familiarity with safe laboratory practices and ability to follow SOPs
  • Ability to execute batch production records and capture production data in compliance with quality requirements
  • Ability to operate complex lab equipment and automated workflows
  • Strong communication and interpersonal skills; ability to work independently and in teams
  • Ability to lift/move up to 25 pounds
  • Ability to sit and/or stand for up to four hours at a time
  • Experience working with oligonucleotides
  • Experience with aseptic fill/finish operations
  • Experience with chromatography systems
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The Company
HQ: Menlo Park, CA
443 Employees
Year Founded: 2012

What We Do

Synthego is a genome engineering company enabling the acceleration of life science research and development in the pursuit of improved human health. The company leverages machine learning, automation, and gene editing to build platforms for science at scale. By vertically integrating hardware, software, bioinformatics, chemistry, and molecular biology, Synthego is at the forefront of innovation advancing the next generation of medicines through providing access to genome editing at an unprecedented scale. //// Our Culture of Diversity: Different Faces from Different Places At Synthego, our differences make us unique, help us innovate, and allow us to persevere. We stand firmly behind our values, strive to achieve representation, and celebrate diversity in perspectives and backgrounds. We welcome all team members to be their best selves as we move forward towards fulfilling our shared vision of revolutionizing genome engineering technology to help make biological therapies accessible to all patients.

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