Laboratory Associate II, GMP

Job Description

Job Description

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.

• 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.

• 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

• 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

• 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.