Production Specialist

Clinical Operations

Updated on 5/26/2023

Locations

San Carlos, CA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Communications

Requirements

BS/MS in Chemistry or a relevant sciences field
2+ years of pharmaceutical and/or industry experience in cGMP/cGLP a plus
Desire to work in a fast-paced, collaborative startup environment
Experience running HPLC and solid phase extraction workflows a plus
Strong commitment to quality
Demonstrates strong interpersonal and communication skills (both written and verbal)
Ability to work independently and as part of a team, to meet departmental goals
Self starter who is comfortable working with limited guidelines
Able to lift/move up to 25 pounds
Comfortable to sit and/or stand for extended periods (up to 4 hours)

Responsibilities

Responsible for end-to-end oligonucleotide manufacturing including reagent preparation, equipment set-up, synthesis and post-processing (cleavage and deprotection, purification, and lyophilization) of GMP sgRNA products
Follow established SOPs and revise SOPs, as necessary to ensure compliance
Properly record, analyze, and maintain batch records and supporting data per good documentation practices
Execute batch production records or protocols independently, efficiently, and in compliance with site and quality management system requirements
Collaborate with Supply Chain, Quality Assurance, Warehouse, and other cross-functional teams to meet deadlines
Practice continuous improvement by contributing ideas and suggestions to new and existing processes
Operate complex robotic high-throughput systems to manage products through a highly automated workflow
Organize, stock, and maintain work area to 5S and safety standards
Capture production data in compliance with site and quality management system requirements
Identify, communicate, and escalate processing or quality related issues
Ability to author documents such as protocols, change control records, deviation, master production records and SOPs

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, efficient, and hands-on individuals interested in advancing science through the manufacturing of our CRISPR products. As a Production Specialist at Synthego, you will join our growing operations team and have direct responsibility for the end-to-end manufacturing of our GMP sgRNA products. This role requires strong attention to detail, experience working in a GMP-compliant environment, and oligonucleotide manufacturing.

Swing Shift:

2:30pm-11:00pm - Sunday through Thursday

Training Schedule:

For the first week of employment, the training for this position will be conducted from Monday to Friday, from 6:30 am to 3:00 pm. After the completion of training, you will work the hours and days of the week for which you were hired.

What You’ll Do

Responsible for end-to-end oligonucleotide manufacturing including reagent preparation, equipment set-up, synthesis and post-processing (cleavage and deprotection, purification, and lyophilization) of GMP sgRNA products
Follow established SOPs and revise SOPs, as necessary to ensure compliance.
Properly record, analyze, and maintain batch records and supporting data per good documentation practices
Execute batch production records or protocols independently, efficiently, and in compliance with site and quality management system requirements
Collaborate with Supply Chain, Quality Assurance, Warehouse, and other cross-functional teams to meet deadlines
Practice continuous improvement by contributing ideas and suggestions to new and existing processes
Operate complex robotic high-throughput systems to manage products through a highly automated workflow
Organize, stock, and maintain work area to 5S and safety standards
Capture production data in compliance with site and quality management system requirements.
Identify, communicate, and escalate processing or quality related issues.
Ability to author documents such as protocols, change control records, deviation, master production records and SOPs.

About You

BS/MS in Chemistry or a relevant sciences field
2+ years of pharmaceutical and/or industry experience in cGMP/cGLP a plus
Desire to work in a fast-paced, collaborative startup environment
Experience running HPLC and solid phase extraction workflows a plus
Strong commitment to quality
Demonstrates strong interpersonal and communication skills (both written and verbal)
Ability to work independently and as part of a team, to meet departmental goals
Self starter who is comfortable working with limited guidelines
Able to lift/move up to 25 pounds.
Comfortable to sit and/or stand for extended periods (up to 4 hours)

Company Perks & Benefits

Generous equity
Medical, dental, and vision benefits
401k Program
Subsidized catered lunches and dinners with fully stocked kitchen & snacks
Onsite Gym
Daily Shuttle bus to & from San Francisco
Paid parental leave
Flexible paid time off
Learning and Development resources

About Us

Synthego is a genome engineering company that enables 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. With its foundations in engineering disciplines, the company’s platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.

By providing both commercial and academic researchers and therapeutic developers with unprecedented access to cutting-edge genome engineering, Synthego is at the forefront of innovation, accelerating the development of truly engineered biology.

201-500 employees

Website

Next-gen genome engineering

Company Overview

Synthego’s mission is to enable agile life science research and development from discovery through clinical introduction by providing scientists unprecedented access to advanced genome engineering products at high throughput.

Benefits

Generous Equity Package
Medical, Dental & Vision
401(k) Plan
Catered to You
Fully Stocked
Transportation
Green Environment
Stay Fit
Legal Ease